pharma - chemicals knowledge hub · 2 october/november 2019 editorial sarah harding, phd editorial...

INSIDE ...l Organic synthesis

l Biopharmaceuticals

l Pharma supply chains

l Fragrant business

l Cosmetic science

l Bioplastics

l Circular economy

l Digitalization

l Women in science

October/November 2019 www.chemicalsknowledgehub.com

FRAGRANCES

PHARMA

COSMETICS

AGROCHEMICALS

PLASTICS

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October/November 2019 1

www.chemicalsknowledgehub.com Welcome and Contents

PUBLISHING DIRECTOREllie BruniT: +44 (0) 7872 516194 E: [email protected]

EDITORIAL DIRECTOR Sarah Harding, PhDE: [email protected]

EDITORIAL CONTACT Please send your news and suggestions for feature articles to the editorial team at [email protected]

Chemicals Knowledge Hub is published by Speciality World Media Ltd: 71–75 Shelton Street, Covent Garden, London, WC2H 9JQ

DisclaimerSpeciality World Media Ltd will not be held responsible or liable for errors or omissions supplied or contained in this publication, although due care and attention are taken to ensure all content is accurate at the time of going to press. Speciality World Media Ltd also will not be held responsible for any false claims made by advertisers, or in articles contributed by external authors. The views and opinions expressed are not necessarily those of the Editor or Speciality World Media Ltd.

CopyrightThe contents of this publication are copyright © Speciality World Media Ltd 2019. No part of this publication can be reproduced or transmitted in any form without the express permission of the publisher.

ISSN 2516-4481

ContentsEditorial Awarding ethical innovation in pharma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Events Forthcoming events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 CPhI Worldwide returns to Frankfurt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Scent and artificial intelligence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 K 2019: A world of pioneers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 in-cosmetics North America returns to New York . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 The future of the pharma industry, from those who will deliver it . . . . . . . . . . . . . . . . . . . . . . 12Industry News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Pharmaceuticals The growth of green chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Organic synthesis in pharma. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Changing the shape of GMP peptide manufacture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 The impact of preformulation on successful drug development . . . . . . . . . . . . . . . . . . . . . . . . 26 The data integrity conundrum between pharma and excipients . . . . . . . . . . . . . . . . . . . . . . . . 28Fragrances Odour objects – progress in understanding how we smell . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Scents and self-driving cars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Fragrance regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Cosmetics & Personal Care Targeting the skin microbiome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 The macro-trend of clean beauty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Plastics & Polymers Material opportunities for bioplastics in packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Advancing bio-based chemicals and fuels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 ‘Symphony of Collaboration’ plays a new tune towards sustainability . . . . . . . . . . . . . . . . . . 42Water Treatment Odour control with geo-membrane systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Contract Services Leveraging virtual manufacturing to build secure supply chains . . . . . . . . . . . . . . . . . . . . . . . 46 Managing Asian supply chains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Consolidating while keeping momentum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Digitalization Why digitalization is worth the effort for chemicals operators . . . . . . . . . . . . . . . . . . . . . . . . . 54 Connecting ‘islands in the stream’ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Women in Science Breaking the glass ceiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Driving innovation in a complex world . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Welcome to our October/November magazine, which is partnered with top industry events like CPhI Worldwide, K 2019, in-cosmetics North America, the IFRA UK conference, Pharma Integrates and TIDES Europe. Reflecting these partnerships, this issue offers insights into pharmaceuticals, plastics, cosmetics and fragrances.

As we near the end of our second year of publication, I’d like to thank everyone for their continued support – especially our wonderful sponsors and advertisers, and our editorial contributors. We’ve had some really terrific feedback on the magazine, and I hope you enjoy this issue too.

Don’t forget to stop by to say hello at our partnered events – we love to meet our readers!

Publishing Director Chemicals Knowledge Hub (Global)

2 October/November 2019

www.chemicalsknowledgehub.comEditorial

Sarah Harding, PhDEditorial Director, Chemicals Knowledge

Awarding ethical innovation in pharmaJudges in our first-ever Ethical Innovation Awards are looking for the best and brightest – and most socially responsible – in pharmaceutical innovation.

Every year, the World Health Organization (WHO) identifies the top 10 threats to global health. In 2019, this included environmental and social issues such as climate change and vaccine hesitancy, as well as anti-microbial resistance, dengue, Ebola and other high-threat pathogens, HIV and noncommunicable diseases. More recently, in September this year, the organization announced ‘accelerated efforts’ to eliminate cervical cancer, calling on countries to “expand vaccination, screening, detection and treatment services for everyone, everywhere to address the growing problem of cervical cancer.”

While some of these areas are clearly receiving a huge amount of attention in terms of pharma industry R&D (e.g. it’s going to be a boom year for oncology) there is a worrying lack of investment in other areas, one of the most obvious of those being anti-microbial resistance, which is seeing more than one pharma giant cease R&D in this area due to it being a ‘difficult’ field with limited financial return.

At the same time, our world is struggling with unprecedented environmental challenges. Last year, the Intergovernmental Panel on Climate Change (IPCC) reported that to keep the rise in global temperatures below 1.5°C this century, emissions of carbon dioxide would have to be cut by 45% by 2030. This led to the catchphrase that we had “12 years to save the planet,” and there is no doubt that many organizations – both public and private – are rising to the challenge.

In fact, a lot of companies in the pharmaceutical industry are showing remarkable social responsibility, all the way from their drug manufacturing, through development and to delivery. For example, later in this magazine you will read an article by CatSci’s Joe Renny, explaining how innovative green chemistry can help to improve the sustainability of pharma manufacturing. In the News section of this magazine you will read how Nouryon and van Remmen have joined forces to develop a novel method that addresses the growing

concern of pharmaceutical micropollutants in wastewater, and also about a fantastic collaboration between BioNtech and the Gates Foundation to develop HIV and tuberculosis programs, effectively addressing the call for more R&D in disease areas of high medical need.

These are just a few examples of the many wonderful ongoing projects that demonstrate the industry’s commitment to social responsibility, and here, at Chemicals Knowledge, we believe that those projects deserve to be recognised, celebrated and shared. That’s why Chemicals Knowledge is partnering with CPhI North America for the launch of the Ethical Innovation Awards – to bring together the best of the best in the pharmaceutical industry.

The Ethical Innovation Awards will be taking place during CPhI North America, 5–7 May 2020, in Philadelphia, PA (USA). Nominations for Awards will follow the three tracks of this year’s conference: drug manufacturing, drug development and delivery, and biopharma. Therefore, we will be presenting three awards for:• Ethical innovation in drug development and

delivery• Ethical innovation in drug manufacturing• Ethical innovation in biopharma.

The deadline for entering is Friday 29 March 2020. Entries will be judged by a world-class panel of CPhI judges, who will consider both the social responsibility and originality of the projects submitted for consideration.

To enter your project into the Awards, simply apply on-line at http://chemicalsknowledgehub.com/Awards

I hope you will join us in celebrating the ethical innovation taking place at the heart of the pharma industry.


www.chemicalsknowledgehub.com

For more information about these and other events in the speciality chemicals industry, visit www.chemicalsknowledgehub.com/events

Biopesticides North America9–10 October 2019Orlando, Florida, USAwww.wplgroup.com/aci/event/biopesticides-north-america

IFRA UK Fragrance Forum15 October 2019London, UKwww.ifrauk.org

K 201916–23 October 2019Dusseldorf, Germanywww.k-online.com

Manufacturing Leadership Forum23 October 2019Houston, TX, USA www.manufacturingleadershipforum.com

in-cosmetics North America23–24 October 2019New York, NY, USAnorthamerica.in-cosmetics.com

Munich Adhesives and Finishing Symposium (MKVS) 28–30 October 2019Munich, Germanywww.mkvs.de/en

CPhI Worldwide5–7 November 2019Frankfurt, Germanywww.cphi.com/europe

European Biomass to Power Conference6–7 November 2019Helsinki, Finland www.wplgroup.com/aci/event/european-biomass-to-power

North American Biopolymer Summit 6-7 November 2019Chicago, IL, USA www.wplgroup.com/aci/event/biopolymer-summit-usa

TIDES Europe 12–15 November 2019Amsterdam, Netherlands lifesciences.knect365.com/tides-europe

US Biobased Coatings Summit13–14 November 2019Dallas, TX, USAwww.wplgroup.com/aci/event/us-biobased-coatings-summit

European Thermoplastic Compounding Summit13–14 November 2019Dusseldorf, Germanywww.wplgroup.com/aci/event/the-2019-european-thermoplastic-compounding-summit

Pharma Integrates18–19 November 2019London, UK www.pharma-integrates.com

European Chlor-Alkali Industry Summit4–5 December 2019London, UKwww.wplgroup.com/aci/event/european-chlor-alkali-industry-summit

SOCMA Week4–6 December 2019New Orleans, LO, USAwww.socma.com/socmaweek

Beauty Care Asia Pacific Summit 5–6 December 2019Singaporewww.beautycare-asia.com

Forthcoming EventsEventswww.chemicalsknowledgehub.com


www.chemicalsknowledgehub.comEvents

As the world's largest pharmaceutical exhibition, CPhI Worldwide provides the foremost setting to network and source cost-effective pharma solutions from all over the world – in just three days under just one roof. The exhibition covers the entire pharma supply chain including ingredients, APIs, excipients, finished products, packaging and machinery. Marking another record-breaking year for the exhibition, 2019 sees over 45,000 attendees and 2,500 international exhibitors.

Co-located sub-events In addition to the pharmaceutical ingredients halls, attendees will have access to a number of co-located events throughout the weekend, providing further opportunity to locate exhibitors and easily meet their business needs. • CPhI unites pharma ingredients manufacturers, suppliers and buyers

in the following zones, ranging from APIs, pharmaceuticals, custom manufacturing and excipients to fine chemicals & intermediates and natural extracts.

• P-MEC provides the only European platform to focus on pharmaceutical machinery this year. It is dedicated to pharmaceutical equipment and provides access to latest testing technology and pharma machinery. Additionally, the event will look at underlying conditions driving growth and altering the types of equipment in the market.

• InnoPack brings together pharmaceutical packaging & drug delivery systems, uniting buyers and suppliers from the packaging and pharmaceutical industries. Exhibitors will highlight global packaging solutions in addition to the latest innovations and products in the industry.

• ICSE is a platform that connects outsourcing providers, manufacturers and service experts from across the pharmaceuticals industry. It attracts exhibitors from logistics & cold chain, bio services, (pre)

clinical trials, CRO, clinical data management, analytical and lab services and CDMOs.

• Finished Dosage Formulation (FDF) brings together companies involved in every aspect of the finished dosage supply chain, from big pharma and CMOs to in/out licensing and dossier specialists, end-product distributors and end-user agents. From powders and pills to capsules and creams, visitors will find their finished formulations at FDF.

• BioProduction Congress focuses on bioprocessing and biomanufacturing and is the first year in which the event will be co-located at CPhI Worldwide. BioProduction is an excellent opportunity to increase company profiles, launching new products and expanding business development opportunities. The entire spectrum of biopharmaceutical development and production will be represented at the event.

Extras and additional featuresThe free-to-attend Pharma Insight Briefings will run throughout each of the three Pharma Insight Briefing theatres covering CPhI, ICSE and InnoPack/P-MEC industries – spanning some 60+ seminars.

Two new podiums will be introduced this year: Natural Extracts and World of Pharma, providing two days of discussions and debate.• Natural Extracts will cover global trends across nutraceuticals, natural

ingredients and holistic health, with in-depth sessions running across Tuesday and Wednesday.

• World of Pharma will focus on regional trends, market dynamics and regulatory updates for the UK, Africa/Middle East, US, China, India, Korea and Japan. A new feature for 2019, it provides key insights over two days to help grow business in new markets.

The Innovation Gallery will highlight particularly interesting and innovative products and solutions – providing an opportunity to discover novel pharmaceutical developments in packaging and drug delivery solutions.

The Women in Leadership Forum (Wednesday 6 November at the Frankfurt Marriott Hotel – directly opposite the main entrance) will take place for the 6th consecutive year (15:30-18:30). In an industry dominated by men, the forum provides a platform for debate and to exchange experiences.

M&A Forum will take place on Wednesday (15:30-17:30) in Hall 4, and will explore how small companies will be affected and what the practical implications of the M&A process are.

Finally, the CPhI Pharma Awards have been recognising innovation in the Pharmaceutical industry since 2003. There are 12 award categories open to all Pharmaceutical and Bio-pharmaceutical companies engaged in the design, development, manufacture and distribution of large and small molecule drug products.

CPhI Worldwide returns to FrankfurtCPhI Worldwide will return for its 30th year on 5–7 November at Messe Frankfurt in Frankfurt, Germany. The event unites the pharma industry, with six events covering all aspects of the supply chain – from ingredients and FDF to machinery, packaging, outsourcing and biopharmaceuticals.

For more information, visit https://www.cphi.com/europe

30 years of uniting the entire Pharma value chainThe world’s largest pharmaceutical exhibition, CPhI Worldwide houses six zones

representing each stage of the pharmaceutical supply chain - from APIs, machinery, finished formulations and packaging to outsourcing and biopharmaceuticals.

Uniting over 2,500 international exhibitors, CPhI Worldwide is the place to network and source cost effective pharma solutions from all over the world - in just 3 days, under one roof.

REGISTER NOW! VISIT GOTOCPHI.COM/REGISTER

165+Countries

Participating

100Hours of Free

On-site Content

2,500+Exhibiting

Companies

Meet, network & learn

Everybody here is seriously doing business, looking for business contacts and actively engaging”

Juan Sarmiento, Nemera“



30 years of uniting the entire Pharma value chainThe world’s largest pharmaceutical exhibition, CPhI Worldwide houses six zones

representing each stage of the pharmaceutical supply chain - from APIs, machinery, finished formulations and packaging to outsourcing and biopharmaceuticals.

Uniting over 2,500 international exhibitors, CPhI Worldwide is the place to network and source cost effective pharma solutions from all over the world - in just 3 days, under one roof.

REGISTER NOW! VISIT GOTOCPHI.COM/REGISTER

165+Countries

Participating

100Hours of Free

On-site Content

2,500+Exhibiting

Companies

Meet, network & learn

Everybody here is seriously doing business, looking for business contacts and actively engaging”

Juan Sarmiento, Nemera“



Scent and artificial intelligence The IFRA UK Fragrance Forum 2019 takes place on Tuesday 15th October at the Wellcome Collection in London.

We live in a fast-paced world and great strides are being made in the use of artificial intelligence and machine learning in the fragrance industry, bringing about a quiet revolution in the way we work.

That is why this year’s Fragrance Forum, organized by IFRA UK, has chosen scent and artificial intelligence as its theme - exploring how new technologies are changing the face of the fragrance industry. IFRA UK is a trade body that promotes the safe use and enjoyment of fragrance through its member companies. It stages this annual event as it provides an important opportunity for those in the fragrance sector to come together to learn the latest research and share knowledge.

The event will bring together speakers from a range of backgrounds and we are delighted to have two speakers joining us from the USA this year.

The first is Alex Wiltschko, a Senior Research Scientist at Google Brain where he leads an olfaction-focused machine learning team. His talk will give an overview of what artificial intelligence and machine learning are and how they are used at Google. He will also look at how machine learning can potentially impact fragrance chemistry.

Also joining us from the States is Josh Silverman, CEO of biotechnology and data science company Aromyx. Aromyx is a biotechnology and data science company, which uses biology to capture, identify, and report odour sensory data from the environment. Olfactory receptors have evolved over millennia to bind specific, yet similar, scent molecules and transmit vital information about whether a substance is pleasant, toxic, or anything in between. Using its bio-engineering expertise Aromyx uses olfactory receptors from humans and other

mammals to develop a new way of selecting over a trillion ordorant molecules in complex environments.

This is important as smell impacts many consumer products and industrial processes, and the biochemical basis of an aroma has many uses. It indicates product design and quality, agricultural product attractiveness and identifies whether a product has spoilt or not - to name a few. Josh will be explaining how Aromyx has developed new technology capable of solving diverse sensory problems across a range of industrial processes and products.

We will also be hearing from global fragrance and flavour house Givaudan and how they are applying artificial intelligence to fragrance creation. This is an opportunity to hear first-hand from a company using this technology at the heart or their business.

Other fascinating talks will include looking at lessons we can learn from the olfactory system of insects, to scents and self-drive cars and research that is being undertaken to see if introducing fragrance can they make them safer. These two talks are explored in greater depth in this issue by our two speakers, Professor Thomas Nowotny and Dmitrijs Dmitrenko, both from the University of Sussex.

The day will be rounded off with a panel discussion with all speakers, kindly chaired by features editor of New Scientist magazine, Alison George.

We do hope you can join us and for further information and to book tickets visit http://ifrauk2019.evenium.net/

SAFETY

INSIDETrust our safety expertiseWe combine ingenious products and packaging solutions with individual support to keep you safe, simplify your lab work, and help you save resources. Discover daily safety, risk prevention and emergency solutions that match your high standards. Tools & products for your

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© 2019 Merck KGaA, Darmstadt, Germany and its affiliates. All Rights Reserved. Merck, the vibrant M, and Supelco are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources.

The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.

SAFETY

INSIDETrust our safety expertiseWe combine ingenious products and packaging solutions with individual support to keep you safe, simplify your lab work, and help you save resources. Discover daily safety, risk prevention and emergency solutions that match your high standards. Tools & products for your

Daily safety

Integrated safety right from the start

Risk prevention

Swift, simple and efficient

Emergency helpDiscover more:SigmaAldrich.com/lab-safety

© 2019 Merck KGaA, Darmstadt, Germany and its affiliates. All Rights Reserved. Merck, the vibrant M, and Supelco are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources.

The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.



K 2019: A world of pioneers K 2019 – the world’s No.1 trade fair for plastics and rubber – is opening its gates from 16th to 23rd October in Düsseldorf, Germany.

In the future, economic success will increasingly hinge on the successful fusion of the digital world with the worlds of production processes and product development pipelines. This calls for a creative pioneering spirit. The broad spectrum of K 2019 provides the globally unique level of quality and diversity that form the basis of this most important business platform.

K was first organized by Messe Düsseldorf in 1953 and takes place every three years. The last K in 2016 saw 3293 exhibitors from 61 countries on more than 173,000 m² of net exhibition space and 232,053 trade visitors. This year’s fair is fully booked, again with over 3,000 exhibitors from 60 nations. K will occupy the entire Düsseldorf exhibition grounds with some 175,000 m² of net exhibition space, and more than 200,000 trade visitors from all over the world are expected to come to the event.

K is the performance barometer for the entire industry and its global marketplace for innovations. For eight days, the “Who’s Who” of the entire plastics and rubber world will meet here to demonstrate the industry’s capabilities, discuss current trends and set the course for the future. K 2019 underscores its special position not only through its popularity with the global industry but also by addressing the current challenges of our era and especially of its sector, first and foremost with regard to “plastics for sustainable development” and the “circular economy”. These not only

will be among the hot topics touched on at the exhibitors’ stands at the upcoming K but will also be covered comprehensively in the supporting programme.

For example, the special exhibition Plastics Shape the Future also sees itself as a podium for solutions and answers to current social trends and discussions. Crucial topics will be discussed in detail, including packaging waste, marine litter and climate change on the one hand and resource conservation, energy efficiency and recycling on the other. Plastics Shape the Future not only will offer an international information and networking platform but will also provide for greater involvement of policymakers and socially relevant groups in the form of keynote speeches and speed talks.

The Science Campus of K 2019 offers an opportunity for dialogue between science and industry, with sustainability and recycling management also being examined intensively. Last but not least, the joint appearance of the VDMA (German Engineering Federation) and its member companies will also be focused this time on the topic of the circular economy.For further information please visit www.k-online.de

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The most interactive event in North America for personal care ingredients

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in-cosmetics North America returns to New York revealing the latest insights and innovation Attendees are invited to explore free-to-attend education programs, to gain insight into new product development, the latest ingredients and consumer trends and take advantage of opportunities for collaboration.

in-cosmetics North America – the region’s most interactive exhibition for personal care ingredients and NPD returns to New York from 23–24 October. The show offers R&D professionals, cosmetic chemists, indie brand owners and marketers inspiration for their next cosmetic creation. From connecting with international suppliers, to sourcing the latest innovative ingredients, and gaining expert industry insights, there is something new to be discovered by all.

The show’s renowned educational program returns with a leading line-up of industry experts discussing the hottest consumer and market trends influencing the next wave of personal care products. Topics range from designing the future of cosmetics based on macro-trend influences, to skincare consumer trends.

One of the biggest trends in North America is CBD. The global CBD skincare market is expected to increase by 33% CAGR between 2019 and 2027.1 This trend will be explored in the Marketing Trends Theater, as Adam Miron, Co-founder and Chief Brand Officer at HEXO, addresses What is driving consumer interest in the CBD-cosmetics space. Elsewhere, Denise Herich, Co-Founder and Managing Partner of The Benchmarking Company, will look at US Consumer behaviours, reviewing skincare trends based on focused customer intelligence and feedback. With the FDA introducing new regulations earlier this year,2 David Tyrrell, Global Skincare Analyst at Mintel, tackles Suncare reinvented.

In an in-cosmetics North America first, Dr Claudia Aguirre, Neuroscientist and Mind-Body Expert, examines Make-up your mind: emotions and cognition in the age of virtual beauty. Also taking to the stage are the show’s advisors, Cherie Buziak, CEO/Owner of BeautyEdge, who will tackle Expressive beauty without boundaries, and Karen Young, CEO of The Young Group, who discusses Beauty and clean living – how is the cosmetics industry adapting to this trend?

The ever-popular Technical Seminars will explore practical and technical elements of new product development. Tapping into demand for natural products, Brittany Pease, Applications Chemist at INOLEX (Univar Solutions), will speak about Formulating high performance natural products. While Annika Leschner, Senior Global Sales and Marketing Manager Cosmetics & Personal Care at bitop, will discuss Blue light, pollution and UV.

For first-hand experience in creating winning formulations, the free, interactive Formulation Lab returns, hosted by the show’s new official technical advisor Mark Chandler. Sessions include Serum submersion with Josey Casto, Cosmetic Application Chemist at EMD Performance Materials.

The Formulation Challenge returns to showcase the complete NPD process, giving leading manufacturers the chance to battle it out for this year’s title. Mark Chandler will set this year’s challenge and select the winning product formulation alongside returning judge, Sarah Jindal.

The popular Innovation Zone – sponsored by Mibelle Biochemistry – will showcase innovative raw materials, launched within the last eight

months. Visitors can test product effectiveness at the formulation displays and gain inspiration. The zone will also host Mintel Live Demonstrations, offering the chance to interact with some of the world's most innovative personal care products.

Presenting some of the biggest innovators in the field, the Sensory and Make-up Bar returns with a brand-new partnership with Peclers Paris, who will highlight two key beauty trends to watch. In two 30-minute presentations Psyche Tech – how science and nature can aid innovation and encourage progress – and Origins – exploring Oceania as the home of fascinating cultures and traditions, will be put under the spotlight.

Attendees will also get the unrivalled opportunity to meet international suppliers from all stages of the NPD value chain, helping them meet their business needs. Global providers of specialty materials and ingredients in skincare, suncare and haircare will showcase their products, including Grant Industries. with its portfolio of high-performance materials including its new SiApp elastomer gels based on plant-based alkanes. Equipforski will display its range of tripeptides, including Winhibin for whitening, anti-ageing and brightening.

Helping attendees navigate texture in their formulations, Sekisui Plastics will showcase two specialist products: TECHPOLYMER TM and ST gel TM - facial mask products. In addition, Interpolymer will display its SYNTRAN film forming polymers.

Advisor to the show, Cherie Buziak, CEO/Owner of BeautyEdge, will showcase the best innovations during the Fast Track Marketing: Technology Tours. Whilst the new Indie Trail and Tour will provide indie brands with the support they need to identify and meet suppliers who can offer ingredients to suit a smaller scale production.

in-cosmetics North America Event Director, Daniel Zanetti, commented “With such an exciting and diverse program of features, speakers, tours and suppliers, I couldn’t be more excited to open the doors to in-cosmetics North America this October. There has never been a more pertinent time for industry professionals and brands of all sizes to take the opportunity to learn, network and sample the latest ingredients, products and services that the market has to offer.”

References1. www.futuremarketinsights.com/reports/cbd-skin-care-market2. www.fda.gov/news-events/press-announcements/fda-advances-new-proposed-

regulation-make-sure-sunscreens-are-safe-and-effective

Events

in-cosmetics North America will take place at the Javits Center in New York from 23–24 October 2019. For more information, please visit http://northamerica.in-cosmetics.com



Organised by:

Where personal care ingredientsand creators come together

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Now in its 8th year, Pharma Integrates is a world-renowned conference which brings together senior executives from across the pharma, biotech, CROs/CDMOs, investment and regulation landscape to examine the drivers and hurdles of today, and resolve the critical business issues of tomorrow.

The conference will take place on 18th and 19th November 2019 at the Leonardo Royal Hotel London Tower Bridge, only a few minutes’ walk away from the infamous sights of the Tower of London and London Bridge.

The conference will play host to an unrivalled line up of speakers including:• Haseeb Ahmad, President of the Association of the British

Pharmaceutical Industry (ABPI) and Managing Director UK, Ireland & Nordics, Pharmaceuticals and Country President UK of Novartis Pharmaceuticals.

• Sir Andrew Witty, CEO of Optum and former GEO of GlaxoSmithKline.• Menelas (Mene) Pangalos, Executive Vice President,

BioPharmaceuticals R&D, AstraZeneca

Through the key themes of Tactics, Technology and Treatment, we will discuss how strategies can be employed to drive innovation and use novel science or tech approaches to meet the growing healthcare needs of the global population. Some of our sessions will include the following presentations.

Tactics• Positioning for growth in turbulent times. With global political

uncertainty and ongoing scrutiny on pharmaceutical pricing and practices, the industry is facing several headwinds. However, technological advances and the increasing power of the patient voice present the opportunity of different business models and greater

collaboration between academia, healthcare industry and the patient. How are companies navigating this shift?

• Boosting innovation via strategic relationships: What will it take to advance strategic relationships across the value chain (for example, between CDMOs, CROs, large pharma companies and academia) beyond politics to increase innovation? Perhaps incentives, a different platform of interaction and equity will mark the way forward.

Technology• Love it or loathe it, ‘Big Data’ is everywhere: Whether data are

generated from high-throughput screening, process monitoring, continuous manufacturing, or from patients, we need effective methods to collect and use these vast quantities of data. How do we go from being data rich and information poor to maximizing the value of our data? How do we turn data into insight ….and ultimately improved health outcomes?

• Is AI the future of healthcare? Will it deliver on its promise of being the future of everything from drug discovery to patient compliance and anti-counterfeiting?

Treatment• Population health vs personalized medicine. How can we deliver health

solutions for the general population yet at the same time ensure each patient has a personalized experience?

• Getting advanced therapies to patients – fast! From skills to supply chains, how can we ensure advanced therapies get to patients rapidly?

For more information and to register please visit www.lifescienceintegrates.com/pharma-integrates

Events

The future of the pharma industry, from those who will deliver itLife Science Integrates welcomes you to this year’s Pharma Integrates conference in London from 18–19 November.

visit azelis.com/canada I chemroy.com

With the acquisition of Chemroy, we proudly take our place as the #1 Canadian distributor of specialty chemicals and food ingredients.

Azelis Canada has been a market leader, founded on technical and marketing excellence in the Personal Care, Pharmaceutical, CASE, and Essential Chemicals segments. We are pleased to build on that foundation by adding the products, capabilities and expertise of Chemroy; including our three application labs (CASE, Pharma and Food). We will now be able to provide more solutions and product selection for our customers in the CASE, Food, Pharma, Lubes, and Nutraceutical industries.

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www.chemicalsknowledgehub.comIndustry News

Mergers & Acquisitions Givaudan, the global leader in flavours and fragrances, has completed the acquisition of Drom, a perfume house headquartered in Germany and with manufacturing facilities in China, the USA and Brazil.

France’s Anjac Health & Beauty has purchased California-based Cosmetix West, increasing its presence in the US and allowing Anjac to expand in several growth markets, including Clean Beauty.

SWK Holdings Corporation, a life-science speciality finance company, has acquired Enteris BioPharma, a company specializing in oral peptide drug-delivery technology, for $21.5 million

Pharmaceutical and biotech product development consultancy Boyds has enhanced its clinical and medical affairs services offering following the acquisition of Blue Duck Consulting.

Indicia Production, a CMO specializing in the manufacture of microbiological media and sterile pharmaceutical ingredients, has acquired Bio-Steril, which specializes in the formulation and Fill & Finish of medical devices for cosmetic and medical uses.

Wacker Chemie is intensifying its research activities on silicon-based materials for high-performance batteries by acquiring a 25% stake in Nexeon, a company that develops and produces silicon-based anode materials that enhance the performance of lithium-ion batteries.

BASF and the fine chemical company DIC have reached an agreement on the acquisition of BASF’s global pigments business, for a price of €1.15 billion.

Vertex Pharmaceuticals has entered into a definitive agreement to acquire Semma Therapeutics, a biotechnology company pioneering the use of stem cell-derived human islets as a potentially curative treatment for type 1 diabetes, for $950 million.

GlaxoSmithKline (GSK) has agreed to acquire Sitari Pharmaceuticals, a company developing treatments for celiac disease, from Avalon Ventures, a venture-capital firm.

Catalent to open new clinical supply facility Catalent is to invest $9 million in a new clinical supply facility in San Diego, CA (USA). The new 24,257 square-feet facility will offer full clinical supply services to pharmaceutical and biopharmaceutical customers and will specialize in services for early-phase clinical trials. It is due to open in the summer of 2020.

Its capabilities will include clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and drug returns and destruction, and will include stability chambers.

“This investment supports Catalent’s commitment to offering customers greater flexibility and expanded support for early-phase studies,” commented Paul Hegwood, President, Clinical Supply Services. “The facility will allow Catalent to provide superior clinical services throughout the western corridor of the US and Canada’s drug development region.”

Thermo Fisher advances precision medicine with Lilly Oncology Thermo Fisher Scientific has announced an agreement with Eli Lilly and Company for the development of a companion diagnostic that will use the US FDA-approved, next-generation sequencing-based Oncomine Dx Target Test to identify certain non-small cell lung cancer and thyroid cancer patients who may be treated with Lilly's investigational therapy, LOXO-292.

"One of the biggest barriers to realising the full power of precision medicine in oncology is having access to high-quality testing, such as next-generation sequencing-based tests, that identify a broad range of clinically actionable alterations, can be performed locally and allow treating institutions to participate in this important step in the evolving treatment paradigm," said Anne White, President of Lilly Oncology.

The new test would be used with patients whose tumours harbour a ‘rearranged during transfection’ (RET) alteration. RET variants are found in about 2% of NSCLC, about 60% of medullary thyroid cancer and up to 20% of other thyroid cancers.

ReAgent launches biological reagent manufacturing serviceReAgent Chemical Services has successfully achieved ISO 13485 accreditation, which demonstrates that they meet the rigorous requirements of a quality management system specific to the medical devices industry. Alongside this accreditation, ReAgent has launched a new biological reagent manufacturing service supplying bespoke reagents, including biological buffers, bioprocessing reagents, and in vitro diagnostic reagents.

Richard Hudson, ReAgent’s CEO, said “Gaining ISO 13485 accreditation is a great achievement for ReAgent. It shows our high-quality standards, provides credibility to our customers, and adds another string to our bow. I’m very proud of the team, who are committed to making ReAgent the best it can be for our customers.”

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SternLife debuts with clinical nutrition concepts SternLife, a renowned supplier of private label functional foods, will exhibit at CPhI Worldwide for the first time this year. The company will showcase a portfolio of supplementary and nutritionally complete medical foods for the prevention of malnourishment. Ideal for nutritional therapies in hospitals, care homes and other medical facilities, the portfolio includes bars, powders and thickening agents.

“As an experienced partner for innovative clinical nutrition products, we support our customers from the very first idea,” explained Antje Wetzel, Head of Product Development at SternLife. “We develop tailor-made formulations and produce products at our state-of-the-art facilities in Germany, where the highest standards are met.”

BioNtech collaborates with Gates Foundation on HIV and TBBioNTech has signed an agreement with the Bill & Melinda Gates Foundation to develop HIV and tuberculosis programs. The partnership includes an initial equity investment of $55 million, to develop preclinical vaccine and immunotherapy candidates to prevent HIV and tuberculosis infection as well as to lead to durable antiretroviral therapy-free remission of HIV disease. Total funding could reach $100 million through potential future grant funding from the Gates Foundation that would be used to underwrite the evaluation of these candidates and support new infectious disease projects.

“We are thrilled about the partnership with the Gates Foundation and the outstanding network of infectious disease specialists that it has built,” said Professor Ugur Sahin, CEO of BioNTech. “Targeting severe infectious diseases such as tuberculosis and HIV infection is in line with our mission to leverage our immunotherapy capabilities not only for cancer but also beyond, in disease areas of high medical need.”

Nouryon and Van Remmen clean up pharma wastewater Nouryon has joined forces with water treatment company Van Remmen UV Technology on a novel method to address the growing concern of pharmaceutical micropollutants in wastewater. The process, which combines the Advanox ultraviolet (UV) treatment process from Van Remmen UV Technology and Nouryon’s MicrOx hydrogen peroxide, is expected to remove more than 90% of pharmaceutical residues.

“Growing global pharmaceutical use is creating a significant pollution problem for urban wastewater treatment systems,” said Niek Stapel, Managing Director Pulp and Performance Chemicals at Nouryon. “With this advanced water treatment concept, customers in the water treatment market will have access to two proven technologies that together enable measurement, monitoring and means to control micropollutants in wastewater streams.”

FDA seeks input on generic drug developmentThe FDA has published 54 product-specific guidances, including 42 new and 12 revised guidances that, when finalized, will describe the Agency's thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. Twelve of the new draft guidances and six of the revised guidances are for complex drug products, including multiple products that don't yet have generic competition. The FDA seeks feedback and will consider all comments before it begins work on the final versions of these documents.

The FDA believes that increased transparency on product-specific guidances gives applicants seeking to develop generic drugs a better opportunity to allocate resources. The agency aims to ensure that policies and regulations – and scientific standards – keep pace with the science of equivalence. Improving patient access to high quality and affordable medicines supports the FDA's mission to advance public health.

ARLANXEO spotlights new mobility solutions ARLANXEO participates in its second K fair under the theme Future Mobility, as trends like electrification and autonomous driving look set to fundamentally change transportation in the next decade.

Trends for alternative ways of mobility sharing and usage as well as new kinds of energy generation and storage, are responding to the need of more sustainable and responsible mobility. Those trends are met with new demands for solutions from the synthetic elastomer industry, requiring new materials with lighter weight, better thermal characteristics, reduced noise, optimal vibration performance and lower energy consumption. ARLANXEO is putting its full focus on addressing these requirements.

Donald Chen, CEO of ARLANXEO, said "Our high-end rubber solutions are a key enabler of new technologies needed to make future mobility a reality. With innovation as essential part of ARLANXEO’s success and strategy, we are working closely with our customers in meeting their needs in electrification and automation. This year´s K fair presents a great opportunity to showcase our offerings and further explore cooperation opportunities with our clients and partners in the automotive and transportation industry."


www.chemicalsknowledgehub.com Industry News

Covestro launches technology for CO2 in plastics production A team from Covestro and RWTH Aachen University has reached the finals for the German Future Prize with a new process for using CO2 as a raw material. The prestigious award will be presented by Federal President Frank-Walter Steinmeier on 27th November in Berlin. Dr Christoph Gürtler and Dr Berit Stange from Covestro, as well as Professor Walter Leitner from RWTH Aachen University, are hoping for a victory. They have been instrumental in the development and market launch of a technology for using CO2 exhaust gas in plastics production.

The CO2 can be used for a wide range of high-quality plastics (polyurethanes). The process makes a contribution to sustainability and resource conservation by partially replacing the conventional raw material crude oil with CO2 as a carbon supplier.

"We see considerable value creation potential for industry in the use of CO2," said Gürtler, who is responsible at Covestro for the development of new processes and products.

“As alternative carbon sources, CO2 as well as plants and plastic waste have the potential to revolutionize production in the plastics industry," stressed Covestro CEO Dr Markus Steilemann. "Covestro is a pioneer in this field. Fossil raw materials such as oil can no longer be the main resource of our industry if the world embarks on a more sustainable future."

Brenntag expands distribution agreement with BASFBrenntag Specialties, part of the Brenntag Group, the global market leader in chemical distribution, will become the exclusive distributor for BASF's amine curing agents in the Western and Southwestern United States, effective 15th October 2019.

The Baxxodur amine product line, including Polyetheramine (PEA) and Isophroediamine (IDPA), is composed of prepolymers, curing agents and chain extenders. They can be used in many applications such as epoxy, polyurethane and polyurea coatings, adhesives, sealants and flooring. Primarily manufactured in Ludwigshafen, Germany, these curing agents differ in molecular structure, basicity, and in the type and number of their functional groups. This difference helps to control the curing reactions and the properties of the cured thermosets.

“This collaboration provides our customers the convenience of developing and sourcing their entire formula from one source,” said Ted Davlantes, Vice President, Coatings & Construction, Brenntag North America. “In addition, customers are fully supported with a dedicated team of industry experts and a broadened product portfolio.”

LANXESS expands technical customer services LANXESS has added to its technical services for pigment customers, with its Inorganic Pigments (IPG) business unit expanding the technical centre at its biggest site in Krefeld-Uerdingen, Germany. The facility is now equipped to carry out automated measurements of thermal stability in customer-specific plastics applications.

“From sample-loading to colourimetric analysis, all the necessary modules can be actuated via automated processes. That allows us to carry out highly specific tests with supreme accuracy,” said Stefano Bartolucci, Global Market Segment Manager for Plastics at IPG.

At K 2019, the company will be presenting its comprehensive range of Colortherm inorganic pigments for colouring plastics.

“Our range of products includes both all-rounders and specialists aimed at specific requirements. Thermal stability, colour strength, resistance to light and weather, and chroma all determine the property profile, depending on the product in question,” explained Bartolucci.

People Arcinova, a multi-service CDMO based in the UK, has appointed Roger Kilburn as its new CEO. The current CEO, Ian Shott, moves to the position of Executive Chairman. The changes further strengthen Arcinova’s executive management team as it continues its growth and maturation.

L’Oreal USA has announced the appointment of Ali Goldstein as President, effective October 1, 2019.

Stora Enso’s Board of Directors has appointed Annica Bresky as the new President and CEO of the company as of 1 December 2019.

Mogrify, a UK company aiming to transform the development of cell therapies, has appointed Dr Jane Osbourn, OBE as Chair of the Board. Dr Osbourn will also join the Scientific Advisory Board, and support the executive team in program selection, partner development, mentoring and investor relations.

Nanoform, an innovative medicine enabling nanotechnology company, has strengthened its Board with the appointment of Mads Laustsen as a non-executive member. The company has also appointed Mike Rea as Strategic Innovation Advisor, with the goal of maximizing the value of Nanoform’s proprietary nanonization technology for pharmaceutical partners.

Boyds, a consultancy business that supports the development of pharmaceutical and biotech products, has recruited Consultant Pharmaceutical Physician, Susan Tansey. She will add strength and depth to the company’s clinical trials offering, as well as helping to drive plans for continued growth.

Azelis has appointed Ron Rosenberg as Group Technical Innovation Director. This appointment reinforces Azelis’ focus on application and formulation support, and its ambition to become the benchmark as a fully integrated and innovative solutions provider.

CatSci, a process research and development CRO, is furthering its global growth strategy with a new Head of Business Development for North America. Dr Jas Douville’s overall aim is to help deliver affordable, best-in-class small molecule therapeutics to meet the evolving healthcare needs of the world.



The EthicalInnovation

Awards 2020

6 May 2020Philadelphia, PA, USA

Pennsylvania Convention Centre

General enquiries: [email protected]

Sponsorship enquiries: Ellie Bruni | [email protected]

Ken Carroll | [email protected] Scanlan | [email protected]

EIA2020_A4_CMYK.indd 2 09/10/2019 16:17

Evonik breaks ground for new polyamide 12 complexEvonik has begun construction of its €400 million complex at Marl Chemical Park in Germany. With this development, the company is expanding capacity for polyamide 12 (PA 12) by more than 50%. Startup is scheduled for 2021.

Christian Kullmann, Chairman of Evonik’s Executive Board, said “We’re building this plant because we want to continue to grow with innovative specialty chemical products. With our high-performance polymer PA 12 we can supply global strategic growth markets such as 3D printing. But also in the automotive industry, our light-weight and long-lasting plastic makes an important contribution to resource efficiency.”

Evonik has spent years developing specialty polymer powders that allow manufacturers to use 3D printing to produce high-tech components on an industrial scale. The company is one of the world’s leading producers of PA 12, for which there is considerable demand in markets such as the automotive industry, oil and gas extraction, medicine and athletics. A powdered version is also used in applications such as metal coatings for consumer goods, automobile components and medical devices.

Givaudan launches natural alternative to cationic guar for hair conditioning Givaudan Active Beauty presented Naturein Wheat Peptides, a clean and sustainable alternative to cationic guar, a key specific detangling ingredient for hair care, at in-cosmetics Latin America 2019. The new natural ingredient is obtained from 100% French origin locally-sourced wheat, and it is crafted by green fractionation.

Ecological and natural beauty are two of the biggest hair care market trends. By being 100% natural and crafted in one of the most important French farming regions in a Biorefinery platform, Naturein Wheat Peptides delivers a clean product that is not only good for the consumer, but also for the environment. As an alternative to cationic guar, it acts as a conditioner to smooth and detangle the hair.

Amandine Scandolera, Head of Biological Evaluation, said “Cationic guar is the most used chemical ingredient in the hair care market. To prove the effectiveness of our natural asset, we opted for tests that put Naturein Wheat Peptides in competition with cationic guar. Results prove that it is more effective in record time. All clinical tests carried out on a hundred people demonstrate the excellence of Naturein Wheat Peptides.”

First 3D bioprinted human reconstructed skin Cooperation partners BASF Care Creations and CTIBiotech have announced the development of the first 3D bioprinted skin models including immune macrophages. The reconstructed tissue models will be the basis for development and testing of bio-actives for skin care applications. The technology will provide a powerful platform for skin care researchers wishing to study the function of macrophages (which have a high degree of plasticity that promote or suppress inflammation) in a fully reconstructed skin.

“Compared to current in vitro methods, the 3D immune bioprinted skin developed with CTIBiotech will allow analysis more in line with human physiology and the immune role of macrophages,” said Dr Sébastien Cadau, 3D tissue engineering specialist at BASF site in Lyon, France. “That’s how the technology is going to help us accelerate the development of innovative and highly reliable ingredients for the skin care market. Our understanding of an immunocompetent 3D skin provides the basis for developing and testing advanced cosmetic bio-actives for skincare applications.”

BASF publishes 3rd Palm Progress ReportBASF has launched the third edition of its palm progress report (PPR) featuring figures for 2018. One of BASF’s key renewable raw materials is palm kernel oil and its primary derivatives, which are mainly used for the production of ingredients for the cosmetics, detergent and cleaner industries, as well as human nutrition.

The company is a member of the Roundtable on Sustainable Palm Oil (RSPO). During the past year, the company purchased 127,000 metric tons of certified sustainable palm kernel oil. This represents around 70% of the company’s total volume – an important step towards its commitment to source only RSPO-certified sustainable palm oil by the end of 2020.

Compared to conventional sourcing, the company saves more than 200,000 metric tons CO2 by sourcing certified sustainable palm kernel oil. The report also mentions the dilemmas in oil palm plantation development, and features the company’s palm commitment, its palm sourcing policy, and its approach to include smallholder farmers.

BASF took the decision to drive sustainable palm with a major portfolio shift in 2018. The company offers palm-based ingredients for the personal care market that are RSPO-certified as sustainable. This is an important milestone for the cosmetics industry. In addition, BASF has increased its certified production sites to 23 globally in 2018.

Casting light on assessment of cosmetic activesThanks to its patented XPolar technology, Kamax Innovative is bringing a new dimension to optical observations of cosmetic active performance. Using polarization to record contrasts and differences in the activity of a cosmetic product on the skin or hair, the novel technology can read contrast differences and quantify biological modifications on dermal collagen and hair keratin.

“We accurately monitor dermal collagen and measure the direct effects of stress factors, like UV rays or oxidation, which can appear on in vitro skin, or the chemical impact of colourants, for example hair colourants,” explains Jérôme Desroches, President and Founder of Kamax Innovative. “We observe a natural XPolar signature made possible thanks to light and demonstrate the activity of products in cosmetics without any particular sample preparation. In addition, our technique helps discover previously unknown actions. It goes beyond the standard technique.”

The EthicalInnovation

Awards 2020

6 May 2020Philadelphia, PA, USA

Pennsylvania Convention Centre

General enquiries: [email protected]

Sponsorship enquiries: Ellie Bruni | [email protected]

Ken Carroll | [email protected] Scanlan | [email protected]

EIA2020_A4_CMYK.indd 2 09/10/2019 16:17



The term ‘green chemistry’ was popularized in the 1990s under the context of increasing awareness around chemical pollution and resource depletion. The 12 principles of Green Chemistry were defined in 1991, but the processes associated with green chemistry date back much further – good chemistry in manufacturing has long been guided by ensuring processes are as efficient and economical as possible. Important concepts related to green chemistry, such as atom economy and the integration of catalysis, have always played a crucial role in creating efficient chemistry.

An increased pressure for sustainability within industry from regulatory bodies, such as the European Environment Agency (EEA) and the EPA, investors and the general public, means that green chemistry will continue to remain important. Greener manufacturing processes and routes through process chemistry are critical to achieving this. As industry increasingly relies on outsourcing models, pharmaceutical, agrochemical and materials sponsors will continue to utilize the capabilities found in Contract Research Organizations (CROs) to deliver innovative green chemistry solutions.

Pursuing a green pipelineFor a CRO operating in the drug discovery and development field, green process chemistry must reflect the needs of their customers and be perfect for purpose. Tailoring robust green chemistry solutions to each individual project helps to create efficient and sustainable processes with low toxicity and minimal resource depletion. This will be influenced by what is needed in a project at a particular stage, with different factors taking precedence depending on a drug candidate’s progress through development.

Replacing toxic reagents and solvents that are potential thermal hazards with ethically sourced, safer alternatives is an important initial step. A CRO may then start to look at the reliability and scalability of a route, with an assessment of atom economy. Yielding the maximum amount of a desired product with minimal waste is the archetype of green chemistry principles. As the drug moves towards commercialization, it is important to consider the legal ‘freedom to operate’ of any green chemistry technology that has been used. Moreover, financial implications need to be considered in readiness to launch – a process must not be only environmentally sustainable but also commercially viable.

The importance of these processes allied with green chemistry across the drug discovery and development pipeline demonstrate its importance in the speed, quality and cost triangle. A process that has been optimized using green chemistry could be more cost-effective, produce a higher quality end-product and more rapidly produce a product.

The future’s bright, the future’s greenExciting technology is revolutionizing how we are creating these sustainable outputs across the pipeline. Take photocatalysis, which utilizes light to accelerate a reaction under mild conditions by generating reactive intermediates. Contemporary research is combining this technology with transition metal catalysis. This creates profound changes

to reactivity and selectivity, enabling route development through entirely new mechanistic paradigms.

Innovations in flow chemistry are also playing an important role in delivering green solutions. This technology utilizes continuous processing, with benefits including increased reaction efficiency, greater throughput, lower solvent usage and catalyst recycling. One exciting application of flow chemistry is the use of highly reactive compounds such as diazomethane. These compounds can be used in low concentrations to create high throughput of materials using clean reactions.

However, creating robust green chemistry is not without its challenges. One of the biggest tasks for drug developers is to stay abreast of exciting innovations. While flow chemistry and continuous processing are widely used by the bulk chemical sector, the pharmaceutical industry has been slower on the uptake. Proprietary issues also present further obstacles. For example, the issue of patented enzymes in the burgeoning field of biocatalysis can act as a driver for the selection of non-proprietorial solutions when developing a large-scale commercialized process.

Partnering with the right CRO can help to address these obstacles. Extensive expertise in green chemistry approaches, world class facilities and a deep understanding of intellectual property issues helps to reassure customers that green solutions are technically and financially feasible (and often superior) and can be seamlessly implemented. As these green technologies continue to be implemented within the pharmaceutical industry, a framework and model based around monetization will establish itself. This will further catalyse implementation and uptake.

Another challenge faced by drug developers is the perceived complexity of green chemistry. Reducing the volume of waste generated and replacing toxic ingredients mandates a process-wide approach – often requiring the specialized expertise found at a CRO. Service providers must stay at the cutting-edge of research and development to tackle these difficult problems.

A value-adding CRO will always be searching for ways to make its customers’ chemistry greener; an economically sustainable process that can quickly produce results has always been a priority. However, growing awareness about environmental concerns and advances in R&D has led to the exponential growth of green chemistry. It is an exciting time to be working in process chemistry, using green technology to help transform both industry and wider society.

Pharmaceuticals

The growth of green chemistryWith climate change prompting regular calls to improve the sustainability of manufacturing processes used in industry, developing green solutions is now a more pressing issue than ever, says Joe Renny, Senior Scientist at CatSci.

Joe Renny, Senior Scientist at CatSci

Author: Joe Renny, Senior Scientist at CatSci Ltd, CBTC2, Capital Business Park, Wentloog, Cardiff, CF3 2PX, UK T +44 29 2083 7444 E: [email protected]

AD CPhI Cat Inside Front Cover 168x240 0919.indd 1 12/09/19 10:49



Organic chemistry – the study of carbon-containing compounds – was originally limited to compounds produced by living organisms. However, since Robert Burns Woodward received the 1965 Nobel Prize for Chemistry for organic synthesis – the intentional construction of organic compounds – it has developed into one of the most important branches of organic chemistry. Organic synthesis is now used in an enormous range of industry sectors, with recent advances such as late-stage functionalization, new bond-forming techniques, and the intersection of biomolecules with synthetic chemistry, continuing to push the field forward.

We spoke to Dr Fritjof Weidner, Market Manager Advanced Intermediates at Biesterfeld, about the growing demand for intermediates and products for organic synthesis, and the trends and opportunities behind those demands.

Drug discovery and development “Within the chemical industry, the pharmaceutical industry is considered to be the most important customer base for advanced intermediates,” says Dr Weidner. “These are being used to produce Active Pharmaceutical Ingredients (API), which are then formulated with inactive components (excipients), to generate the finished dosage form, sold as a drug product. Of course, advanced intermediates – made by organic synthesis – are not only used to produce active ingredients for human but also for veterinary pharmaceuticals, as well as for agrochemicals and for many other speciality chemical industries.”

However, within the pharmaceutical industry, it is generally agreed that organic synthesis is poised to transform drug discovery. To consider the impact of the science on current drug discovery and development, Dr Weidner provided a quick analysis of newly-approved drugs.

“In 2018 the US Food and Drug Administration (FDA) approved a total of 59 novel drugs and biologics of which 38 drugs were small molecules, made by traditional chemical synthesis, starting from intermediates,” he explains. “The 2018 number 1 top selling drug was the antibody Humira, made by gene synthesis, followed by Lyrica and Eliquis, both being made by chemical synthesis. Therefore, on the basis of only these examples it can be assumed that chemical or organic synthesis still dominates drug synthesis.”

“Drug discovery involves screening for biological activity, definition of lead compounds and design. Chemical synthesis is already involved during the screening process, to synthesize large numbers of different chemicals, to finally select target or lead compounds having sufficient potency and drug properties”, elucidates Dr Weidner. “Once a lead compound has been identified, the drug development process commences with preclinical and clinical trials. In this way, the chemical synthesis or process is optimized for scaling-up from milligrams to kilograms or even tons.”

“So,” he concludes, “organic or chemical synthesis is of crucial importance during the entire drug discovery and development process.”

Process and technology“For fine chemicals and advanced intermediates, chemical synthesis and biotechnology are the most frequently used technologies”, the chemist reveals. However, if just one technology should be highlighted as particularly well-suited for pharmaceuticals, Dr Weidner thinks it would be stereospecific synthesis with chiral catalysts to generate single-enantiomer products.

Organic synthesis typically consists of multiple steps in its process, with intermediates formed at each step of the reaction.

“Organic compounds, or intermediates, are produced either from petrochemical starting materials or from extracts or by means of biotechnology processes,” says Dr Weidner. “The number of chemical steps leading on from the basic, commodity-type starting materials, via fine chemicals or advanced intermediates through to the final product, e.g. pharmaceuticals or any other speciality product, can vary from two to many steps, sometimes even more than twenty.”

“A multitude of chemical reactions, such as nitration, hydrogenation, halogenation, cyclization, palladium-catalysed coupling, and more, can be used for each step,” he continues. “Basic starting material (commodities) are usually produced in large-scale and dedicated plants, whereas fine chemicals or advanced intermediates are produced in multi-purpose plants, by means of multi-step synthesis and in limited quantities, rarely exceeding more than several hundred tons per year.”

Could artificial intelligence (AI) have a potential role in organic synthesis, we wondered.

“Machine-assisted synthesis of biomacromolecules or the use of AI for synthesis planning is a quite specialized field,” replied Dr Weidner. “We are aware of this potential and believe will gain importance in the near future.”

We asked Dr Weidner whether achieving stability of the intermediates was an important factor in reaching the end product.

“I wouldn’t put it quite like that,” he mused. “The stability of any chemical is directly linked to its reactivity and chemical properties, respectively, and appropriate packing and storage. Specific chemicals can be stabilized by adding a stabilizer. Otherwise it would be replaced by utilizing different or more stable compounds, leading to the same end product.”

Clearly, replacing compounds in this way reflects a confident expertise in organic synthesis reaction pathways. This begged the question – how do you choose the optimal route for synthesis of a compound/intermediate?

“The diversity of chemical reactions allows the synthesis of a specific molecule using various routes of synthesis, which is crucial to optimizing

Pharmaceuticals

Organic synthesis in pharmaWe speak to Dr Fritjof Weidner, Market Manager Advanced Intermediates at Biesterfeld Spezialchemie, about the transformation effect of organic synthesis on drug discovery, and how the science is driving demand for organic intermediates and products for pharmaceuticals.

Dr Fritjof Weidner, Market Manager Advanced

Intermediates at Biesterfeld Spezialchemie


www.chemicalsknowledgehub.com Pharmaceuticals

a process in view of patent infringements, economic viability and environmental safety, among other factors,” says Dr Weidner. ”Making the most of our close working relationship with innovative partners and our market expertise and knowledge, we at Biesterfeld can meet current market demands with our flexible product portfolio, which we are able to customize whenever required. We have an in-depth and extensive knowledge of our customers' requirements, and can, therefore, supply the raw materials needed while ensuring the quality, packaging and delivery time demands are met by the application involved.”

RegulationsBiesterfeld offers a wide portfolio of organic and inorganic base chemicals, solvents and intermediates for organic synthesis. Specifically within the organic synthesis portfolio, the company provides fine chemicals and advanced intermediates, such as pyridines and piperidines, phase-transfer catalysts and fluorine compounds, for a wide range of applications and market segments.

“These include industries such as pharmaceuticals, flavours and fragrances, agriculture, polymers and personal care,” says Dr Weidner. “We also develop customer-specific products. Working with our suppliers, we are able to develop a tailored intermediate for each of our customers, to meet their exact needs, and in compliance with requirements such as REACh”.

It is not necessary for all of these products to be REACh registered, he explained, as – for example – there is no obligation to register substances that are produced in amounts below one metric ton per year. However, to comply with the REACh regulations, Biesterfeld has already completed registration for more than 155 materials, of which eight are registered as ‘Full’, and the rest are registered as ‘Intermediates’ in accordance with Article 18. Biesterfeld is currently working on submission dossiers for another 30 materials for registration, to be completed by the end of 2019 or early 2020.

“Our REACh expertise gives our customers real added value and an additional service in the sense of providing reliability for our available products,” adds Dr Weidner.

“However, at present, the market for advanced intermediates used in organic synthesis is being impacted by shortages of raw materials, and simultaneous high demand,” Dr Weidner spotlights.

This, he explains, is because many manufacturers are struggling to comply with new regulatory requirements, such as REACh, and environmental protection regulations – especially in China.

“This is resulting in ever more frequent production stops or even shutdowns,” he explains. “However, we are still able to provide our customers with excellent service, thanks to our close relationships with leading international suppliers, primarily in Asia, fostered by our long-standing collaboration.”

The futureIt is Dr Weidner’s view that organic synthesis was, and will continue to be, the main driver not only in the drug discovery process, but also for many products made and used in the life science industry, as it has proven to be a valuable and successful technique. Consequently, at Biesterfeld this segment of Advanced Intermediates, as part of the HealthCare department, already plays, and will continue to play, an important role.

“We at Biesterfeld believe in innovation and change”, explains Dr Weidner. “As our Managing Director Peter Wilkes always says ‘it’s a marathon, not a race!’ Therefore, we are constantly working to enhance our business processes and the service we offer in order to increase the added value for our customers and suppliers. For example, this not only includes an extensive and innovative product portfolio but also continuing and expanding our consultancy services such as laboratory support, product formulation and beyond. 2020 will be a particularly exciting year for Biesterfeld in this regard.”

Interview with: Dr Fritjof Weidner, Market Manager, Advanced Intermediates, Biesterfeld Spezialchemie, Ferdinandstraße 41, 20095 Hamburg, Germany T: +49 40 32008 349 E: [email protected] www.biesterfeld.com



BackgroundAt Almac we first became aware of the field of individualized cancer vaccines when we were asked, “Do you think it would be possible to make 20mg of 20 peptides under GMP in less than 4 weeks?” At that time, we knew we were good at making non-GMP peptides quickly through our custom synthesis business, so we wondered if we could combine the two aspects of high-speed manufacture and GMP compliance.

The aim of the neoantigen-based strategy is to get round the issues faced by traditional cancer vaccines (which are too much like ‘self’ for the immune system to see them as foreign) by individualizing the treatment (Figure 1). In brief, a tumour biopsy undergoes next generation sequencing (NGS) to identify the mutations present. A variety of techniques are then used to determine which mutations might result in an antigen that could elicit an immune response. Those ‘neoantigens’ are used as the basis of the vaccine design. The peptides replicate the neoantigens; they are manufactured to GMP, formulated, and the patient inoculated, often in combination with other treatment forms, such as a checkpoint inhibitor.

and described our proposed procedures. In parallel, we supported clients through their submissions to various authorities around the globe. This required a great deal of client intimacy as each had a slightly different set of regulatory requirements. The outcome is a GMP-certified facility capable of producing 20 GMP peptides in less than 4 weeks. This new facility, based in Edinburgh, came online with a single GMP line in September 2018. Very quickly we introduced a second GMP manufacturing line. With two lines in operation we are able to produce peptides at a rate of more than 2 patients per week (more than 40 GMP peptides per week). The duration of manufacture for each patient is typically 3-4 weeks, and manufacture for multiple patients occurs concurrently within our facility which is modular and segregated to strictly prevent cross-patient contamination.

Future outlookIn June 2019, we invested in a 4-fold expansion of our facility, which includes state of the art manufacturing and analytical equipment, and dedicated manufacturing lines to ensure patient segregation. The new facility is designed to produce at a rate of one patient per day (i.e. 20 GMP peptides per day), with each patient manufacturing duration being 7 days (from receipt of order to peptide shipment). This is equivalent to a manufacturing speed which is 1000x faster than that of conventional peptides. Achieving such a rate is made possible through a combination of process intensification, technological development, highly refined facility design and appropriate staffing levels with highly trained and exceptionally dedicated staff.

As more clinical trials come to the fore, the regulatory landscape is likely to evolve. There are currently very few guidelines, but this is likely to change as experience grows. The fact that dosage is so low and products are individualized clearly means that the population risk profile is very different to that of conventional therapeutics, which may present an exciting opportunity to create more unique solutions in future.

Pharmaceuticals

Changing the shape of GMP peptide manufacture Alastair Hay, PhD, Account Manager – Peptides at Almac, explains how the company is advancing human health through innovation and investment in the field of individualized cancer vaccines.

Author: Alastair Hay is Account Manager – Peptides at Almac Sciences, Technophone, Milton Bridge, Tranent EH26 0BE, UK T: +44 (0) 28 3839 5717; www.almacgroup.com NeoPeptide is a registered trademark of Almac Group.

Figure 1: Individualized cancer vaccine generation describing the ‘needle to needle’ process.

Figure 2: Key features of NeoPeptide manufacture

Clearly, for the patient’s benefit, the entire process must be carried out as quickly as possible. Whilst peptide manufacturing is only one link in the chain, it is the most complex manufacturing operation and one that is perceived as a major hurdle to overcome.

Manufacturing set-upSo how do you go about manufacturing 20 GMP peptides in less than 4 weeks? We spent a long time mapping the manufacturing process and flow, understanding where the bottlenecks were, and identifying what equipment, procedures and head count we’d need (Figure 2).

Key to our success was getting to grips with the GMP and regulatory requirements. There is no precedent for the neoantigen field in a regulatory setting, and so we have had to set expectations, gaining feedback from the authorities at every step. Almac does not subscribe to a “GMP-light” philosophy – the manufacturing approach for us had to be a fully compliant GMP approach.

Early on in designing our set up we consulted with the MHRA (UK authorities); we walked them through our process and facility set-up



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The main goal of preformulation studies is to understand the physicochemical properties of the drug substance and how they affect performance. These studies are the foundation for developing a robust dosage form and can increase cost efficiency by reducing challenges during formulation development.1 The results enable accurate predictions of how drug substances will formulate – with or without excipients present.

Bulk characterization of drug molecules involves defining solid-state properties that are likely to change during process development. Assessing crystallinity and polymorphism is critical for solid dosage forms in order to understand the exposure of the product following administration. It is also vital that the post-formulation physical form of the active is defined because of the possible variation in absorption profile. A polymorphism screen recrystallizes the drug compound under various conditions to determine the most thermodynamically stable form. The polymorphs are then characterized and analysed to understand whether they have different properties, such as solubility, stability and melting point.

Technological advancements have enabled scientists to access the molecular level for enhanced preformulation studies. Solid-state nuclear magnetic resonance (NMR) is highly sensitive to slight changes in molecular arrangement, making it particularly useful for identifying variation in crystalline forms.2 The technique can also be used in conjunction with more conventional approaches, such as X-ray powder diffraction. The latest state-of-the-art technologies can provide high-quality data that enable predictions of the best formulation for swift progress to clinical trials.

Thermal analysis is also an important part of preformulation studies. Differential scanning colorimetry measures how a material’s heat capacity changes with temperature and provides information on the most thermodynamically stable form. For amorphous material, it is a good way of assessing information about the glass transition temperature – a physical property that can influence chemical stability, physical stability and viscoelastic properties.3 By combining differential scanning colorimetry and dynamic vapour absorption, scientists can introduce water to the substance and lower the glass transition temperature. This permits a greater understanding of how the drug substance may crystallize over a period of time, or how stability may be compromised throughout the formulation process.

The hygroscopic character of a pharmaceutical material – its ability to absorb or adsorb moisture – is also analysed using dynamic vapour absorption. This is critical from both a formulation and analytical perspective as any changes to the mass of the drug substance from either acquiring or losing water can have an impact on quantitative analytical data. Moreover, hygroscopicity studies enable the prediction of how a drug substance will behave when formulated at different locations around the world, particularly in territories with a very high relative humidity. Without dynamic vapour absorption data, problems during the formulation or manufacture of a drug product could be easily missed.

Determining the level of solubility is another important procedure during preformulation as soluble drugs tend to be better absorbed when administered by the oral route. It is also imperative that scientists investigate the consequences of adding water as part of the formulation programme. This involves asking whether it will partially solubilize the drug substance and, if so, what are the downstream consequences? Analysing the aqueous solubility of a substance can provide results that influence the type of formulation and how it will be administered in clinical studies.

Preformulation investigators apply a wide range of chromatography capabilities to supply accurate solubility data. They can also carry out solubility tests using non-aqueous solvents for instances where they offer better solubility of a drug substance. Solubility studies are not just about determining the instantaneous solubility. It is also critical to determine the potential for crystallization or solvate formation to affect bioavailability following administration.

Preformulation studies also need to circumvent any chemical degradation and physical changes that can occur either during the optimization of the process or following the manufacture of a product. Through the application of appropriate, predictive techniques, stability studies can start to assess physical and chemical stability either alone or in the presence of different excipients under various conditions. This involves subjecting the drug substance to elevated temperatures and relative humidity over a short period of time and then looking at the degradation profile of that drug substance following exposure to stress.

Effective preformulation requires a wide range of cutting-edge instrumentation that can be used to characterize the physical form of drug substances and the actives in drug products. However, many of the techniques do not necessarily run in a protocol fashion and there are a lot of parameters that can be adjusted to probe different aspects of a drug substance or product. It is therefore essential that scientists have the background knowledge and experience to understand any red flags. By utilizing a wide range of methodologies and combining them with the expertise of skilled scientists, preformulation can significantly reduce the time, cost and risk involved in developing a new pharmaceutical product.

References:1. Hasan M et al. Int J Pharm Ther 2017;8:16-32.2. Tishmack PA et al. J Pharm Sci 2003;92:441-74.3. Hancock BC, Zografi G. Pharm Res 1994;4:471-7.

Pharmaceuticals

The impact of preformulation on successful drug developmentStephen Byard, Head of Molecule Development and Scientific Direction at Arcinova, explains how extensive preformulation studies can help reduce risk during pharmaceutical development by supplying evidence of the optimal physical form of a drug molecule.

Author: Stephen Byard is Head of Molecule Development and Scientific Direction at Arcinova, Taylor Drive, Alnwick, Northumberland, NE66 2DH, UK T: +44 (0) 1665 608 300 https://arcinova.com/



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Failure to ensure data integrity is a breach of cGMP. In 2016, 80% of FDA Drug Product and API warning letters included a reference to the lack of data integrity, mainly due to incomplete data. Several regulatory agencies have issued data integrity guidance documents in recent years, all of which follow the definition embodied by the 1990s FDA acronym “ALCOA”:• Attributable: Data must be attributable to the person generating the

data. Who performed an action and when? This can be recorded by initialing and dating a paper record, or by audit trail in electronic records.

• Legible: All data recorded must be legible and permanent, even if corrected or updated

• Contemporaneous: Recorded at the time of task or measurement. Date and time stamps should match order of execution and data should never be back dated.

• Original: Original data, recorded for the first time in database, approved form, or a dedicated notebook. Recording results on paper for transcription later can introduce errors. If hand written data or thermal printouts need to be stored electronically, verified “true copies” may be needed.

• Accurate: Free from errors, reliable, truthful and reflective of the observation. No editing without documentation/annotation of amendments.

Implicit in these requirements for ALCOA are that records should be complete, consistent, enduring and available.

Excipients vs API and Drug ProductExcipients are much more diverse than APIs. They have compositional and molecular weight polydispersity, and excipients are often extracted rather than synthesized, from operations such as harvesting and mining. They are typically manufactured by continuous processes, and in much greater volumes than would be encountered in the pharmaceutical industry. Generally, most excipients were not designed for pharmaceutical

use, although many of them have long histories of patient safety via various routes of drug administration or from legacy applications as food additives.

The various data integrity guidance documents differ slightly in approach and specific details, but are intimately bound to the wider regulatory framework of GMP and good documentation practices, which are based on APIs and drug products. Pharmaceutical usage may only be a small part of a specific excipient market, so most excipients are not manufactured under API or drug product cGMPs. Some suppliers may sell to the pharmaceutical market and leave it to the users to establish pharmacopoeial compliance, which means limited compliance with GMP. The further one gets from pharmaceutical cGMP, the less likely it is that detailed data integrity expectations will be met. ALCOA principles are good business practice in any commercial sector, but judgement will be required in the application of specific pharma data integrity requirements to excipients.

With excipient GMP on a sliding scale, users should anticipate varying degrees of applicability of specific pharma data integrity requirements. Therefore, users need to define which specific data integrity requirements are expected from their excipient manufacturers.

Based on the known marketed applications of their materials, excipient manufacturers should define which records are necessary to support their GMPs and the measures taken to ensure data integrity. Excipient manufacturers lack adequate control of the integrity of their data when they do not literally follow the regulatory guidelines. A common expectation is for manufacturers to provide validation reports for their excipients, analogous to those generated by pharmaceutical companies during API and Drug Product development. FDA requirements are very specific in this respect.

Big Data in QbDTraditionally, pharmaceutical companies performed full compliance testing on each received batch of excipient which meant that less emphasis was placed on supplier Certificate of Analysis (CoA) data

Pharmaceuticals

The data integrity conundrum between pharma and excipientsCPhI Annual Report highlights data integrity key to demonstrating compliance with Pharmaceutical GxPs, such as manufacturing, documentation and laboratory practices.


www.chemicalsknowledgehub.com Pharmaceuticals

integrity. Where users rely on data from qualified suppliers without confirmatory testing (21 CFR 211.84), supplier CoA data integrity is critical. Pharmaceutically aligned suppliers utilize controlled platforms such as LIMS and SAP like those used in the pharmaceutical industry.

From a Quality by Design (QbD) perspective, reliance on purchased CoAs fails the ALCOA criterion of completeness. The number of batches purchased may not be sufficient to statistically represent supplier performance. Access to all CoA data over a period of time gives a more representative picture of supplier process variability for that timeframe. In turn, the CoA data is only complete if there are no out-of-specification (OOS) excipient batches. Full batch data including OOS is necessary for assessment of supplier process capability. It should be noted that for some excipients produced to serve multiple industries there may be “second quality” markets for material outside the pharma specification. Recycling of material would also need to be taken into account in determining process capability.

Many excipients are produced by high-volume continuous production. Of necessity, CoA values will be either average or composite results. QbD drives utilization of more data from excipient manufacturers by pharmaceutical companies, beyond the traditional CoA. It is unlikely that pre-existing systems dating back years, if not decades, were designed with the data integrity requirements of the end-pharmaceutical user in mind. If the data are used for information only and does not control finished product safety or quality data integrity is less of an issue. At the other extreme, real time release (RTR) of continuously produced pharmaceuticals utilizing supplier data would require maximum data integrity.

A second driver to greater utilization of supplier data is the need to demonstrate user oversight of supplier quality. Users are strictly liable for the quality and GMP of their suppliers, including data integrity.

Sharing of data by excipient manufacturer with users may require confidentiality agreements to maintain the manufacturers’ proprietary know-how. There may also be restrictions on use of the data in patent applications and regulatory submissions.

Why is data integrity different for excipients? Industrial control systems are often more focused on safety. Changes to address pharma requirements may have unintended consequences. It is not easy to harden/improve compliance without revalidating safety critical systems. Excipient manufacturers typically use networked control systems to afford remote monitoring and control, in contrast to the small-scale batch operations, typical of pharma.

Many legacy control systems used by excipient manufacturers make data attribution difficult because their control systems are open. If a specific operator is not identified for every action it may be possible to ameliorate by shift rosters, physical access security, training, or a control/data entry log. The degree of GMP at various stages of production may influence the extent of data integrity.

Many industries, including those manufacturing excipients, use redundancy, with multiple sensors and in process tests to reduce dependence on a single data stream. In contrast, pharmaceutical operations are often dependent on a single sensor, which places more emphasis on validation and calibration. Multiple sensors allow voting and reduce dependence on calibration. Data integrity is at a system level higher than that of the individual sensor.

High frequency testing, using “quick and dirty” (nonspecific) methods or sensors, outweighs a limited number of test results from more precise but onerous methods. A better population estimate is obtained, and sampling error is reduced by higher frequency testing, which compensates for lower data integrity at the level of individual

measurement. High frequency automated data capture reduces potential for operator error in sampling or testing. The consistency of surrogate signals can be used for online monitoring with more specific methods to investigate changes.

Increasing utilization by users of supplier data may also pose data retention challenges for the supplier. What data should be retained, for how long, and should it include metadata to enable interrogation of dynamic records? Audit trails and security access controls would be needed for such data. The data retention period could be linked to retention samples, but the excipient manufacturer needs to define this.

User considerations for reliance on third party data sets.If data integrity is uncertain (paper or electronic) the questions to assess the risk are:• Will patients/consumers be injured?• Will product quality be jeopardized?• Will compliance with any cGXP be uncertain?• Will there be increased risk of product liability?• Will there be costs of the poor data quality?• Where on the continuum (information-only to control signal) will the

data be employed?

This analysis will allow development by the user of a prioritized data integrity plan.

Data integrity must be balanced against utility when using a variety of large externally sourced datasets for novel analyses. It is difficult to retrospectively implement controls for validating the data at point of creation or capture, and correcting errors may cause inconsistencies. Rather than trying to control the data creation to preempt errors, the focus changes to identifying inconsistencies and standardizing the data.

The user may not be able to impose specific data integrity requirements on the maker. If pharmaceutical consumption is minor and the requirements too onerous, without commensurate return on investment, there is a risk of the maker withdrawing from the pharma market if no longer economically viable to serve. In the large plants producing excipients there is a bias towards simplification and commodity volumes versus complexity and specials. Pharmaceutical requirements that can be met with incremental investment, and which does not increase operating costs to serve majority markets, are more likely to be accepted.

Quality culture is perhaps more important than integrity of specific data. Pharmaceutically aligned excipient manufacturers should have the personnel, expertise, training and a culture for employees to raise issues and follow good data governance. It will then be much easier to deal with any mismatch in data integrity expectations between user and maker.

Ahead of this year’s CPhI Worldwide, we are summarizing the findings of a previously unpublished in-depth piece from last year’s CPhI Annual Report. The full findings in this year’s Annual Report will be released at CPhI Worldwide in November and all previous annual reports are available online at https://www.cphi.com/europe/visit/news-and-updates/industry-market-reports.

Authors: Brian Carlin, Director QbD/Regulatory DFE Pharma; Dale Carter, Head of Quality Silica Americas Evonik; Irwin Silverstein, President, IBS Consulting in Quality LLC; Ann Gulau, Quality Assurance, Dow Chemical Company; Brittney Wells, Regulatory Lead, CQA, CQE, PCQI, Lonza; Katherine Ulman, Primary at KLU Consulting



Olfaction – our sense of smell – is arguably the oldest sensory modality, going back as far as simple chemo-reception in single cell organisms. In terms of our understanding of it we are, however, much behind vision and hearing. The most prominent issue is the problem of the vast size of chemical space and the lack of organizing principles in it. While light can be described precisely by wavelength and amplitude, odours consist of volatile chemicals, mostly organic compounds, that can be described by thousands of chemical descriptors. Even though some progress has been made, it is yet unknown which of these descriptors are useful to reflect the nature of odours in order to describe their perceptual qualities.

The second problem, which I will focus on in this article, is that natural odours are typically mixtures of a large number of different chemical compounds and that these mixtures disperse in our environment in very complex spatial-temporal structures, so called odour plumes. A typical natural odour has dozens of components that are above detection threshold for an animal nose. Coffee smell, for instance, has more than 1,000 individual odorants, of which some 20–30 are essential to achieve a realistic aroma.1 When released into the air, this mixture disperses wildly in small filaments,2 much like the smoke above a candle that has been blown out (Figure 1). For animals, this means that smells don’t arrive in an orderly fashion but come occasionally as short whiffs, interspersed with pockets of clean air.

If more than one source of odour is present, which typically is the case, filaments from different sources arrive together or separately, in – for lack of other words – a big mess. This may seem daunting but our collaborators at the University of Konstanz recently discovered that the olfactory perception of insects is so fast (unlike anything previously thought) that the animals can take advantage of the strong temporal structure of odour plumes rather than being flustered by it.

In brief, Szyszka and colleagues3 investigated whether bees could recognise a previously rewarding odour within a mixture with a novel odour. Cunningly, they varied how the odours were mixed, presenting them either at the same time, or delaying one of the odours for a very short time. They found that bees were able to distinguish “synchronous” from “asynchronous” mixtures and recognised the rewarding odour better in the asynchronous situation. Surprisingly, when they started to probe for the minimum time difference that could be resolved, bees were able to distinguish tiny 6 millisecond delays from the synchronous condition. Using computational models of the bee brain, we were subsequently able to show that this observation is consistent with a well-known brain motif of mutual inhibition and so-called winner-take-all dynamics in the antennal lobe, the primal brain centre for olfactory information processing in the bee brain.4

This research has opened up a new view on the complex nature of odour plumes and how they are perceived by animals. Rather

Odour objects – progress in understanding how we smellThomas Nowotny, from the University of Sussex, outlines recent research on how the brain interprets natural odours, which are complex mixtures of a large number of different compounds

Fragrances

Figure 1: Illustration of complex odour plumes. Top panel: spatial distribution of two odours in a turbulent plume (green, purple). Bottom panel: profile of odour concentration that would be encountered by a bee were it to fly along the trajectory indicated by the black line in the upper panel. Note the strong and rapid changes of odour concentration.Figure credit: Paul Szyszka, University of Otago, New Zealand.

Author: Thomas Nowotny, Sussex Neuroscience, School of Engineering and Informatics, University of Sussex, Falmer, Brighton BN1 9QJ, UK E: [email protected]

than adding complexity, the nature of odour transport in complex odour plumes can be an aid for animals to distinguish odours from separate sources, and so segment the odour percept into separate “odour objects”. We hypothesize that similar processes happen in the human brain and underlie our ability to interpret the chemicals that enter our nose when we go to a coffee shop to be the smell of coffee and bacon, rather than “coffeebacon”, “baconcoffee” or an entirely meaningless mixture of dozens of chemical compounds.

Our research into odour object recognition has continued in the “odour object” project (www.odor-objects.org), in which we also discovered that mixtures of odours are more stable percepts than single compounds.5 Our next task will be to investigate the pre-processing of odour percepts in sensory organs, in particular by non-synaptic interactions within the sensilla (sensory hairs) on insect antennae.

References:1. Sunarharum WB et al. Food Res Int 2014;62:315–25. 2. Murlis J et al. Physiol Entomol 2000;25:211–22. 3. Szyszka P et al. PLoS ONE 2012;7:e36096. 4. Nowotny T et al. Brain Res 2013;1536:119–34.5. Chan HK et al. PLoS Comput Biol 2018;14:e1006536.



In-car smell is a big topic in the automotive industry. Scent diffusers are becoming increasingly popular in modern vehicles, but their current function does not go beyond the enjoyment of the driver and/or passengers. Academic research is investigating scents in the context of Advanced Driving Assistance Systems (ADAS) and autonomous vehicles (AV). Recent findings have demonstrated that scents can be used to convey driving-relevant information, but can they also make the process of driving safer?

Driving is a highly visual task. Nevertheless, it is a process that involves other senses too. When we drive, we touch the steering wheel, we listen to what is happening around us, and, even if we are not paying attention to that, we smell what is happening – a scent of gasoline, burning rubber, plastic heated by the sunlight, for example. In fact, smell is able to provide a much more vivid experience than any other human sense.

Moreover, the sense of smell could deliver benefits in terms of safety. If we see a "service due" light on the dashboard, we might ignore it, but if we smell something burning, we would probably stop immediately. Self-driving cars could potentially reduce visual demand, allowing the driver to focus on a secondary task. Nevertheless, even in such scenarios, the driver might need to monitor the automation performance. Could this requirement be minimized with the help of scents and, most importantly, would this contribute to the safety of driving?

Such a benefit of using olfactory stimulation in the car as a strong link to memories and emotions has been the motivating factor for the recent advancements in the automotive industry, where multiple manufacturers, including Mercedes-Benz and BMW, have created their own in-car scents to enhance hedonic driving experiences. Moreover, research has shown that scents have a positive impact on the alertness and mood of the driver,1 drivers’ braking performance,2 and on keeping drowsy drivers awake.3 However, the interfaces used in these examples

are delivering only ambient scents, without making use of the ability of scents to provide hints to the driver. This is happening despite the potential of scents to convey information, which is evidenced by findings in psychology and neuroscience.

Scents have been demonstrated to mediate cross-modal correspondences.4 They are able to support object localization and identification tasks, as well as help capture people’s attention. If olfactory notifications are used to notify the driver about an upcoming danger (e.g. a pedestrian suddenly appearing in front of the car), then a carefully chosen scent could make the driving safer. For example, one of our studies has shown that the scents of rose and peppermint result in a significantly lower number of crashes than when dangerous events are signalled using the scent of civet (Figure 1). This was true for drivers in an induced angry state.

Anger is a dangerous emotion to experience when driving a car, as it may lead to road traffic accidents. The study mentioned above has also shown that the scents of rose and peppermint improve the mood of drivers, suggesting that they could become less angry if they are exposed to scents like rose and peppermint throughout the driving. Consequently, this might help maintain safer driving behaviour.

In a context of autonomous driving, olfactory notifications could help the driver monitor the self-driving car better, employing an olfaction-enhanced reliability display. A recent study5 demonstrated that there is an improvement in the secondary task performance (i.e. interacting with a mobile device) when scent-based reliability displays are in use. The scent of lemon was used to notify the driver about a switch from high to low reliability, and lavender signalled a switch from low to high reliability. Moreover, such displays resulted in a better trust in the AV, while contributing to its ease of use and perceived usefulness.

In conclusion, research provides evidence for the ability of scents to make ADAS and AVs safer to use. Scents could help us become calmer on the road and maintain safer driving behaviour. In a context of self-driving cars, scents could support the task of monitoring the reliability level of the automation (i.e. prepare the driver for a potential emergency), while also making us more likely to keep using such systems. This suggests that we should continue exploring olfactory interaction and expanding the range of its application scenarios in the car.

References1. Raudenbush B et al. N Am J Psychol 2009;11:245–56.2. Martin G, Cooper J. In The British Psychological Society Annual Conference 2007.3. Oshima C et al. In Workshop on DSP for in-Vehicle and Mobile Systems 2007.4. Castiello U et al. Chem Senses 2006;31:665–71. 5. Wintersberger P et al. In IUI ’19 (2019), ACM, New York, NY, USA.

Scents and self-driving cars Dmitrijs Dmitrenko from the Sussex Computer-Human Interaction (SCHI) Lab explains how scents can be used to convey driving-relevant information, and asks the question – can they make driving safer?

Fragrances

Figure 1. The mean number of collisions experienced by drivers, when they areexposed to water (clean air), rose, peppermint, and civet scents. *p < 0.05; ***p < 0.001; Error bars: standard error of the mean.

Author: Dmitrijs Dmitrenko, Sussex Computer-Human Interaction (SCHI) Lab, Creative Technology Research Group, School of Engineering and Informatics, University of Sussex, Brighton, UK E: [email protected]

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Regulations governing the fragrance industry are complex and it is an ever-changing environment. We must consider not only international, industry and product regulations but also ensure that our fragrances comply with our customers’ requirements. The uncertainties of Brexit bring an added set of challenges for our sector, as for so many others.

Fragrance houses try to assist their clients in keeping up to date with these regulatory changes. CPL Aromas does so by holding Regulatory Seminars, enabling our clients to discuss the challenges they face and updating them about any regulatory changes.

The new IFRA 49 Standards are due to be published later this year (2019) and this represents the most fundamental change to the IFRA standards since 2006. This industry body – the International Fragrance Association (IFRA) – is a global organization that plays a major role in self-governance for the sector. IFRA has a Code of Practice which ensures consistency and compliance for the use of fragrance materials, regulating the safety of fragrance materials and compounds and ensuring human and environmental safety.

IFRA 49 will include an update to the list of categories and number of standards. It will also include a change to how the levels are calculated, moving to a quantitative exposure-based risk assessment with cumulative and systemic effects taken into account as well as the current sensitizing effects of certain materials used by perfumers.

The introduction of IFRA 49 means that new documentation will be sent to all clients advising them of the new IFRA limits and timelines for implementation. This could mean a change to the allowed level of fragrance in their products. We also expect the number of IFRA categories to rise to 12 from 11 and the number of sub classes to drop to 16 from the current 22. The implementation timeline once the standards are published is expected to be 13 months for new creations and 2 years for existing fragrances.

Alongside IFRA 49, one of the other issues the sector faces now is the challenge of reclassifications of key fragrance ingredients.

Following the process of REACh and the introduction of additional testing requirements, this has led to several reclassifications of some of our commodity items which in turn can lead to the re-classification of our customers’ products. This is particularly of note for air fragrance products such as candles or reed diffusers where CLP labelling is a requirement.

The natural fragrance market is dynamic and growing and CPL Aromas’ Natural Platform responds to this trend. Consumers are becoming increasingly aware of what they are buying, leading to a growth in ethical brands. Fulfilling a sustainable lifestyle however can be challenging when marketing is often driven and confused by vague claims and a glossary of terms that doesn’t have industry recognition or firm definition.

Driven by the next generation, the beauty community is looking for products that work holistically with people’s health concerns, ensure kindness to the planet and offer supply chain transparency.

The CPL Aromas’ Natural Platform is a drive to create 100% natural fragrances that will define the naturals market in an educational and transparent way.

The fragrance industry always tries to stay several steps ahead of regulatory needs or public demand. A good example of this is the development of technological solutions to support sustainability needs as demonstrated by CPL’s EcoBoost Fragrances. These use just 10% of the normal fragrance dosage with no compromise in strength or quality, leading to a reduction in packaging as well as reduced transport, energy and disposal costs.

The requirement to label your non-cosmetic products according to CLP and the increased reclassification of materials as noted earlier means EcoBoost comes into its own. Its lower dosages are often below the regulatory threshold required for these labels, and so do not require on-pack labelling.

Brexit negotiations bring complexities to the work we do and, from a regulatory perspective, the main concern is REACh. In the event of a ‘no deal’ Brexit, the UK will be immediately responsible for regulating chemicals through its own legislation.

We are working with our suppliers to confirm that any raw materials produced or imported into the UK in relevant quantities with existing EU REACh registrations are ‘grandfathered’ into the UK regime; and we aim to ensure that raw materials produced in the UK continue to be EU REACh compliant.

However, we have met the challenges head on by pre-empting possible difficulties. In preparation for what could be a major change, CPL Aromas bought an existing Spanish fragrance house which is now operating as CPL Aromas Spain. This gives CPL an EU manufacturing base well ahead of the point when the UK leaves the EU.

Fragrance regulationsCharlotte Purcell, Global Technical Director of CPL Aromas, gives her personal perspective on dealing with regulations, meeting current trends and coping with Brexit.

Fragrances

Author: Charlotte Purcell, Global Technical Director of CPL Aromas, Innovation House, 97 London Rd, Bishop's Stortford, CM23 3GW, UK www.cplaromas.com

Charlotte Purcell, Global Technical Director

of CPL Aromas



Within the cosmetics industry, Dr Dayan believes that a greater understanding of the microbiome will assist in interpreting the impacts of lifestyle and environmental factors on our skin condition, some of which cannot be explained solely by the function of our own cells.

“By studying the behaviour of our own cells only in epigenetics, we ignore an extremely significant factor of our wellbeing,” she said. “The bacteria, viruses, fungi and mites that inhabit our body control many functions. Perhaps the main insight is that since these organisms need us to survive and thrive, nature most likely did not create them innately hostile but rather friendly”.

As interest in the skin microbiome has grown, the breadth of tests and methods for research has also expanded.

“Depending on the depth of research and investment, the products can be tested in vitro in various models or in vivo in clinical studies,” Dr Dayan explained. “There are now models available that allow the introduction and co-culturing of bacteria in 3D artificial skin models.”

However, for a claim for efficacy to be made, researchers need to demonstrate a change in clinical manifestation. As already explained, for medical applications, this may be more clear-cut than with cosmetic changes, which could arguably be more subjective. Especially considering the diversity of the ‘normal’ microbiome, the demonstration of cosmetic efficacy is one of the greater challenges currently facing developers of these products.

Looking to the future, Dr Dayan believes that we will continue to look at ever-smaller elements, moving towards a greater understanding not just of the microbiome, but also of quantum biology.

And what does this mean for the manufacturers of speciality chemicals, including the ingredients of cosmetics and personal care products?

“It seems that as we understand more about the skin microbiome and its importance to health and wellbeing, perhaps the effects of any natural or synthetic ingredients on the balance of skin microorganisms may need to become a factor for greater consideration,” says Dr Dayan. “Since the skin microbiome is relatively stable throughout long periods in our life, in the future we may wish to consider aspects related to the effect of long term cumulative exposure of cosmetics and personal care products on the skin microbiome and its potential correlation to overall ‘skin health’.”

Nava Dayan, Owner of Dr Nava Dayan LLC, will give a talk at in-cosmetics North America on ‘Skin microbiome related cosmetic products – Challenges and opportunities’ – on Wednesday 23rd October at 4:45 pm. For more information about the in-cosmetics North America education programme, visit: https://northamerica.in-cosmetics.com/education/

Targeting the skin microbiome Nava Dayan PhD Pharm D, Owner of Dr Nava Dayan LLC – a skin care consulting company for Pharmaceuticals and Cosmetics – discusses the challenges and opportunities for products targeting the skin microbiome.

Cosmetics & Personal Care

Nava Dayan, Owner of Dr Nava Dayan LLC

The impact of microorganisms on our wellbeing is becoming more accepted, although the practical means of influencing the skin microbiome is yet to be perfected. In recent years, numerous active raw materials and finished products claiming to affect the skin microbiome (either directly or indirectly) have been launched. Nava Dayan, Owner of Dr Nava Dayan LLC, spoke to Sarah Harding, PhD, about the latest research and development in this field, and challenges and opportunities for products targeting the skin microbiome.

Starting with the current status of the field, Dr Dayan explained that the skin microbiome is now being researched for both medical and cosmetic purposes.

“Thanks to efforts unravelling this area in recent decades, and the development of more accurate and cheaper methods for research, we are now collecting information on the nature of the skin microbiome in health and disease,” she said. “There are already pharmaceutical companies that develop biologics to treat skin disorders via the manipulation of microbial dysbiosis. Research in cosmetics is more complicated for two reasons: (1) the healthy skin microbiome is typically more diverse, so the data obtained can be more complicated to analyse; and (2) whereas in pharma there is a perceivable disease that is healing, and the clinical manifestation of healing is a key study endpoint, in cosmetics the product is applied to healthy skin, so it is harder to associate the impact of product use to clinical change manifestation unless it is significantly altering appearance.”

Nevertheless, a great deal of research is ongoing in the cosmetic field. Dr Dayan highlighted mapping the healthy microbiome in association with age, ethnicity or gender as a key area of research for cosmetics.

“The future will require a deeper understanding of the connection and interaction between the microbiome and human cells,” she said. “The microbiome and our cells have ‘conversations’ via various paths – a major one is termed ‘innate immunity’. I have studied this path for more than a decade now – anyone interested in the field can refer to a book I published [by Wiley and Sons] in collaboration with ProfessorPhil Wertz in 2012.”



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Clean beauty is wide reaching, covering ethical sourcing, sustainable packaging, thoughtful manufacturing and transparent business models in a cruelty-free environment. It means taking care of the planet as we take care of ourselves. Karen Young, CEO of The Young Group, spoke to Sarah Harding, PhD, about the macro-trend of ‘clean’ living in the beauty industry.

What is driving the macro-trend for clean beauty? There’s been a huge shift in consumer behaviour towards clean beauty across many regions of the world. Consumers are more acutely aware of lifestyle choices and the wider impact that ingredients used in personal care and household products have on the world. What was once a micro consumer trend, focusing on personal health and the environment, has now become a macro-trend, driven by increased cases of asthma, allergies and skin problems, as well as heightened consciousness about climate change.

How is the North American market responding to the trend? From a marketing and consumer perspective, the clean beauty category is exploding with double-digit growth. The challenge lies within the supply chain, which is not fully prepared to keep up with this unprecedented consumer demand. The pressure continues to mount on the supply chain as close to a thousand indie brands launch annually in the US, with the majority prioritizing ‘clean’ within their brand vision.

How can speciality chemicals manufacturers ensure that they are part of this trend? Since nothing about ‘clean’ is clearly defined, it's difficult to address the topic rationally. It can encompass ethical sourcing, the sustainability of ingredients (including whether they are naturally derived, cruelty-free, vegan or green), as well as transparent manufacturing – the list is long and confusing.

Raw material suppliers need to find an authentic path to address this movement if they want to be part of the change and benefit from it. This could be achieved by focusing on a number of their ingredients that fit the bill, or by examining their processes for manufacturing or sourcing.

Perhaps suppliers can create a corporate social responsibility (CSR) plan where they ‘give-back’ to the communities that they source the ingredients from. There are endless opportunities, but the effort needs to be genuine and transparent because consumers are savvy.

Clean beauty is not yet regulated – should it be? At the moment, we can't even come to a consensus on the definition of ‘clean beauty’, so I would imagine regulating it would be very challenging indeed. We haven't yet regulated ‘natural’, which has been on our horizon much longer.

I suspect we will see organizations popping up that will try to define and showcase what ‘clean’ means. For example, the Environmental Working Group (EWG) defined ‘cruelty-free’ by highlighting that in China animal testing is still required on personal care products, whereas most of the western world (with the EU leading) is trying to abolish this practice.

Is clean beauty here to stay? In some iteration, yes. Consumer awareness has definitely risen; many are now convinced (not always from reliable sources) that there are countless toxic ingredients in cosmetic products that need to be substituted.

Certainly, as more and more consumers are adopting wellness into their lifestyles to reap the rewards of meditation, exercise and nutrition, meaning ‘clean’ living will remain a focus.

Karen Young, CEO of The Young Group, will lead a session at in-cosmetics North America on ‘Beauty and clean living - How is the cosmetics industry adapting to this trend?’ – on Thursday 24th October at 12:45 pm. The session will explore the macro trend of ‘clean’ living in the beauty industry as consumers demand more than just ‘natural’ ingredients, as they scrutinize every link in the supply chain. For more information on the in-cosmetics North America 2019 education program, visit https://northamerica.in-cosmetics.com

The macro-trend of clean beauty

Karen Young, CEO of The Young Group, explains that consumers are demanding more than ‘natural’ ingredients – they are going deeper and forcing the industry to re-evaluate every link in the supply chain.

Cosmetics & Personal Care



Great strides are being made in the use of artificial intelligence and machine learning in the fragrance industry which are bringing about a quiet revolution in the way that we work.

At IFRA UK’s Fragrance Forum you will be able to find out more about the emerging developments that are taking place from a range of speakers including Google, Givaudan, University of Sussex and Aromyx.

Tuesday 15th October 2019Timings: 10am – 4.30pm

Tickets are £180 plus VAT, lunch is included

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The current drive to eliminate polymers from packaging – most recently emphasized by the publication of the EU’s draft Directive on single-use plastics – is making packaging a key market for biopolymers.

Data from a recent report by Smithers, a worldwide authority on the packaging, paper and print industry supply chains, show that worldwide consumption of bioplastics in packaging is expected to increase from 1.50 million tonnes to 3.18 million tonnes over the next 5 years.1 The total value of this market will rise at 15.0% year-on-year from 2019 to 2024, from $4.40 billion to $8.83 billion. Three key factors are shaping the outlook for these materials: beverage bottles, bio-polyethylene (PE) plastics and polylactide (PLA) polymers.

Beverage bottlesThe fastest growing application for bioplastics will be in beverage bottles, as this market grows from $1.20 million to $3.17 billion across 2019 to 2024.

Main demand will come from bottled waters and carbonated soft drinks. In the latter application global brand owners Coca Cola, Nestlé and PepsiCo have already contributed to development work to designing bioplastic versions of PET bottles. Each of these companies has also signed ambitious goals to minimize the impact their packaging will have on the environment, with targets set for 2025.

The main demand in this segment will be for bio-PET – constructing the polyethylene terephthalate polymer from bio-sourced raw materials. This has the advantage that it can be a drop-in replacement for oil-derived PET, and used in existing blow-moulding lines.

Currently, bio-PET is blended with conventional PET. Competition is vigorous to minimize the percentages of conventionally derived PET, while matching key performance characteristics such as barrier performance and clarity. Perfecting and industrializing processes to make 100% bio-PET is a high R&D priority among companies, but large-scale production of fully bio-PET pack formats is unlikely before 2024.

Bio-PE/PPBioplastics – polyethylene (PE) and polypropylene (PP) – synthesized from plant-source ethylene monomers in conventional PE production facilities will be the second most important material type for packaging industry over the next 5 years.

The properties of bio-PE, and of the underlying ethylene monomer, are indistinguishable from the properties and performance of comparable fossil-sourced materials. Fermentation-based ethanol is readily converted in industrial chemical processes to bio-ethylene monomer, and thence to bio-PE plastics.

Bio-PE is expected to grow rapidly from about 470,000 tonnes in 2019 to almost 952,000 in 2024. Growth, however, will be constrained by capital investment and plant construction schedules.

PLAPLA polymers are derived via fermentation from plant-based starches such as corn, sugar beet, cassava and wheat. These have been subject to a large volume of research funding in recent years which is now poised to come to fruition.

Currently, PLA grades can cost 20–50% more than conventional polymers used in similar applications. This is limiting their commercial viability. Future priorities for companies active in this area include optimizing genetics and microbiology to improve the efficiency and selectivity of fermentation microorganisms, and developing new PLA formulations to address needs of specific packaging applications.

Reference1. Smithers. The Future of Bioplastics for Packaging to 2024, July 2019

(www.smithers.com)

Material opportunities for bioplastics in packaging Packaging applications present a major future growth market for bioplastics as the global polymer industry looks to commercialize production across the next 5 years, says Smithers’ John Nelson.

Plastics & Polymers

Author: John Nelson, Commissioning Editor at Smithers, Cleeve Road, Leatherhead, Surrey, KT22 7RU, UK. www.smithers.com

Image by congerdesign from Pixabay



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Founded in 2008, Anellotech was set up to develop a technology platform to create more sustainable products. Demand for greener everyday household goods, such as food and drinks packaging – as well as more sustainable ways to power our transport, like biofuels – continues to rise.

Anellotech has created a pathway to 100% bio-based drop-in aromatic chemicals and fuels from non-food biomass. By using proprietary Bio-TCat technology, chemical producers and brand owners can meet environmental sustainability goals thanks to the process’ lower carbon footprint and cost-efficiency.

To date, over $85 million of cash and in-kind funding has been raised by Anellotech, coming from industry-leading strategic partners. The company’s R&D team has accelerated cost-competitive technology development and commercialization through long-term partnerships, with industry leaders Suntory, Toyota Tsusho, IFP Energies nouvelles (IFPEN), Axens and Johnson Matthey.

Creating an efficient, cost-competitive and scalable bio-based process is a significant challenge. However, Bio-TCat technology is making that goal a reality. Alongside development and licensing partners IFPEN and Axens, Anellotech is now planning for design and engineering of its first commercial plant. Engineering work has begun and the next phase of construction is planned for the second half of 2020. Anellotech also is moving forward to using plastic waste as a feedstock for chemical recycling through its new Plas-TCat process.

Innovative technology creating bio-based aromaticsBio-TCat technology produces a mixture of bio-based benzene, toluene, xylene (BTX) – as well as larger aromatics – all of which are chemically identical to petroleum-derived counterparts. The family of liquid products made in the Bio-TCat process are called AnelloMate and include:1. ‘AnelloMate BTX’, a naphtha containing over 90% bio-BTX2. ‘AnelloMate Distillate’, a middle and heavy distillate range

hydrocarbon mixture.

AnelloMate products offer a unique opportunity as cellulosic-sourced biofuels with the same properties as conventional fuels, including fungibility in fuel distribution systems.

Bio-TCat’s product slate provides greater flexibility and the opportunity to serve dual product markets. If renewable chemicals-to-polymers markets are the targets, AnelloMate BTX can be separated to make high purity bio-based aromatic chemicals. If the goal is to make fuels, it makes a high-octane gasoline/petrol blendstock. In both cases, the Anellotech Distillate stream is used as bio-marine fuel, or it can be upgraded to make diesel or jet fuel blendstocks.

Bio-TCat thermally breaks down biomass which is then catalytically converted into BTX in the same reactor. This single-step process uses a

proprietary zeolite catalyst, which Anellotech has jointly developed with Johnson Matthey, to produce bio-BTX with commercially-attractive yields.

Going directly from biomass to BTX in one step avoids highly-oxygenated bio-oil intermediate products, often seen in multi-step pyrolysis processes avoiding the need to use significant amounts of costly hydrogen.

Bio-TCat has been demonstrated at Anellotech’s TCat-8 pilot plant in Silsbee, Texas with extensive time onstream, operating for 7,500 hours. TCat-8 has been converting wood into hydrocarbons, performing mass balances, confirming product yields and catalyst performance, collecting data needed for commercial scale design, improving operational performance and running the unit making AnelloMate products for product development work.

TCat-8’s operation has confirmed product yields and catalyst performance. Process control and process reliability insights have also been obtained – critical factors for commercial operation and design.

Many applications and usesBTX aromatics produced using the Bio-TCat Process can be used in a range of chemical applications to make commodity plastics such as polyester (polyethylene terephthalate or ‘PET’), polystyrenes, polycarbonates, nylons, ABS (acrylonitrile-butadiene-styrene) and polyurethanes, which are used to manufacture consumer goods such as beverage bottles, food packaging, clothing, footwear, carpeting, automotive and electronic components. BTX component benzene is also used to produce LAB (linear alkyl benzene), a strong surfactant used in laundry detergents.

Anellotech also has developed MinFree technology, an innovative, biomass pre-treatment process. With patents pending, MinFree has been demonstrated to significantly reduce the mineral (ash) content of loblolly pine at a 20 metric ton/day scale. Month-long trials converting MinFree-treated, low-mineral pine into bio-BTX at Anellotech’s pilot plant showed extended, economic catalyst life.

MinFree is expected to provide similar results with other woody biomass like eucalyptus and hard woods as well as agricultural residues like cotton straw, sugarcane bagasse and corn stover. We believe these advances could provide expanded feedstock flexibility and performance to many different applications.

Alternative waste feedstocksSo far, Bio-TCat aromatics have been produced using loblolly pine feedstock from the southern United States. Loblolly pine is abundant, low-cost and there is an existing, highly-efficient supply chain for growing, harvesting and transporting millions of tons for industrial applications.

Advancing bio-based chemicals and fuels David Sudolsky, President & CEO of Anellotech, explains that by targeting the production of renewable chemicals and fuels from non-food biomass, Anellotech’s sustainable technology Bio-TCat has completed its R&D program and the company is currently planning construction of its first licensed commercial plant. Anellotech also is advancing its new breakthrough plastics chemical recycling process. Plas-TCat uses plastic waste as a feedstock through the same technology platform.

Plastics & Polymers


www.chemicalsknowledgehub.com Plastics & Polymers

However, the MinFree and Bio-TCat processes can be adapted to use other non-food biomass inputs. Anellotech is now selecting and testing additional feedstocks for further commercialization.

With plastic waste representing a significant societal challenge, Anellotech plans to leverage its technology, laboratory facility, pilot scale infrastructure and partnerships to economically convert plastic waste into commodity chemicals. Using the Plas-TCat process, these resulting product aromatics and olefins can be used to make virgin polymers to use in food and beverage packaging, textiles and plastic components for consumer products, the automotive industry and other markets. Plas-TCat also will allow conversion of mixed plastics streams, including composite films.

By using Plas-TCat to recycle plastic waste, companies could produce aromatics and olefins directly and these products will be more valuable compared to producing straight pyrolysis oils. An expectation of valuable products with a high yield could potentially pay for plastic waste feedstock in countries without subsidized trash collection infrastructure. Anellotech’s pilot plant is already in place – only minor modifications would be needed to handle plastic feedstock instead of wood.

Textiles are another alternative feedstock being explored through the new process Tex-TCat, which also leverages the Anellotech technology platform. Under consideration for conversion are cotton fabrics, synthetic fabrics (polyester, nylon, Lycra/Spandex, etc) as well as blends to turn into valuable aromatics and other chemicals to use as a ‘drop-in’ replacement for the petroleum-derived aromatics used to make the same virgin synthetic fabrics, or biofuels.

Creating 100% bio-based PET bottleAnother focus has been on commercializing bio-paraxylene – Anellotech has collaborated with Suntory, one of the world’s leading consumer

beverage companies, in this effort. Bio-paraxylene is the key missing component needed to make 100% bio-based PET bottles. Suntory currently uses 30% bio-based PET for its Tennensui brand of mineral water but the aim is to make a 100% bio-based PET for Tennensui and potentially other brands in the future.

A BTX sample produced at TCat-8 has already been converted into high-purity bio-paraxylene, and larger volumes are now being prepared to make a 100% bio-PET resin for prototype bottle manufacture and product testing. These high-purity bio-paraxylene test samples have met the ASTM international specifications for downstream derivatives including PET conversion. This will be the industry’s first production of bio-PET from continuous, cost-effective processing of non-food biomass.

Sustainable technology confirmed by LCA Made from renewable feedstocks, Bio-TCat products enable significant GHG reductions when compared to identical chemicals currently made from crude oil. This was confirmed by Jacobs (Jacobs Engineering Group Inc.), who conducted an in-depth review of Anellotech’s greenhouse gas emissions (GHG) lifecycle analysis (LCA) using its industry-respected refinery and petrochemical process models.

The LCA compared Bio-TCat aromatics produced using sustainably-sourced loblolly pine feedstock from the southern United States, to petro-aromatics produced in the US Gulf Coast from three crude oils, which represented a range of carbon intensities. Jacobs employed their proprietary models for oil production, transportation and refining to estimate the carbon intensity of producing high-purity paraxylene and benzene products.

The results found that CO2 emissions for producing paraxylene and benzene from pulpwood using Anellotech’s process are estimated to be 70–80% lower than emissions for identical petro-based chemicals made from crude oils. If Bio-TCat is configured to make renewable gasoline and distillate fuel blendstocks, the reduction potential exceeds 90% as fuels are burned to make energy.

Commercialization, partnerships and future plansAnellotech is seeking to extend its strategic collaborations and license Bio-TCat to customers who want to capitalize on the improved sustainability and competitiveness of its technology to build and operate commercial plants. Biomass suppliers, chemicals manufacturers, refiners, brand owners and others across the supply chain are welcome to enquire about joining the Anellotech alliance network.

Research programs for chemical recycling of waste plastic and waste clothing are underway. Strategic partner engagement is welcome for both development funding and complimentary expertise in the waste supply chain, and future commercial plant locations.

The company will continue to work with its partners to ensure performance, delivery and quality – essential as Anellotech moves ever-closer to delivering its first commercial Bio-TCat plant.

Author: David Sudolsky, President & CEO of Anellotech Inc, 401 North Middletown Road, Pearl River, NY 10965, USA T: +1 845 735 7700 E: [email protected] www.anellotech.com Bio-TCat, Plas-TCat, AnelloMate, MinFree and Tex-TCat are registered trademarks of Anellotech.

Anellotech’s T-Cat8 pilot plant in Silsbee, Texas.



From climate change and hunger to ocean health and deforestation the global issues we face in the 21st century require global solutions. And, as research has found over and again, innovation and collaboration are both key. There is, as the World Economic Forum describes, a current “revolution in collaboration for action” and it’s sparking NGO, community, government and business partnerships in many forms.

This is no less the case for the global plastics waste challenge, and speciality chemical company Clariant has announced a new initiative – the ‘Symphony of Collaboration’ – to foster partnerships and create a more sustainable plastics industry.

We know that plastic is integral to our modern, globalized lives yet its sustainability is increasingly under the spotlight. In this context, and within the current growing momentum of collaboration, Clariant’s ‘Symphony of Collaboration’ recognises that regulators, industry and society have a responsibility to work more closely to drive design for, and innovation in, the reduction, reuse and recycling of plastics.

At K 2019, Clariant will shine a light on collaborative sustainability projects, and the products behind them, supporting the development of solutions that will be adopted in the market, with a specific focus on recycling. This includes Clariant’s Masterbatches Business Unit imagining a future where design for recycling, reuse, biodegradable polymers and bio-based polymers give customers what they need, the company’s Additives research teams working to increase the use of renewable materials in stabilizers, antioxidants, odor scavengers, compatibilizers, processing aids and lubricants, and the Business Unit Pigments working on colour in plastic packaging in a circular economy world.

Recycling is already recovering large volumes of plastic waste for reintroduction to the marketplace as new packaging but there are still major challenges for increased use of post-consumer resin (PCR). A key priority is to ensure the attractiveness of virgin PET and, at K 2019, Clariant will launch a new masterbatch for PET destined for the food and beverage market. The patented oxygen scavenger is based on a new molecule that goes beyond existing solutions for PET in protecting content shelf life and taste. It’s proving a real success in initial customer trials, offering the potential to address a number of challenges for packaging producers in one solution.

Working together to solve the problems that matterAlso at K 2019, Clariant will unveil the results of some of its flourishing partnerships that have already delivered some breakthrough results.

For example, together with the Finnish oil refining company, Neste, which is passionate about giving fat residues and discarded cooking oils a second life, Clariant has been exploring opportunities to use renewable hydrocarbons, derived from this waste.

With another partner, for Near Infrared (NIR) scanners , the company has developed new colorants for the black coloration of plastics, that can be identified by NIR sorting devices. This new range can be used for various polymers (e.g. Polyolefins, PET, PA) and applications such as packaging and E&E, offering brand owners and masterbatch producers new opportunities.

In a further drive for collaboration, Clariant is taking its EcoTain sustainability label, currently awarded to a portfolio of more than 200 products, to the next level. EcoTain is being expanded to include EcoTain Partnerships that will foster collaboration between at least three partners in the value chain, advancing environmental protection and the circular economy. At K 2019, Clariant will issue an open invitation to companies to come together and collaborate specifically on one particularly challenging aspect of recycling.

Opening dialogues from science to solutionsThe complexity of the global plastics challenge is far too big for any party to tackle alone and the ‘Symphony of Collaboration’ will open dialogues and spur innovation. Clariant’s Richard Haldimann, Head of Innovation Excellence and Business Incubator, said that the company is proud to be fostering these partnerships across the value chain, from producer to recycler.

Haldimann commented, “We’ve learned from experience that the wider problem can’t be solved at an individual company level. It’s a system problem and collaboration is key.”

Inevitably, as we push the boundaries of current thinking, there will be bumps in the road and we will all need to keep our focus. What is clear is that advancing plastics through dedicated cooperation will be critical if we want to scale up solutions that have real impact.

Clariant believes collaboration is the best way to find the optimal solutions for the recycling challenge of its customers, increasing the attractiveness and functionality of post-consumer and post-industrial recyclate, and they believe that their initial partnerships are proof that working together works.

Clariant is set to reveal several further exciting collaborations and the sustainable products behind them as well as its plans for EcoTain at K 2019, October 16-23, Düsseldorf, Germany (Hall 8a Booth J11). Insights and updates are available ahead of the show at www.clariant.com/K2019.

‘Symphony of Collaboration’ plays a new tune towards sustainability Clariant’s new ‘Symphony of Collaboration’ is playing a new tune at K 2019, towards innovation and collaboration for sustainability and a circular plastics economy.

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Earlier this year, Anue Water Technologies launched its customizable geo-membrane products for the entire North American and Caribbean regions. Having already established itself as the leading manufacturer of high-efficiency Ozone and Oxygen systems for the elimination of odour, corrosion and FOG (fat, oil, grease) in municipal and industrial wastewater,1 this addition to Anue’s portfolio of offerings clearly maximizes on the company’s expertise in the area. We spoke to Anue CEO Paul Turgeon about the strategy behind the deal, the technology and its applications in the industrial setting for manufacturers of speciality chemicals.

The technology consists of high strength geo-membranes – very low permeability synthetic liners that control fluid migration. These geo-membranes are made from a proprietary material with superior tensile strength and chemical resistance, and they are fitted with pockets containing replaceable filter media. These activated carbon impregnated filters are breathable, allowing air and water to pass through while trapping the odour, and they are custom engineered to fit each application.

Such customization covers physical aspects, such as the shape of the structure containing the odourous wastewater, as well as chemical ones. These detailed specifications could be likened to the ‘secret sauce’ of geo-membrane technology, as the experts at Anue consider the chemistry behind each individual application.

“We use different manufacturing specifications for the speciality carbon filters, depending on the application”, explains Turgeon. “The media can be customized for particle size or extra ingredients, for example, to control particular odours and ensure exceptional broad-spectrum odour control.”

With an ability to remove all odours, including those from sulfide and ammonia build-up, which can be difficult to control, the geo-membranes can be used in practically any application. There has been a lot of early uptake in the food and beverage industry, for example, and geo-membranes are also being used as vent covers in the petrochemical industry to prevent noxious gasses from escaping.

“A lot of sectors – including some in the speciality chemicals industry – have very specific needs from a regulatory perspective,” says Turgeon. “If a plant has regulatory restrictions on what odours it can release, this can be a very specific goal, which can be addressed by geo-membrane technology.”

The geo-membrane technology greatly reduces labour touch and occupational health and safety risks, and it eliminates the need for costly chemicals or scrubber equipment. So much so, that it is reported to pay for itself within 6–12 months. Turgeon cited one real world example in the food and beverage industry, when a Fortune 500 company replaced a scrubber system at a site in Brazil and saved over $240,000 in one year.

The activated carbon filter media is changed every 6–12 months, after which they are simply put into solid waste or incinerated – no special disposal is needed. Carbon is not noxious and has no knock-on products as a result of incineration, so this approach is non-toxic and does not harm the environment. The current disposal method is tolerable, says Turgeon, at least for the time being.

“We’re already looking at more biodegradable materials,” he adds. “At the moment, the efficacy isn’t there, but we are actively investigating this and we’re hoping that in the future we’ll be able to make the systems even more environmentally friendly.”

The technology was first commercialized in 2011 and is already proven with use in 18 countries by major companies and municipalities.

“We’re getting a lot of interest with every application, and the word-of-mouth factor has been pretty impressive,” says Turgeon. “We’ve only had this technology in-house for about 6 months, but we have a significant pipeline of opportunities and an impressive market response.”

Of course, as the renowned experts in Ozone and Oxygen solutions, it is interesting to hear how Anue sees this new technology fitting alongside its existing Ozone and Oxygen injection systems for odour control.

“Sometimes the situational dynamics just don’t fit Ozone and Oxygen because it’s difficult to get power to the site, or because tanks are just holding stagnant materials,” Turgeon explains. “The geo-membranes can be used in remote locations that don’t need power. In the end, it just comes down to what’s the best fit for use and for customer economics.”

“The geo-membrane technology is simple but elegant,” concludes Turgeon. “And it means we have an extra service and product that meets a specific set of needs. It’s relatively early days for us, but we’re expecting the impact of geo-membranes to grow.”

References1. Turgeon P, Chandler T. Chemicals Knowledge Hub, 1st July 2019 (http://

chemicalsknowledgehub.com/article/water-treatment/view/ozone-and-oxygen-for-sustainable-odour-and-corrosion-control-/).

Odour control with geo-membrane systems Paul Turgeon, CEO of Anue Water Technologies, explains the technology behind geo-membrane systems, and how they can provide outstanding odour control in the industrial setting.

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Guaranteeing the supply of medicines is absolutely essential for ensuring patient health and wellbeing. Shortages of critical drugs such as those on the World Health Organization’s List of Essential Medicines can lead to dire consequences for patients that rely on these life-saving products. As such, drug companies must implement sourcing and manufacturing strategies that will ensure security of the supply chain and the continual, reliable delivery of high-quality therapeutic products regardless of unexpected events (natural disasters, equipment failures, raw material contamination, etc).

As a manufacturer and distributor of phyto and synthetic active pharmaceutical ingredients (APIs), C2 PHARMA faces numerous challenges to establishing a secure supply chain. We have therefore been highly proactive in implementing strategies designed to minimize and manage these challenges.

A key aspect of our strategy has been to develop and implement an innovative virtual manufacturing approach. C2 PHARMA does not physically own any manufacturing facilities, but contracts out all development, production and analysis activities to third-party service providers. We own our drug master files (DMF) or similar registrations filed with relevant regulatory authorities, and therefore have full legal responsibility for the appropriate manufacture of our drug products and the regulatory filings.

We live up to our responsibility of a virtual manufacturer by having quality oversight over our contract manufacturing organizations (CMO), beyond that which has been traditionally ‘standard’ in the industry. Our quality management system ensures full oversight of the entire manufacturing process from start to finish. Our change-management control processes prevent any process change from being implemented without prior review and written sign-off from C2 PHARMA. In addition, we carry out onsite reviews of batch documentation, QC data, risk assessments, and more.

The production of natural product APIs requires a variety of unique skill sets, including extraction using a variety of solvents, fermentation and synthetic chemistry. The equipment and technical capabilities involved for each of these processes are different, and rarely does any one CMO have expertise in all of these areas.

C2 PHARMA’s virtual manufacturing strategy enables us to choose the best and most reliable CMOs, with specialized capabilities that fit our needs for each individual API. We select only the most qualified CMOs after completing a comprehensive due diligence process that considers the technical ability and the safety, quality and compliance history of potential outsourcing partners at all stages from raw material sourcing practices to testing, manufacturing and product release.

The virtual manufacturer setup also affords C2 PHARMA tremendous flexibility and nimbleness; we are able to respond much more quickly to market or customer needs than would be possible with the corporate bureaucracy that accompanies large, traditional API manufacturers.

As a small to medium-sized company, outsourcing is also more cost-effective for us. We avoid the financial burden and pressure associated

with the high capital investment and operating expenses required to build/acquire and maintain a pharmaceutical production plant.

Even large pharmaceutical companies are leveraging the benefits of the virtual manufacturing model, particularly for mature APIs they want to maintain in their portfolios but for which they need to increase efficiencies and reduce costs.

Perhaps most importantly, the flexibility we gain by working with multiple CMOs in various parts of the world with wholly independent supply chains significantly enhances our ability to ensure security of supply for our APIs. If there are problems at one CMO, we can still provide critical drug products to our customers from another CMO.

As an example, C2 PHARMA currently contracts the manufacture of digoxin, a well-known, life-saving, microdosed API for the treatment of various heart conditions that is on the WHO essential medicines list. The production process is highly complex and requires continuous investment, focus and dedication. To ensure the secure supply of digoxin, we have developed a redundant supply chain, thus preventing shortages (previously a common occurrence) from happening in the future.

With CMO Laurus Labs in Vizag, India, C2 PHARMA invested more than US$10 million in a dedicated, cutting-edge production facility and supply chain for digoxin. In this case, we own the physical infrastructure, but the day-to-day operations, quality control and assurance, testing and product release are managed by the CMO. Investment in the infrastructure was made to guarantee the supply of digoxin long into the future.

C2 PHARMA also acquired the digoxin API product portfolio of the Polish company Nobilus Ent, which was self-developed and inherited from Roche/Galenus Mannheim. Nobilus will continue to be our manufacturing partner and releasing entity for this API.

Each of these CMOs relies on a separate supply chain of leaves, enabling C2 PHARMA to ensure a unique and redundant supply of digoxin API. Both the European and Indian sites have been audited by regulatory authorities in the US, Europe and Asia.

Leveraging virtual manufacturing to build secure supply chainsJames Lawler, Head of Quality and External Supply Operations at C2 PHARMA, explains how the implementation of virtual manufacturing strategies can ensure supply chain security and the reliable delivery of high-quality therapeutic products.

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Author: James Lawler, Head of Quality and External Supply Operations at C2 PHARMA, 270, Rue de Neudorf, L-2222, Luxembourg, Grand Duchy of Luxembourg T: +352 28 26 11 00; E: [email protected]



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Considering the recent news items related to carcinogenic impurities in various Sartan’s from Asian sources, what has been your company’s response as an API supplier given the discovery that perhaps synthetic chemistry issues were not taken into account sufficiently when processes were changed?That’s a very relevant question and one that CordenPharma takes very seriously. We continue to see the effects of this recent “Sartan” scandal ripple through the industry as the investigation now widens to other families of molecules that potentially could also have similar challenges.

I have not seen any updates from the FDA recently around exactly what happened in this particular situation, but it appears that a seemingly trivial process solvent change was at the heart of the problem, which was then further impacted by poor impurity profile monitoring and ultimately data integrity issues.

What is unclear at this time is whether the process change was adequately investigated at the initiation of the change, and that appropriate controls were put in place and ignored, or whether the change was just simply not fully assessed at the start. I hope that ultimately the FDA releases more information on this situation, because the industry needs to learn from these mistakes and obviously improve.

With specific respect to CordenPharma in this situation, at this stage we are not changing anything or introducing any new procedures at our facilities, as we believe we already have a very robust change control process. We understand that when it comes to our customers’ APIs, we are the scientific experts with the most knowledge about the process. It is our responsibility to therefore appropriately assess proposed changes via a robust change control process and advise our customers about what precautions need to be taken and which studies may need to be completed before process changes are implemented.

As a CDMO however, this can often put us in a difficult position, as some customers may not fully understand the potential risks or may not want to delay changes while the appropriate studies are completed. What unfortunately complicates the situation further is the matter of costs.

Any proposed changes to the process are communicated in advance to our customers, including full involvement of appropriate approvals. Their level of involvement can obviously change depending upon the scientific depth and bandwidth of the customer, but generally we like and encourage our customers to be as involved as possible.

The challenge comes if the enforced changes, which sometimes occur absolutely outside of our control, incur un-budgeted costs for our customers. Whenever possible, we obviously work with them on these issues. However, we have an obligation to the end users – the patients – to ensure this work is completed, and that we are ultimately producing safe products for the market place.

Having said that, we need to strike a balance. At CordenPharma, we supply APIs to customers in all stages of development, from early Phase I supplies through to commercial supply of approved drugs in the market place. Our approach needs to take into consideration the phase of the product and the intended use so that we can tailor phase-appropriate solutions.

As expected, we often experience pressure to keep costs down by using Asian sources for raw materials. In fact, as a CDMO we are almost always in a competitive bid situation and being compared to our CDMO peers, who are also using Asian sources, so it is difficult for us to do anything else – we ultimately need to be competitive in the marketplace to survive.

The use of Asian sources in the early phase of development can obviously offer significant cost savings to our customers, but as we move through the development phases, this approach can sometimes seem “penny wise and pound foolish” when challenges start to manifest themselves. Challenges with Asian raw material sources include:• Sudden process changes leading to quality issues• Changes in manufacturing sites or sudden plant closures• Finding out that who you thought was the manufacturer turns out to

be an agent all along.

These sorts of unexpected variables always show up at the most inopportune times, and can lead to very impactful situations such as requiring the qualification of new sources, repeating of process validation batches, reconsidering fate and purge studies, all of which can impact submission timelines, ultimately delaying regulatory approvals and adding extra costs not planned for in the original budgets. These are the factors that pharma customers are often not considering when they initially insist on the use of cheaper Asian sources for raw materials or resist proposals to introduce alternative sources through the development cycle.

When discussing Asian supply chains, how does CordenPharma address these concerns?Obviously, we need to be competitive in the marketplace, so we have to consider using Asian raw material suppliers for those initial early-phase manufacturing runs. However, wherever possible we will use vendors that we are familiar with and have used before – that would be our ideal situation – but clearly that is not always possible.

As our customers successfully move further along the clinical process, we encourage them to introduce multiple sources of raw materials so we can build contingency into the supply chain. We also start to increase the Quality and Compliance oversight of these suppliers by conducting on-site audits of these vendors, especially as we approach Phase III supplies and process validation activities. But all of these

Managing Asian Supply ChainsDr Stephen Houldsworth, Vice President, Global Head of Platform Management & Marketing at CordenPharma International, discusses current challenges with global supply chains in this insightful interview.

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Dr Stephen Houldsworth

Continued on page 50 ➦

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approaches require time and money – two scarce resources that our customers often limit or have not planned for in their timelines and budgets.

As a case in point, we are helping to navigate one customer’s project through a difficult situation. Their CMC & Clinical team had submitted a timeline and budget to their upper management which didn’t correspond to our estimates of timeframe or project costs. Now both groups are scrambling to get things done on time within the limits of their budgets.

The takeaway here for pharma and biotech customers is that instead of just considering your CDMO within the confines of a contractual relationship, invite them into your planning stages, seek their input, and strategize together as trusted partners on how to achieve your goals. We have seen this process save significant time and money for our customers down the road.

Perhaps CordenPharma’s biggest differentiator on the topic of Asian supply chains is our sister company Weylchem. CordenPharma and Weylchem are both owned by the International Chemical Investors Group (ICIG), which was founded in 2006 with the vision of building a privately-owned global industrial conglomerate covering non-GMP chemical production (WeylChem), and chemical pharmaceutical cGMP manufacturing services (among other businesses), the latter being formed into the CordenPharma umbrella platform. Through this non-GMP manufacturing network, we produce some of the more complex regulatory starting materials that, when otherwise sourced from Asia, often lead to major challenges.

The advantages of accessing the Weylchem group are that they operate under Western standards for quality, environmental controls, safety, business ethics and confidentiality, and since CordenPharma and Weylchem both have sites located in Europe and the US, the logistics and delivery of raw materials are greatly simplified.

Furthermore, because we have greater visibility and insight into the operations at Weylchem, we can be assured that there are no surprise

process changes or site modifications at the last minute that would cause a delay in a filing. Also, it is very easy to share analytical methods within our transparent network – so the chance that a lot of raw material is going to show up at one of our facilities that fails specifications, and thus delays a production run, is non-existent.

How does price factor into these decisions?Although manufacturing raw materials in a European setting is more expensive than purchasing from an Asian source, what is the cost associated with a delay to an approval or day 1 launch due to a submission deficiency which is related to a regulatory starting material?

These costs are harder to visualize for our customers and, unless they have experienced them in the past, are more easily trivialized or minimized. However, they do happen – more often than you would think.

Today the CDMO industry is being constantly pressured to delay what might be considered unnecessary expenses as customers scramble with inadequate budgets to complete the earlier clinical milestones. However, the drug developers need to understand they are often just putting off the inevitable situation – sometimes paying a slightly higher price upfront can save significantly down the road in terms of time and money.

These issues can be addressed or mitigated at an earlier stage by paying closer attention to the full supply chain, and by perhaps spending a little more on the overall API budget to secure raw materials from a Western source, especially when considering some of the more complex regulatory starting materials and their possible challenges if comparatively sourced from Asian suppliers.

Formed as the global pharmaceutical service and manufacturing platform of International Chemical Investors Group in 2006, CordenPharma is a full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products, and associated Packaging Services. www.cordenpharma.com

➥ Continued from page 48



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Earlier this year, the new contract development and manufacturing organization (CDMO) entity Seqens was formed, combining subsidiaries Novacap, PCI Synthesis, PCAS, Chemie Uetikon and Proteus under one new banner. As the rebranding rolled out across the group’s 24 manufacturing plants and three R&D centres in Europe, North America and Asia, the move positioned Seqens as an integrated global leader in pharmaceutical synthesis and speciality ingredients. We spoke to Frederic Desdouits, Managing Director CDMO at Seqens, to find out more about the strategy behind this consolidation, and the group’s achievements so far.

What was the rationale behind the consolidation and re-branding? We acquired a series of well-known and respected CDMOs: Chemie Uetikon in 2015, PCAS in 2017 and PCI Synthesis in 2018. This strategic move was to create a network of high-quality service companies competing with one another in a very fragmented market. Our aim has been to merge the capabilities and competencies of those groups into one unique offering. It was then natural to rebrand it under one name, Seqens CDMO.

So was the intention to build an integrated company by combining several specialists? We certainly don’t see being more global and remaining specialized as mutually exclusive. With our current network, we have a global reach with R&D facilities, and GMP and preGMP production sites, in Europe and USA. We can offer our clients a back-integration strategy by internally producing preGMP intermediates and we can also offer two sites to produce their assets and, hence, provide a back-up strategy. At the same time on the specialization front, we keep on investing in our existing technologies, as well as new technologies and differentiating features.

How do you maintain consistent quality and service across 24 plants across the world?Seqens is organized by independent Business Units supported by strong corporate functions.

The quality system is managed through a global organization under the control of our Quality Director, who reports to our CEO. All our on-site quality organizations directly reporting to this global organization, and indirectly to the Business Unit organization. Thus, we have a global critical mass in quality at the group level.

Services are provided by the Business Units where the commercial, R&D and project management teams are located. At the Business Unit level, we are fully empowered to run our business and decide on how to best serve our clients. Obviously, we also interact between Business Units to better serve clients who work with different Seqens Business Units.

Do you see your individual facilities collaborating more, now that they share a common identity? Renaming the company and having everyone working under the same brand clearly created a new atmosphere. Seqens made eleven acquisitions in 7 years, and recently acquired PCAS which itself was built through a series of acquisitions. The time was right to create a different momentum and to show the teams we are all playing with the same shirt. The impact is currently more visible in the support functions and the management teams than in the manufacturing sites, which have less trans-facilities activities. Nonetheless, I recently noticed several initiatives to share best practices between CDMO sites – in particular in quality, operational excellence and supply chain management.

Looking back over the past year, what is the group’s greatest achievement so far, in your view?We were able to keep the momentum going while asking teams to change their habits and work together, which often means putting aside personal egos! Overall, we had very good feedback from our internal teams, and a recent client survey shown us than clients also understand our move and strategy. The CDMO Business Unit was set up in April 2018, so this level of internal and external recognition in just over a year is a great achievement.

Q: Thinking about the consolidation process, is there anything that you would have done differently, if you had the time again?Go faster! (If possible.)

What’s next for SEQENS?Next, we will be accelerating our development in the main three geographic zones (Europe, USA and Asia). The market is extremely competitive, and we need to remain at the best level of service. To this end, we have reorganized our salesforce team and we are reinforcing our project management processes and team.

I believe we are showing good skills in consolidating CDMO players with very different histories and models. This could become attractive to small players willing to gain scale and critical mass without losing their critical features and culture.

Consolidating while keeping momentum Frederic Desdouits, Managing Director at Seqens CDMO, tells us more about the strategy behind the group’s recent consolidation and its achievements so far.

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Frederic Desdouits, Managing Director at Seqens CDMO

Interview with: Frederic Desdouits, Managing Director CDMO at SEQENS, 21 Chemin de la Sauvegarde, 69134 Ecully Cedex, France T: +33 (0)4 26 99 18 00; www.seqens.com



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Processing industries are finally catching up to service industries in their digitalization efforts. However, chemicals continue to trail when compared to others in its own class, according to a recent McKinsey report entitled Mapping heavy industry’s digital-manufacturing opportunities.1 Many chemicals operators are lagging behind in implementing digital solutions – and therefore missing such advantages gained from advanced process control (APC) capabilities that enable units to run at faster rates and deliver consistent on-spec products. Many are yet to trial analytics tools that can help them apply lessons from previous operations to improve future outcomes.

Operators will need to take action soon to address this and kick-start their digital efforts. Otherwise, they will miss out on the opportunities moving to digital could bring – from the chance to drive up productivity and profit through enhanced throughput and yield to the opportunity to achieve predictive maintenance to help ensure continuous operations and enhanced safety.

It is all about the pursuit of operational excellence. APC still plays a key role in helping companies to continuously maintain optimal operating conditions, while using prescriptive analytics to pinpoint when a piece of equipment will fail allows operators to plan ahead, develop contingency plans and make cost savings.

Given these potential benefits, why aren’t more chemical operators taking advantage of digitalization? Complexity is the most common refrain I hear from chemicals companies. Many operations, particularly in specialities, have become increasingly complex as customer performance demands grow and product lines must diversify to meet them.

Putting a plan in place Chemicals production involves thousands of different processes that are used to make tens of thousands of products on a wide variety of asset types, and often across several geographic regions. In this environment, it is wrong to imply that quick and simple solutions are readily available. Digitalization efforts take time but the experiences of AspenTech customers overwhelmingly prove the value of the effort. Increasingly today, digitalization is not just an option for chemical operators, it is a strategic necessity.

So what works in practice? How can chemical operators move beyond a theoretical appreciation of the benefits of digitalization and instead start implementing solutions on the ground to drive enhanced profitability and competitive edge? Here we outline some key steps to take: from enterprise-wide planning to the development of internal specialists to make sure digital transformation efforts are a complete success.• Prepare your organization: Many companies struggle to find the

resources to execute digital projects, and efforts often get stalled by competing priorities. BASF sees the importance of fast action for Industrie 4.0 projects, and has created a separate organization, isolated from IT, to push the implementation. At INVISTA, an

integrated fibre, resin and intermediates company headquartered in Kansas, USA, the concept of ‘citizen data scientists’ is used to encourage employees to get involved in analytics projects that identify preventative and prescriptive actions to resolve production issues.

• Develop internal specialists: ExxonMobil uses a team of internal experts to implement APC technologies at its olefins/polymer complexes across the globe. The experts travel to each site to implement and troubleshoot and, using the latest capabilities of Aspen DMC3, have been able to reduce implementation periods to 6 weeks from 6 months or more previously. Braskem has identified internal change agents that use entrepreneurial thinking to encourage adoption of new digital tools throughout their businesses.

• Incorporate digitalization in your sustainability plan: Digital solutions have always targeted improved efficiency and reduced use of resources, which are common goals in sustainability programs. Several companies are integrating digitalization into their corporate sustainability efforts, from Germany to Saudi Arabia to Canada, with a focus on changing the metrics used for tracking production processes. Companies are moving from purely financial metrics to alternatives such as carbon dioxide emissions and total resource efficiency to target employee actions and engagement at the broader impacts of operations.

At a recent industry event in Mexico, an audience member asked me, “Is digital a fad – something that will go away and no longer have meaning for my business?” I responded with a resounding, “Definitely not.” I do not see a future where companies no longer depend on the control and optimization capabilities that have been delivered by digital solutions on assets around the world.

The market landscape is likely to remain complex and difficult to navigate - but that must not stand in the way of chemicals operators. If they want to reap the many rewards on offer, they cannot afford to delay. If they want to avoid leaving money on the table and being left behind by their rivals, they must cut through this complexity and urgently start their journey. The efforts demand focus but the payoffs make it well worth the effort.

Reference:1. Noterdaeme O et al. McKinsey.com, September 2018.

Why digitalization is worth the effort for chemicals operatorsPaige Marie Morse, Industry Director at AspenTech, explains how chemicals manufacturers could benefit from implementing digital solutions with advanced process control capabilities that enable units to run at faster rates and deliver consistent on-spec products.

Digitalization

Author: Paige Marie Morse, Chemicals Industry Lead at Aspen Technology Inc, 20 Crosby Drive, Bedford, Massachusetts 01730, USA T: +1 281 584 1000 E: [email protected]

18 – 19 November 2019Leonardo Royal Hotel London Tower Bridge, UK

The top leaders in Pharma are coming to an event that will shape the future of the industry. And you’re invited.

With more than 350 senior industry executives, 90 prestigious speakers,and 7 years of successful events behind it, Pharma Integrates 2019 is where the leaders

of Pharma share the conversations that help to shape its future.

Life Science Integrates, the producers of the debate-led events shaping the Pharma and Biotech sector,invite you to attend this year’s conference.

Register now to secure your early bird discount and to network with our high-pro�le speakers.Attend both days to hear our panels’ insights into the issues and trends affecting the industry.

With dedicated networking sessions throughout the day providing an opportunity to engage with theseexperts, we together, as an industry can collaborate, innovate, and shape the future of Pharma.

REGISTER NOW TO MEET, LEARN FROM,AND NETWORK WITH THEM.

LifeScienceIntegrates.com/pharma-integrates

Presented by

OUR SPONSORS INCLUDE

CONTINUED GROWTH FOR EIGHTH EDITION

OF PHARMA INTEGRATES



18 – 19 November 2019Leonardo Royal Hotel London Tower Bridge, UK

The top leaders in Pharma are coming to an event that will shape the future of the industry. And you’re invited.

With more than 350 senior industry executives, 90 prestigious speakers,and 7 years of successful events behind it, Pharma Integrates 2019 is where the leaders

of Pharma share the conversations that help to shape its future.

Life Science Integrates, the producers of the debate-led events shaping the Pharma and Biotech sector,invite you to attend this year’s conference.

Register now to secure your early bird discount and to network with our high-pro�le speakers.Attend both days to hear our panels’ insights into the issues and trends affecting the industry.

With dedicated networking sessions throughout the day providing an opportunity to engage with theseexperts, we together, as an industry can collaborate, innovate, and shape the future of Pharma.

REGISTER NOW TO MEET, LEARN FROM,AND NETWORK WITH THEM.

LifeScienceIntegrates.com/pharma-integrates

Presented by

OUR SPONSORS INCLUDE

CONTINUED GROWTH FOR EIGHTH EDITION

OF PHARMA INTEGRATES



Ahead of Siemens’ Digital Talks conference earlier this year, I took the opportunity to talk to two senior executives from FUJIFILM Diosynth Biotechnologies, one of the world’s leading providers of contract process development and manufacturing services for the biopharmaceutical industry.

Initially, our conversation was focused on where FUJIFILM were on the digitalization journey today. They were very honest in their response, describing how much of their R&D and manufacturing processes were still generally “islands of excellence, automation and data management”, and that they were working hard to bring all of these together.

As a CDMO specializing in the delivery of recombinant proteins, viral vaccines and gene therapies, they combine technical leadership in cell culture, microbial fermentation and viral vectors with world-class GMP manufacturing facilities. This move towards a more connected and optimized way of working was seen as being vital as the company moved from ‘Big Pharma’ to ‘Smart Pharma’, and they explained how customers within key sectors such as clinical trials now demand smaller, bespoke batches quicker than ever before. Agility, speed and flexibility are also required to meet the increasing demand for more personalized medicines, with very targeted commercial products being developed for smaller and smaller groups of patients.

Drilling down further into how this more responsive and efficient way of working can be achieved within a pharma setting, FUJIFILM described the challenge of shifting its emphasis from the performance of highly automated equipment into the active management of performance data that comes out of the production line.

Kit that continues to “spit out information into a spreadsheet or into a database” is being calibrated to bring all the data together, and the performance from their process development laboratories – and details of what’s happening in our GMP manufacturing being combined – is going to give them the opportunity to speed up their processes further and produce even higher quality medicines.

While it was agreed that increased data gathering and data analysis lie at the heart of this move towards smarter pharma manufacturing, and that the technologies required to do this were already in the marketplace, FUJIFILM also said an area which could potentially be a barrier to rapid adoption was the appetite for change within the workforce. While colleagues had expertise, knowledge and an understanding of value of data, and could see the vital role they had to play in the wider production process, trying to get that link together across the full businesses can be challenging.

The crux of the matter was about making it personal to their people. This includes how to better communicate the benefits of more interconnected practices; highlighting how it could help their colleagues, customers and future patients by ultimately by doing something different with the information they have to hand.

On that point they said: “The people who are actually doing the experiments in the labs, who are doing the quality stability work, that are manufacturing GMP batches, they have a large voice to play because a lot of the issues that they see, the solutions and the revolution of the digital world will help make it more efficient.”

FUJIFILM also explained how this embracing of new ways of working, driven by Industry 4.0 technologies, is also impacting on their supply chain and end user customers. Some of their bigger customers are very advanced in their digital journeys and are now demanding data in certain formats and certain structures from their suppliers.

However, one the real challenges is that digitalization of the supply chain isn’t harmonized, meaning there are different demands and unique issues with different customers.

At the other end of the spectrum for example, working with smaller biotech companies, FUJIFILM said there is much more fragmentation, and as a result were trying to develop a system that is able to flexibly respond to those who had very aligned needs to their business and simultaneously work efficiently with those who weren’t.

What I took away from this fascinating discussion was the fact that even a highly advanced, world-leading and innovation-led pharma business like FUJIFILM Diosynth Biotechnologies is wrestling with the adoption of digitalized processes with regards to its staff, customers and the wider supply chain. This is also why, as manufacturers ourselves, Siemens believes that the transformational Industry 4.0 journey is one that we all need to take together.

You can watch an edited version of my interview with FUJIFIM at www.tinyurl.com/siemensfuji

Connecting ‘islands in the stream’ Alwyn Jones, Siemens Digital Industries Head of Pharmaceutical and Life Sciences UK & Ireland, explains how FUJIFILM Diosynth is embracing Industry 4.0.

Digitalization

Alwyn Jones, Siemens Digital Industries Head of Pharmaceutical

and Life Sciences UK & Ireland

Author: Alwyn Jones, Siemens Digital Industries Head of Pharmaceutical and Life Sciences UK & Ireland T: +44 (0) 7808 823346 www.siemens.com



Two 2020 Events for the Specialty Chemical Industry

www.chemicalsamerica.com

Belmond Charleston Place

Charleston, South Carolina

July 28-302020

Omni Fort Worth HotelFort Worth, TexasFebruary 10-12

2020

Rescheduled Show Dates



WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver ground breaking treatments to patients. Founded in 2000, the company now has over 30 sites globally, where it employs more than 19,000 people – half of whom are women. Sarah Harding spoke to four of them, to hear their thoughts on working in the pharmaceutical industry in the 21st century.

The importance of mentorshipHaving broken the proverbial ‘glass ceiling’, these women are great role models for other young people entering the pharma industry. So it was good to hear that they all now mentor young people themselves, either formally or informally.

As noted by Yu Lu, Vice President of Business Operations at WuXi STA, “WuXi’s work force is generally very young. I have developed close relationships with many young women who I work with and consider myself as an advocate for them as much as I can.”

“I always see it as my duty to raise new talent,” agreed Gundel Hager, Managing Director at CRELUX. “I participate in various university and non-university programs to mentor young scientists. I am a certified trainer for biotechnicians and, if my time allows, I actively participate in the training of the young generation, especially in the area of successfully combining career and family.”

Xiao-Ping Dai, Vice President, Process & Technology Development, Chief Technologist at WuXi Advanced Therapies, believes that “Helping young people develop is a career goal for me, from which I can derive great personal satisfaction. Helping young people succeed also strengthens our organization and improves effectiveness.”

This commitment to helping young people may stem – at least in part – by the strong role models these women had themselves, early in their own careers. They were effusive in the praise of the people who had encouraged them to be confident, ask questions, and make the most of the opportunities presented to them. In years past, many men and

women encouraged our panel by setting good examples and impacting their lives for the better. Numerous characters were mentioned by name and discussed fondly.

And if remaining in someone’s thoughts as an inspirational memory isn’t sufficient incentive for you to take on a mentoring role yourself, perhaps this additional comment will induce you to consider encouraging your younger colleagues to make the best of themselves.

“I routinely tell my newer managers who are looking for openings to the next level of leadership that they must first open doors for their team to step into, in order for the doors above them to open,” one of our panel members said. “When you have a successor ready to take your place, it is then that you are ready to occupy a new place on your own career path.”

Challenges overcomeAlthough they were fortunate to have the encouragement from key people in their lives, there were still challenges to be overcome on their ways up the career ladder.

“As a woman,” said Xiao-Ping Dai, “perhaps we need to not only be twice as good but also do twice as much… and it can be even more challenging as an Asian woman.”

Gundel Hager agreed, saying “My experience taught me that one has to be multiple as good in order to achieve similar career goals as male colleagues.”

Nevertheless, most of the panel agreed that the situation for women in the workplace has improved in the 21st century.

“I think it is easier for women to progress their career today than 15 or 20 years ago,” said Yu Lu, who is the mother of two daughters. “Looking back the toughest years in my career path were the first few years after my younger daughter was born. I was physically and mentally exhausted all the time. As my daughters grew older I gradually found myself again! There is a much more mature childcare support environment in the society today than 20 years ago, and there are many more well-respected women leaders in every aspect as a consequence.”

“We have seen more and more women taking important leadership roles today than ever,” added Jinling Chen. “There has been a gradual culture change that makes it more acceptable for women to be leaders.”

Jinling Chen noted that the gender challenge appeared quite late in her career path. “I did not feel the difference career wise as a student, a scientist, and even in middle level management positions. However, I did see that it is more difficult for women than men advancing to senior leadership roles. Some had difficulties to believe in woman’s ability to understand complex issues and to make decisions decisively, even when we have a strong track record to demonstrate ourselves.”

Breaking the glass ceilingWe spoke to four leaders of research and business operations at WuXi AppTec to discuss their views on Women in Science in the 21st century.

Women in Science

Yu Lu, Vice President of Business

Operations at WuXi STA, a WuXi AppTec company

Xiao-Ping Dai, Vice President of Process & Technology Development, Chief Technologist at WuXi

Advanced Therapies, a WuXi AppTec company

Gundel Hager, Managing Director,

CRELUX GmbH, a WuXi AppTec company


www.chemicalsknowledgehub.com Women in Science

Industry benefitsIt is important that women are encouraged to reach higher levels of management – not just for the moral arguments of equality, but also because they bring particular skills to the table, which offer added value to the companies that employ them.

Xiao-Ping Dai was very clear that, “Most women leaders are hard-working individuals and have strong emotional intelligence. If they have an ‘added value’, on top of technical expertise, it is the ability to understand people better.”

The other panellists appeared to agree, echoing this sentiment in their own ways.

“In general women are more ‘sensitive’, which means they tend to pay more attention to the needs of the people around them, whether that’s a colleague or a customer,” said Yu Lu. “Women also tend to have stronger analytical skills and pay more attention to details.”

“Often, women turn to be good listeners,” said Jinling Chen. “It helps us to understand others in a deeper level and allows us to bring the best out of everyone. It is good for building a cohesive team. Women also tend to pay more attention to the need of our end users – the patients.”

“Women are great team players and communicators and, in combination with the multiple as good professional competence, they will drive their teams to success,” agreed Gundel Hager.

Another factor that emerged during this discussion was ego. It was suggested that perhaps one advantage women bring is that they don’t typically require as much credit or recognition for the support they offer. However, this can be a two-edged sword. The suggestion that women don’t always require or demand the recognition for their successes could be indirectly related to how senior positions end up predominately filled by males. Perhaps women need to advocate for themselves a bit more.

Advocating for ourselvesThis will be a familiar theme for anyone who has attended a women’s networking event. Most women’s natural tendency is towards modesty

for their achievements, but we need to learn to ensure that those achievements are recognised and rewarded – not just for ourselves, but for those around us too.

“All women should confidently seize opportunities and move ahead without fear,” advised Gundel Hager. “When it comes to self-marketing, women are allowed to put on a little more weight; too much modesty can make them lose chances.”

“Women need to speak up and stand up for themselves in the work place,” agreed Yu Lu.

“We must believe in ourselves, continue learning, and empower ourselves and people around us,” added Jinling Chen.

ConcludingSome challenges remain for women in the workplace but our panel is living proof that advances can be made with the right support and encouragement, and in the right environment. Certainly, our four panel members all believe that WuXi AppTec is dedicated to opening opportunities for both women and men.

“WuXi is a recognized leader in our industry and has been growing at a fast pace for years which created many growth opportunities for women and for men working here,” said Yu Lu. “My own career path at WuXi is a great example. I joined STA, a subsidiary of WuXi AppTec, 7 years ago, in a business development role. As STA’s business grew steadily, there was a need to set up many new functions which were never existed before. I took on the challenge and started to set up one new function after another. Today, I lead a wide range of business and operational functions. I’m honoured to be part of a team including many great women leaders in both technical and business field. The leaders at WuXi are chosen and further developed based on his/her ability, not gender.”

“At WuXi all employees get the same chances – it is the qualification and leadership that drive the success,” agreed Gundel Hager.

“WuXi provides women leaders room to grow their careers. The senior leaders are open minded in promoting women leaders to the C-suites,” added Xiao-Ping Dai.

However, women need to help themselves – and each other – to ensure that their achievements are recognised and rewarded with career progression.

“Women can be great leaders and, in combination with many good professional competencies, they can drive their teams – on every management level – to exceptional performances,” said Gundel Hager.

“Dream big, and embrace it,” concluded Xiao-Ping Dai.

I think we could all benefit from taking that advice.

Jinling Chen, Vice President of Pharmaceutical

Development at WuXi STA, a WuXi AppTec company



Liz Rowsell joined Johnson Matthey (JM) in 1993 as a Research Scientist, after completing her PhD in Chemistry at the University of Essex (UK). We spoke to Liz about her career, her current role as Corporate R&D Director, innovation and her thoughts on being a ‘woman in science’.

You began your career at JM as a Research Scientist – what drew you to the company, and what projects did you work on? I was always interested in biological/medicinal chemistry and heard that the JM Biomedical Group had openings for someone to work on ruthenium chemistry. I was aware of JM from their metals loan scheme, which allowed academics and students access to small amounts of platinum group metal to perform their research. I was interviewed at the Johnson Matthey Technology Centre and was immediately excited by the prospect of applying my science to make a positive impact.

I began working on understanding the role of nitric oxide as a chemical messenger in the body, and its role in the progression of sepsis. It was a fabulous project to be given as a young scientist, allowing me to travel and work with an amazing team.

When I look back at the younger me, I was ambitious, but was always very self-aware. I was not afraid to decline a role that I did not believe was right for me, or that I did not feel I was right for.

In your current role, you are responsible for ensuring that JM meets its objectives for R&D, and for improving existing products. How do you decide where JM should focus its R&D efforts?I work closely with my technical and commercial colleagues in our businesses and with our Group strategy team. We strive to understand our customers’ needs – today and in the future – in what is a very complex world.

Part of my role is to build the technical capabilities that will help JM maintain a competitive advantage, but also to consider the

capabilities and skills we will need to take us into our third century. Scientists are naturally curious and will always want to know more, so sometimes the hardest thing is knowing when to stop.

How important is collaboration with other private or public entities in achieving scientific progress?It is essential. We are a collaborative organization, we work with customers, universities, trade associations and learned bodies. Innovation is an iterative process; you build on knowledge and expertise to create value from your science. The concept that science has no barriers is only viable if you actively reach out and work collaboratively. It is often easy to be insular, which can make it harder to take the initial steps to reach out to others. However, it is far more rewarding if you work collaboratively in the long run.

Britain has top class talent in academia and industry, but innovation is not subject to geographical boundaries. We must ensure that we are able to work with our colleagues wherever they are based, to invent and create technology that has a positive impact on our world. Legislators and leaders have a key role in listening and enabling scientists to work together for value creation.

Being a Member of Innovate UK’s Advanced Materials Leadership Council must keep you at the cutting edge – where do you think the most promising opportunities lie? I have enjoyed my involvement with the Advanced Materials Leadership Council, working with colleagues across sectors to understand our strengths in advanced materials and the actions needed to enable the UK to create the right framework to maximize R&D investments.

I think the most promising opportunities often arise from disruption, or at the interface of disciplines. JM is actively creating opportunities through applying material science in the evolving automotive power train with our work

Driving innovation in a complex worldLiz Rowsell, Johnson Matthey’s Corporate R&D Director, shares insights into her 26-year career at Johnson Matthey.

Women in Science

in emission control catalysis, battery materials and fuel cell technology. Transport is changing, and the appropriate solutions will be driven by geography, consumer needs and environmental impact. At JM, we are applying our cutting-edge science to provide material solutions that enable our customers to make a real difference to the world around us.

I am also intrigued by the opportunities that present themselves for chemists who are fluent in biology, physics and software science at a time when digitalization and the drive to understand the impact we have on our planet is imperative.

In the modern world, it is rare to find someone who has stayed with one company for their whole career. How has JM managed to retain you for 25 years? I think it is simple. I have been allowed to be creative and responsible for my own actions, the science is fascinating and has real impact, and I work with genuinely decent people.

What does Dr Rowsell say about being a ‘Woman in Science’?“You must start to engage women in science at a very early age. Seeing women in senior science roles and leadership positions is the only way younger female scientists will believe it is the norm for them and entirely achievable.”



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A NEW NAME BACKED BY 75+ YEARS OF EXPERTISE Comprising of SK biotek Korea, AMPAC Fine Chemicals and SK biotek Ireland combined to enable the provision of the highest quality services to our customers.

• Sites across the globe• 1000m3 of global capacity• 3 R&D Centres• 1 Analytical Service• Energetic Chemistry• Continuous Flow Process• High Potency• Controlled Substances• Particle Engineering

5 – 7 November 2019 | Frankfurt, Germany

HALL 10.1 STAND A30COME VISIT US

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A NEW NAME BACKED BY 75+ YEARS OF EXPERTISE Comprising of SK biotek Korea, AMPAC Fine Chemicals and SK biotek Ireland combined to enable the provision of the highest quality services to our customers.

• Sites across the globe• 1000m3 of global capacity• 3 R&D Centres• 1 Analytical Service• Energetic Chemistry• Continuous Flow Process• High Potency• Controlled Substances• Particle Engineering

5 – 7 November 2019 | Frankfurt, Germany

HALL 10.1 STAND A30COME VISIT US

USA | Ireland | Koreawww.skbiotek.com | [email protected] | [email protected]

pharma - chemicals knowledge hub · 2 october/november 2019 editorial sarah harding, phd editorial...

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