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Where industry connects to share new ideas andinnovations across all phases of bioprocess development

Inform, Innovate and Connect

Tuesday 14 - Wednesday 15 April 2015 • Swissôtel Düsseldorf Neuss, Germany

E U R O P E A N S U M M I T

11TH ANNUAL

Managing Quality acrossManufacturing Networks

Dr Anthony Mire-Sluis, Amgen

Low Cost, High VolumeManufacturing

Dr Rahul Singhvi, Takeda Vaccines

Supporting the FDA’s“Breakthrough Designation”

Dr Niklas Engler, Roche

Flexible CMC and ContinuousProcessing

Dr Jens Vogel, Boehringer Ingelheim

Future ManufacturingTechnologies

Dr Roman Necina, Baxter

Driving out Inefficiencies

Dr Craig Smith, Thermo Fisher

Future of Biomedicines

Dr Günter Jagschies, GE Healthcare

Keynote Speakers

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ADCs, Novel Therapies and Biosimilars

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Cell Culture, Upstream Processingand Process Analytics

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Downstream Processing andContinuous Manufacturing

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Manufacturing, Single-Use andQuality Management

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Analytics, Quality Control and Formulation

www.bpi-eu.com

Associate Sponsors

Corporate Sponsors

FLASHPRICE

£999T&C apply

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Inform, Innovate and Connect

April

2015

14-15 This 48-hour investment couldimpact your whole year, evenyour career. Now that is an ROIany manager can sign off.

The 2015 BioProcess International Europe SUMMIT is more than just a conference, it’s a time topause and reflect on the critical challenges facing the production, quality and analysis of biologics;an opportunity to challenge conventional thinking and work as an community to prepare for thenext wave of products, processes and technologies shaping the future of your industry, yourcompany and ultimately, your career.

Media development and control

Testing for Pluronic

Scaling up and down

Implementing continuous processing

Finding new purification steps

Purifying novel formats

Evaluating commercially viablealternatives to protein A

Serving local markets

Evaluating SUS reliability

Designing new facilities

Interpreting FDA ContractManufacturing Guideline

Working with external partners

Characterising impurities

Managing supply chains

Finding newcollaborators

EvaluatingCompetitors

Evaluating newtechnologies

Answering the needs of thebioprocessingcommunity

Meeting keydecision-makers Reducing

manufacturingcosts

Accelerating downstream processing

Speed tomarket

Ensuringproductquality

Working withclosed systems

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07.30 Registration and Morning Coffee

08.20Chairperson’s Opening Remarks

08.30Managing product quality across an increasingly global manufacturing network, Dr Anthony Mire-Sluis, Amgen

09.10 Innovation that drives process efficiency, Craig E. Smith, Ph.D, Thermo Fisher Scientific

09.50Experiences and strategies to support projects with FDA breakthrough designation for biologics, Dr Niklas Engler, Roche

10.30 Morning Coffee and Start of partneringONE

Preparing for Future Patient Needs17.35 Challenges and opportunities in vaccine manufacturing, Dr Rahul Singhvi, Chief Operating Officer, Takeda Vaccines

18.05 Future of biomedicines, Dr Günter Jagschies, GE Healthcare

18.35 Closing Remarks

18.40 Networking Drinks and Canapes followed by Wine Casino

AGENDA AT A GLANCE

11:35

13.05

Quick and Clean ADCProcess Development

Translating Scale-DownModels to Scale-Up Success

Analysing ComplexMolecules

14.15 Manufacturing ADCs inMulti-Purpose Facilities

Next GenerationPurification

High ConcentrationFormulations

15.45

16.30 Novel Therapies andNovel Production Methods

Controlling Pluronic inCell Culture

HTPD High ConcentrationFormulations

ADCs, NovelTherapies andBiosimilars

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2 3 4 5Cell Culture,UpstreamProcessing andProcess Analytics

DownstreamProcessing andContinuousManufacturing

Manufacturing,Single-Use and QualityManagement

Analytics,Quality Control andFormulation

Spotlight PresentationsBPI Live Labs followed by Lunch

Spotlight PresentationsAfternoon Tea

08.55 Chairperson’s Opening Remarks, Dr Johannes Roebers, Cilatus BioPharma AG and Elan Pharmaceuticals

09.00Manufacturing plants of the future, Dr Roman Necina, Baxter GmbH

09.30The future of biologics CMC, Dr Jens Vogel, Boehringer Ingelheim

10.00 Continuous manufacturing, process intensification and flexible facilities

10.30 Morning Break

17.30 End of BPI Europe 2015

11.05

12.40

Latest developmentsin PAT and QBD

Continuous Processing Facilities of the Future Process Analytics

14.00 Bringing BiosimilarmAbs to Market

Choosing the BestOnline Analyser

DSP for ComplexProteins

Improving ManufacturingOperations

Choosing The BestOnline Analyser

15.30

16.00 Process DevelopmentFor Biosimilars

From Theory to Lab DSP for ComplexProteins

Risk Mitigation StrategiesFor Single-Use Systems

From Theory to Lab

ADCs, NovelTherapies andBiosimilars

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2 3 4 5Cell Culture,UpstreamProcessing andProcess Analytics

DownstreamProcessing andContinuousManufacturing

Manufacturing,Single-Use and QualityManagement

Analytics,Quality Control andFormulation

Spotlight PresentationsLunch and Partnering Time

Spotlight PresentationsAfternoon Coffee and BPI Poster Award Winner Announced

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DAY TWO PLENARY: Wednesday 15 April 2015

DAY ONE PLENARY: Tuesday 14 April 2015

POST-CONFERENCE WORKSHOPS: Thursday 16 April 2015

PRE-CONFERENCE WORKSHOPS: Monday 13 April 2015Workshop U

Continuous Processing – Strategy, Technologies,Economics & Challenges

Workshop V

Extractables & Leachables: StudyDesign for Disposables System

Workshop W

Practical Quality By Design for Biopharmaceuticals

Workshop X

The Challenge of ProteinAggregation and Sub VisibleParticles in Biopharmaceuticals

Workshop Y

Process Analytical Technology

Workshop Z

Outsourcing, Technology Transferand CMO-Client Relationships

Translating Scale-DownModels to Scale-Up Success

Latest FDA Guideline

Managing ExternalPartners

Managing ExternalPartners / CPV

Biosimilars Market /Setting Standards

Impurities andAggregates

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WORKSHOP UContinuous Processing – Strategy, Technologies, Economics & Challenges

IntroductionThe advantages of continuous manufacturinginclude steady state operation, consistentproduct quality, reduced equipment size,high volumetric productivity, streamlinedprocess flow, low cycle times and reducedcapital cost. This new technology, however,poses challenges of various nature, whichneed to be addressed before large scaleimplementation is considered.

Agenda

Session 1: Strategic Considerationsfor Continuous Processing

Assessing the true value of continuousmanufacturing Facility design and related cost implicationsIntegrating upstream and downstream, Determining the value of changingstrategies and predicting ROITailoring the considerations to fit in withindividual businessesOutlining the conditions that need to be set

Session 2: Implementing ContinuousProcesses and Technology

Application of technologies in upstream/downstream in continuous production:Can they cover the whole process?Are there robust enough technologies at large scale?Impact on process & cleaningdevelopment, validations, versatility Examples of implementation on different scalesPAT is a must!Single use technology to facilitate multi-product systems How to incorporate this technology inestablished facilities Examples of different expression systemsFacilitates Technology Transfer to Thirdcountries

Session 3: Economical EvaluationsEffect on cost of goods, Economical evaluation of single use vs.reusable equipment

Session 4: Day-to-day challengesBatch definition / size / records / releaseSampling strategy and acceptance criteriaFrequent areas for bottlenecking inproduction process

Workshop leaders

Dr Margit Holzer, Scientific Director chez UlysseConsult, France

Dr Roger-Marc Nicoud, Consultant

WORKSHOP VExtractables & Leachables: Study Design for Disposables System

IntroductionSingle-use systems, also referred to asprocessing materials, must be evaluated for their ability to contribute leachables to the final product.Evaluating processing materials forextractables and leachables requires co-operation between vendors and end-users and a commitment to utilise the best science possible within a risk-based framework. End-users may findthemselves customizing a leachables test to meet their specific applicationsbecause other options do not provide a sufficient solution to the requirement. With vendor co-operation and analyticalexpertise, an application-specific leachables evaluation may prove to be straightforward and successful.

AgendaHistory of E&L study designsUnderstand key differences between E&L study designs for disposable andprimary packagingHow to leverage supplier data?Levels of supplier’s data qualityExtractable study design considerationLeachable study design considerationHow to simplify and reduce numbers ofE&L studies?

Workshop leader

Dr Kenneth Wong, MTech/Process Technology -Extractables & Leachables,Sanofi, BPOG Representative, USA

WORKSHOP WPractical Quality By Design for Biopharmaceuticals

IntroductionQuality by Design is positively encouragedby the EMA and FDA and is now becomingincreasingly adopted by biopharmaceuticalcompanies. It has also been coined bysome as ‘Smart Design’.Although indicative regulatory guidelines arein place, they tend to only scratch the surfaceand the devil of course then lies in the detail.In this workshop we will lift Quality by Designoff the page and put it into a tangiblecontext so that the attendees will be able to take way what they have learnt andtranslate this into real and practical action.Using a combination of fundamentalunderstanding, case studies and interactiveteam challenges based on ‘real life’ Qualityby Design scenarios, the workshop willbuild into a useful framework that can beused to underpin putting Quality by Designinto place in the workplace.

AgendaQuality by Design strategiesDissection of component QbD partsAdaptation to different product classesDefining the target product profileProcess and material risk evaluations and controlDerivation and Validation of Design SpacesEstablishing a final Control StrategyIncorporating QbD as part of the qualityand operational systemsMeeting regulatory expectationIncorporation of QbD into dossiersubmissionsApproaches and experience with the EMA and FDA Leveraging Quality and Regulatoryflexibilities

Workshop leader:

Dr Richard Dennett, Director, Voisin Consulting Life Sciences,France

NEWfor 2015

NEWfor 2015

NEWfor 2015

PRE-CONFERENCE WORKSHOPSMONDAY 13 APRIL 2015 Registration at 09.30 • Start 10.00 • End 16.00 • Morning and Lunch Breaks are Included

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WORKSHOP XThe Challenge of Protein Aggregation and Sub Visible Particles in Biopharmaceuticals

IntroductionThe workshop will address the mechanismof aggregation and the implications onproduct development. New analyticalmethods will be presented and discussedand strategies to avoid and reduceaggregation in biopharmaceuticals willalso be highlighted. Attendees will gain a critical overview of the complexity and diversity of the aggregation and sub-visible particles of peptide andprotein biopharmaceuticals and onstrategies to overcome these issues.

AgendaDifferent aggregation mechanisms willfocus on peptide and protein examplesAvailable techniques for detection ofaggregation and impurities (leachables)and how these methods can be applied.Combining analytical methods to ensuredetection of aggregates across a range of particle sizes. New technologies forcharacterisation of aggregates will be presented.Strategies for developing stable peptidedrug formulations. High-throughputanalysis (HTA) and high-throughputformulation (HTF) platforms will bepresented. Using case studies, potentialcauses of aggregation and preventionstrategies will be discussed.Aggregation of biopharmaceuticals inhuman plasma depends on formulation: a new development and research fieldRegulatory aspects and concerns

Workshop leaders

Professor Tudor Arvinte, Chairman, School of PharmacyGeneva-Lausanne, Switzerland and Chairman, CEO,Therapeomic Inc. Switzerland

WORKSHOP YProcess Analytical Technology

IntroductionPart One: This part of the course will providean overview of closed loop process controlfor scientists with limited background inprocess control and automation. Sufficientknowledge will be provided to allow delegatesto appreciate the scope of process controltechnologies and the challenges that needto be considered when implementing processcontrol strategies within a PAT and QbDenvironment. The topics will include: classicalfeedback control with process examples;feed-forward and inferential control; multi-loop control; analytical (PAT) feedbackcontrol; and will finish with a brief overviewof more advanced control systems now beingapplied. Industrial case studies will be used.

AgendaLearn about the concepts of closed loopprocess control and its importanceBe able to have informative process controlstrategy discussions with your processcontrol and engineering colleaguesBe aware of the potential for closed loopprocess control in product and processdevelopment phases

Part Two: Data pre-screening and building robust models, calibrations and calibration transferThis part of the workshop will provide an overview of highly visual process and spectral data pre-screening and pre-processing prior to the building of processperformance monitoring (multivariatestatistical process control) models or PATcalibrations. Case studies will highlight anumber of important issues that need to be considered during the delivery processand spectroscopic data for subsequentanalysis and modelling.

Take home messagesLearn about how data collection and datapre-screening/pre-processing can impactthe information and know-how derivedfor complex processesBe able to be involved in developing theprocess performance monitoring andmultivariate statistical process controlstrategies with your engineering colleaguesBe aware of the potential for poor PATcalibrations and calibration transfer fromlab to manufacturing

Workshop leader

Professor Julian Morris, TechnicalDirector Centre for Process Analyticsand Control Technology, CPACT,University of Strathclyde, UK

WORKSHOP ZOutsourcing, TechnologyTransfer and CMO-ClientRelationships

IntroductionThis workshop will discuss the lessonslearned from a broad range ofbiopharmaceutical projects developedsuccessfully by the workshop instructors,who represent both the Client and the CMO sides.

AgendaThe focus of the workshop will be on the key elements to develop apartnership between the parties, covering all phases, from the CMOselection activity, technology transfer of processes and test methods, toproduction, testing, and delivery ofClinical Trial Materials (CTM).Additionally, the workshop will include an interactive case study, offering theparticipants hands-on experience withdifferent CMO selection, risk assessmentand mitigation, as well as vendormanagement tools developed to facilitate cost effective and successfultransfer and development ofbiopharmaceuticals in partnershipbetween the Client and the CMO.

Workshop leaders

Dr. Firelli Alonso-Caplen, Senior Director, External Supply,Pfizer, Inc., USA

Mr. Morten Munk, Vice President,Business Development, CMC Biologics A/S, Denmark

5 New Workshops on:

Continuous Processing Extractables & Leachables QbD and Risk Management The Challenge of Protein Aggregation Outsourcing, Technology Transfer and CMO-Client Relationships

UPDATEDfor 2015

NEWfor 2015

NEWfor 2015

POST-CONFERENCE WORKSHOPSTHURSDAY 16 APRIL 2014 Registration at 08.30 • Start 09.00 • End 15.00 • Morning and Lunch Breaks are Included

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Managing product quality across anincreasingly global manufacturingnetworkProduct quality is increasingly importantwhen manufacturing biologics for patients,regulators and industry as a whole. Thispresentation will look at challenges inestablishing a successful Quality ManagementSystem, preventative strategies andcorrective solutions and how industry can come together to ensure quality.

Dr Anthony Mire-Sluis, Vice President, North America,Singapore, Contract and Product Quality, Amgen, USA

Driving inefficiencies out ofbioprocessingBiopharmaceutical production facilitiestoday must be flexible and simple tooperate to meet the demands ofpersonalized medicine and emerging global biosimilars and vaccines markets. We will discuss advancements in media and cell line engineering in combinationwith innovative affinity purification systems,process analytics platforms and single usesystems to drive productivity gains.

Craig E. Smith, Ph.D, Vice President Bioproduction Division, Life Science Solutions Group,Thermo Fisher Scientific, USA

Experiences and strategies to supportprojects with FDA breakthroughdesignation for biologicsWith the breakthrough designation FDA has created a powerful tool to acceleratedevelopment and approval of drugs, which provide a substantial improvementover available therapies to treat a seriouscondition. The acceleration leads to someimportant consequences for the CMC workpackages and submission. This presentationwill report some recent experiences andstrategies to prepare for the submission.

Dr Niklas Engler, Head, TechnicalDevelopment, Biologics Europe,Roche, Switzerland

The FDA breakthroughdesignation has created apowerful tool to acceleratedrug development.However this leads to someimportant consequencesfor the CMC work packagesand submission.Niklas Engler, Roche

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An extremely relevant conference,worth every minute spent here2014 Attendee, Novartis, Switzerland

‘‘ ‘‘CURRENT CHALLENGES AND NEW OPPORTUNITIESCONFERENCE DAY ONE: TUESDAY 14TH APRIL 2015

Seven EXCLUSIVE PLENARYPRESENTATIONS

Prof Wolfram Carius, SVP, Sanofi, Plenary 2014

Challenges and opportunities invaccine manufacturingThis presentation will discuss the specificchallenges facing vaccine manufacturing:high quality, very high volumes, increasingregulations, flexible and complex supplychain, low COGS, and high reliability. Theseconstraints make vaccine manufacturing anunusually challenging production problemin the entire manufacturing sector across allindustries. The talk will take a de-novo viewof the problem and ask how to address thisproblem in the context of availableproduction technologies. The talk willchallenge conventional thinking andattempt to set up manufacturing solutionsfor the next 15-20 years.

Dr Rahul Singhvi, Chief Operating Officer, Takeda Vaccines, USA

Future of biomedicinesFrom recombinant insulin in 1982 to stemcell therapy for diabetes type 1 in the nextdecade: the biopharma industry is lookingat permanent advancement in science and subsequently new therapeutic modesand molecules with the correspondingprocessing challenges. This crystal ball view will exemplify the potential changes inwhat we may deal with and how we mightoperate 10-20 years from now.

Dr Günter Jagschies, Senior DirectorStrategic Customer Relations,GE Healthcare Life Sciences, Sweden

The future of biomanufacturingFuture plants need to have a high degree of flexibility to compensate for the clinicaldevelopment risk, to meet various productspecific process requirements and to enablefast tracking of clinical development fornew compounds. Today’s manufacturingprocesses need to be re-designed andstandardised to fit into the plants of the future.

Dr Roman Necina, Vice President Process Science & Technical Operations, BaxterInnovations GmbH, Germany

The future of CMCWith mAbs dominating today’s biologicspipelines, development and manufacturingis focused on leveraging a “consensus”platform. However, the staggering overallR&D costs and strong pressures to reduceoverall healthcare cost are driving newmodels, such as, biosimilars, biobetters andpersonalised medicines. As a result, flexibleand innovative CMC strategies are needed.New approaches, such as continuousbiomanufacturing, will be highlighted.

Dr Jens H. Vogel, Global Head, CMC Strategy & TRA,Boehringer IngelheimBiopharmaceuticals, Germany

DISCUSSION PANELStrategies to Implement ContinuousProcessing in Biotech

Companies' experiences of implementingcontinuous processingMaximising facility functionality? What are the drivers and advantages of using continuous processing?Semi-continuous vs. fully continuous Regulatory hurdles?Defining a batchVendor support for continuous processing?What will it mean for employees?

Chairperson:Dr Johannes Roebers, President,Cilatus BioPharma AG, former EVP and Head of Operations at

Elan Pharmaceuticals, Switzerland

Dr Jens H. Vogel, CMC Strategy and TechnicalRegulatory Affairs Biopharm,Boehringer Ingelheim, USA

Dr Roman Necina, Vice President Process Science & Technical Operations, Baxter GmbH, Austria

Dr Klaus Graumann, Global Technical Development Operations,Sandoz BP, Austria

Today's manufacturing processes needto be re-designed and standardised tofit into the plants of the futureRoman Necina, VP, Baxter

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THE FUTURE OF BIOTECH AND PATIENT NEEDSCONFERENCE DAY ONE: TUESDAY 14TH APRIL 2015

CONTINUOUS MANUFACTURING, PROCESSINTENSIFICATION AND FLEXIBLE FACILITIESCONFERENCE DAY TWO: WEDNESDAY 15TH APRIL 2015

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Welcome Drinks, Canapes and Wine Casino

This reception will provide a fun environment for socialising with friends and colleagues. Hosted by wine experts there will be authentic casino tables and entertaining games. This is a great opportunity to meet the speakers from the conference and kick off your experience of BPI 2015!

WELCOME DRINKS


08.20 Chairperson’s Opening Remarks

IMPROVING PRODUCT QUALITY08.30 Managing product quality across an increasingly global manufacturing network

Dr Anthony Mire-Sluis, Vice President, North America, Singapore, Contract and Product Quality,Amgen, USA

DRIVING OUT INEFFICIENCIES09.10 Innovation that drives process efficiency

Craig E. Smith, Ph.D, VP, Bioproduction Division, Life Science Solutions Group,Thermo Fisher Scientific, USA

SUPPORTING FDA BREAKTHROUGH DESIGNATION09.50 Experiences and strategies to support projects with FDA breakthrough designation

for biologicsDr Niklas Engler, Head, Technical Development, Biologics Europe, Roche, Switzerland

10.30 Morning Coffee and Start of


QUICK AND CLEAN ADC PROCESS DEVELOPMENT11.35 From bench to GMP, develop quick and clean ADC processes

Dr Eric Lacoste, ADC Team Leader, sanofi-aventis R&D, France

12.05 Optimising process development for antibody-drug-conjugates: Dissolved Oxygen Fluctuation Induces Lactate Production in a Fed-Batch CHO Cell ProcessDr Michael Hippach, Group Lead, Cell Culture, Agensys, USA

12.35 New opportunities in bioprocessingRepresentative, GE Healthcare

13.05 BPI Live Labs and Lunch

MANUFACTURING ADCS IN MULTI-PURPOSE FACILITIES14.15 Clinical manufacturing of antibody drug conjugates in multi-purpose facilities

Dr Felix Oehme, Head of Biologics Pilot Plant Global Biologics Development, Bayer Pharma AG, Germany

14.45 DISCUSSION PANEL Key considerations when manufacturing ADCsDr Eric Lacoste, ADC Team Leader, sanofi-aventis R&D, FranceDr Felix Oehme, Head of Biologics Pilot Plant Global Biologics Development, Bayer Pharma AG, Germany

15.15 Protein A capture step cost reductions driven by the use of pre-packed columnsDr Fletcher Malcom, Associate Director, Repligen, USA

15.45 Afternoon Break

NOVEL THERAPIES AND NOVEL PRODUCTION METHODS16.30 BEAT bispecific antibody: from platform process development to GMP manufacturing

Dr Roberto Giovannini, Head of Process Development, Glenmark Pharmaceuticals SA, Switzerland

17.00 Exploitation of the Tat protein export pathway for the production of high-quality biopharmaceuticals in E. coliProfessor Colin Robinson, School of Biosciences, University of Kent, UK

17.15 Heterologous protein secretion by Bacillus subtilis: From the cradle to the graveProfessor Colin Harwood, University of Newcastle, UK

17.30 Change Over

PREPARING FOR FUTURE PATIENT NEEDS17.35 Challenges and opportunities in vaccine manufacturing


18.05 Future of biomedicinesDr Günter Jagschies, Strategic Customer Relations Lead, GE Healthcare, Sweden


18.40 Networking Drinks and Canapes followed by Wine Casino (see page 7 for more information)

1. ADCS, NOVEL THERAPIES AND BIOSIMILARS

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CONFERENCE DAY ONE: TUESDAY 14 APRIL 2015

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We can perform clinical manufacturing of ADCs in multi-purpose facilitieswhere antibodies as well as ADCs can be produced in the same cleanroom.

Felix Oehme, Bayer, speaking at 14.30, Day One

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CONFERENCE DAY TWO: WEDNESDAY 15 APRIL 2015

TABLE 1 TABLE 2

CONTINUOUS MANUFACTURING, PROCESS INTENSIFICATION AND FLEXIBLE FACILITIES08.55 Chairperson’s Opening Remarks

Dr Johannes Roebers, President, Cilatus BioPharma AG, former EVP and Head of Operations atElan Pharmaceuticals, Switzerland

09.00 Manufacturing plants of the futureDr Roman Necina, Vice President Process Science & Technical Operations, Baxter GmbH, Austria

09.30 The future of biologics CMCDr Jens Vogel, Global Head, CMC Strategy and Technical Regulatory Affairs Biopharm,Boehringer Ingelheim,

10.00 Continuous manufacturing, process intensification and flexible facilitiesDr Roman Necina, Vice President Process Science & Technical Operations,Baxter GmbH, AustriaDr Jens Vogel, Global Head, CMC Strategy and Technical Regulatory Affairs Biopharm, Boehringer Ingelheim, USADr Klaus Graumann, Global, Technical Development Operations, Sandoz, Austria

10.30 Morning Break

ANALYSING THE BIOSIMILARS MARKET AND SETTING REFERENCE STANDARDS

11.05 Chairperson's Opening Remarks

11.10 An analysis of the global biosimilars marketDr Giles Somers, Lead Analyst, Datamonitor, UK

11.40 The role of pharmacopeial standards in the context of biosimilarsDr Tina S. Morris, VP, Biologics & Biotechnology United States Pharmacopeial Convention, USA

12.10 Spotlight PresentationThis slot is reserved for technology and service providers, please contact [email protected] for more info.

12.40 Lunch and Partnering Time

12.50 BPI Knowledge Exchange

Process Development Quality by Design - for Novel Therapies Shared Experiences

BRINGING BIOSIMILAR MABS TO MARKET14.00 CMC challenges in development of Remsima

Dr Elizabeth Pollitt, VP, Head of CMC Regulatory Affairs, Celltrion, South Korea

14.30 Six blind men and a beast: Co-operative analytics holds the key for product driven process developmentDr Himanshu Gadgil, Senior Vice President, Intas, India


15.30 Afternoon Coffee and BPI Poster Award Winner Announced

PROCESS DEVELOPMENT FOR BIOSIMILARS16.00 Approaches to optimise production bioreactor conditions for biosimilar products

Dr Philip Mellors, Head, Upstream Development, Actavis, UK

16.30 From the world's first epoetin alfa biosimilar to third wave biosimilars: key success factors for 21st century biosimilar companiesDr Carsten Brockmeyer, CEO, Formycon, Germany

17.00 End of Day Two

To read the full abstract, please visit www.bpi-eu.com

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2. CELL CULTURE, UPSTREAM PROCESSINGAND PROCESS ANALYTICS











TRANSLATING SCALE-DOWN MODELS TO SCALE-UP SUCCESS11.35 The role of high-throughput mini-bioreactors in process development and process optimisation

Dr Yao-Ming Huang, Principal Engineer, Cell Culture Engineering, Biogen Idec, USA

12.05 Exploring the AMBR system as a scale-down model for perfusion microcarrier based cell culture processesDr Marijke Wynants, Process Engineer, Cell Culture, MAST, Genzyme, Belgium

12.35 Complex or defined? – Having choices matters for mammalian cell culture feeding and supplementationDr Elizabeth C. Dodson, Research and Development Manager, BD Biosciences - Advanced Bioprocessing, USA


TRANSLATING SCALE-DOWN MODELS TO SCALE-UP SUCCESS14.15 Scale up or scale down?

Dr Ciska Dalm, Lead Scientist, Upstream Process Development, Synthon, The Netherlands

14.45 Overcoming challenges in development and scale-up of a fusion protein cell culture processDr Anli Ouyang, Group Leader, Cell Culture, Eli Lilly and Company, USA

15.15 Implementing a risk-management based approach for preventing mycoplasma contaminationAndrew Kelly, Product Manager, Life Sciences, Parker Hannifin, UK


CONTROLLING PLURONIC IN CELL CULTURE16.30 Understand and control Poloxamer 188 in cell culture processes

Dr Weiwei Hu, Senior Engineer III, Cell Culture Development, Biogen Idec, USA

17.00 Discussion Panel: Special focus on Poloxamer 188 (Pluronic) in cell cultureSummary of recent reports Limitations of available tests to detect pluronicWhat are the alternatives? Can it be replaced to ensure higher grade

Representative, Thermo Scientific

17.30 Change Over



18.05 Future of BiomedicinesDr Günter Jagschies, Strategic Customer Relations Lead, GE Healthcare, Sweden




Showcase, Educate, Connect

Tuesday 14 - Wednesday 15 April 2015 • Swissôtel Düsseldorf Neuss, Germany


11TH ANNUAL

www.bpi-eu.com

EXHIBITION SUPPLEMENT

Associate Sponsors

For further information about Exhibition & Sponsorship opportunitiesplease contact: [email protected], tel: +44 (0)207 017 5011

Corporate Sponsors

Our attendees have told us that BioProcess InternationalEuropean Summit is the must attend event because its...

the perfect place fornetworking with Europeanleaders in bioproductionRCPE GmbH

a great brand, good programand has PartneringONECMC Biologics

an ultimately relevant conferenceworth every minute spent hereNovartis

a high level professional eventwhere the business contacts are goodSGS


Industry partners alreadyin attendance

Primary Audience breakdown

400+ATTENDEES

179COMPANIES

2015

19%NEW COMPANIES

ACCELERATE YOUR BUSINESS AT THE BPI CONFERENCEAND EXHIBITION. VITAL STATISTICS FROM 2014:

Scientist /Researcher

49%

C-Level/VP

14%

Academics8%

Lab Manager /Department Head

29%

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One of the many benefits is your access to our extensive database ofbio pharmaceutical executives.

Our marketing reach

For further details on sponsoring and exhibiting at BPIEurope, please contact: [email protected];

tel: +44 (0) 207 017 5011

1400+followers

10,000+groupmembers

Through you can

Pre-Arrange peer to peermeetings at the event

Preview a listof attendees

weeks inadvance

Engage in pre-event

discussions

USA

16% SouthernEurope

5%

NorthernEurope

9%

ROW

2%

MiddleEast2%

10,000+

biopharm contacts

2014 Partnering Statistics:

• 182 x pre arranged meetings took place

• Average networking rating:4.1 out of 5

Ave. Unique pageviews per month:

3702WesternEurope

66%

Live Labs - Back by Popular Demand! Do you have a new or unique product you wish to demo?

To take part in the live labs tour and direct traffic to your booth please contact [email protected] for more information

14


Corporate Sponsors

Sponsors

Exhibitors

For further details onsponsoring and exhibiting atBPI Europe, please contact:[email protected];

tel: +44 (0) 207 017 5011

Associate Sponsor


Industry is increasingly seeking means by which critical processparameters can be monitored and controlled in real-time

Sophie Goetschalckx, Genzyme, speaking at 14.00, Day Two

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10.30 Morning Break


LATEST DEVELOPMENTS IN PAT AND QBD

11.10 Improving the efficiency, controllability and robustness of pharmaceutical manufacturing through smart PATProfessor Julian Morris, Technical Director Centre for Process Analytics and Control Technology, CPACT, University of Strathclyde, UK

11.40 KEYNOTEQbD-complied quasi-continuous production strategies for pharmaceutical proteins - from PAT to MVDA controlled processesProfessor Reiner Luttmann, Research Center of Bioprocess Engineering and Analytical Techniques, Hamburg University of Applied Sciences, Germany



12.50 BPI Knowledge Exchange (see page 9 for more details)

CHOOSING THE BEST ONLINE ANALYSER14.00 In Situ Raman Spectroscopy for bioreactor characterisation by simultaneous real-time

monitoring of multi process parametersDr Sofie Goetschalckx, Manufacturing Cell Culture Science Lead – Technology Department, Genzyme, Belgium

14.30 Process analytics showing several innovative approaches to speed up analytics during process developmentDr Christian Hunzinger, Molecular Lead, Biotech Product Development,Merck Serono, Switzerland


15.30 Afternoon Tea

16.00 Bioprocess analytical development: An attribute led toolboxJeremey Springall, Scientist I, Development, MedImmune

FROM THEORY TO LAB16.30 IN THE LAB SCENARIO

Practical considerations when applying PAT to bioprocessingMoving a probe from R&D to the development to manufacturingDesigning what you’ve got to model Integrating software analysis for PATHow to validate probes and software Working with in-process testing team

PanelistsProfessor Julian Morris, University of StrathclydeDr Sofie Goetschalckx, Manufacturing Cell Culture Science Lead – Technology Department, Genzyme, BelgiumDr Yao-ming Huang, Principal, Biopharm Development Engineer, Biogen Idec, USA

17.00 Chairperson’s Closing Remarks


3. DOWNSTREAM PROCESSING ANDCONTINUOUS MANUFACTURING











REMOVAL OF PROCESS RELATED IMPURITIES AND AGGREGATES DURING HARVEST PRE-TREATMENT

11.35 Development of new clarification platform that enables two-stage chromatography purification of recombinant therapeutic antibodies Dr Nripen Singh, Senior Engineer, Biologics Development, Bristol Myers Squibb, USA

DEVELOPMENT AND IMPLEMENTATION OF NEXT GENERATION PURIFICATION TECHNOLOGIES

12.05 High pressure refolding as an alternative technology in protein manufacturingDr Linda Gombos, Postdoc, Boehringer Ingelheim RCV, Austria

12.35 In-line concentrator for product concentration for mAbs and other therapeutic proteinsMr Ole Elvang Jensen, Research Scientist, Protein Separation & Virology Department,Novo Nordisk A/S, Denmark

13.05 BPI Live Labs followed by lunch

14.15 Novel techniques for improved separationDr Chen Wang, Sr. Group Leader, Process Sciences, Purification, AbbVie Bioresearch Center, USA

14:45 Production and purification of Duobody® Bispecific antibodies Dr Rick Hibbert, Protein Separation Scientist, Genmab, The Netherlands

15.15 The benefits of high performing chromatography resins including POROS® XQ, a new strong anion exchangerDr Stuart Melville, Senior Field Applications Specialist, Thermo Fisher Scientific

15:45 Afternoon Break

ACCELERATION OF PURIFICATION PROCESS DEVELOPMENT ANDCHARACTERISATION USING HIGH THROUGHPUT A UTOMATION

16.30 Challenges & opportunities of protein-based vaccine process development & manufacturingDr Yan-ping Yang, Head of Bioprocess Research & Development North America, Sanofi Pasteur, Canada

17.00 Acceleration of purification process development and characterisation using high throughput automationSibylle (Billie) Herzer, Principal Scientist, Biologics Development, Recovery & Purification,BMS, USA

17.30 Change Over

PREPARING FOR FUTURE PATIENT NEEDS

17.35 Challenges and opportunities in vaccine manufacturingDr Rahul Singhvi, Chief Operating Officer, Takeda Vaccines, USA





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Advances in cell culture have increased product titres, cell density andcellular debris; improvements in DSP are therefore essential

Nripen Singh, BMSSpeaking at 11:35, Day One

‘‘ ‘‘







10.30 Morning Break

IMPLEMENTATION OF CONTINUOUS DOWNSTREAM PROCESSING


11.10 Implementation of downstream continuous processingProf. Alois Jungbauer, Professor, Austrian Centre of Industrial Biotechnology (acib), Austria

11.40 Integrated continuous manufacturing of therapeutic proteinsProf. Massimo Morbidelli, Department of Chemistry & Applied Biosciences, ETH Zurich, Switzerland

12.10 A development platform for monoclonal antibodies including continuous chromatographyDr Francis Dupont, Technology Deputy Director, Novasep Belgium



14.00 Chromatography case study: Implementation of continuous downstream processingProfessor Manuel J T Carrondo, Professor of Chemical and Biochemical Engineering, Director,IBET, Portugal

INNOVATIVE PURIFICATION TECHNIQUES FOR MORE COMPLEX PROTEINS

14.30 Considerations for rapid development of non mab purification processesDr Richard Turner, Associate Director, Biopharmaceutical Development, MedImmune Ltd, UK


15.30 Afternoon Tea

16.00 Development of a complex purification process for a novel format antibodyDr Eva Rosenberg, Manager Recovery & Downstream Processing, Roche Diagnostics, Germany

16.30 Strategies and process modifications to overcome purification challenges for complex proteinsDr Bas Kokke, Principal Scientist, DSP, Synthon, The Netherlands



4. MANUFACTURING, SINGLE-USE ANDQUALITY MANAGEMENTCONFERENCE DAY ONE: TUESDAY 14 APRIL 201507.30 Registration and Morning Coffee










INTERPRETING LATEST FDA GUIDELINE ON CONTRACT MANUFACTURING11.35 Biopharmaceutical CMO market overview

William Downey, President, HighTech Business Decisions, USA

12.05 Implementing Quality Agreements in your operations and assuring it meets the new FDA expectationsDr Peter H. Calcott, President, Calcott Consulting, USA

12.35 Advancing scale-up manufacturing through innovative technologies in cell culture media and SU technologiesDr Shawn Barrett, Associate Director, R&D Cell Biology, BioProduction,Thermo Fisher Scientific, USA


SUCCESSFUL PROJECT MANAGEMENT OF OUTSOURCED PARTNERS14.15 Choosing, selecting and managing your external partners

Dr. Firelli Alonso-Caplen, Senior Director, BioTherapeutics & Vaccines Outsourcing, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

14.45 Selecting and managing your external partners for biomanufacturingDr Ulrich Ruemenapp, Head, Biotech Projects, Contract Manufacturing Biotech, Bayer, Germany



WIN-WIN RELATIONSHIP WITH YOUR CMO16.30 Key factors for selection and establishment of win-win relationship with your CMO

Dr Yong Jick Kim, Biotechnology & Operations Consultant, (Former President, MFG & Technical Operations at Celltrion Inc

UPDATE ON CONTINUED PROCESS VERIFICATION WORKSTREAM 17.00 CPV in biopharm manufacturing – an implementation update

Graham McCartney, Technical Lead Biotechnology, Eli Lilly and Company, Ireland

17.30 Change Over






19


I will outline the challenges, best practices and how to avoid pitfalls whenoutsourcing the manufacture of biopharmaceuticals

Ulrich Ruemenapp, BayerSpeaking at 11:35, Day One

‘‘ ‘‘






10.30 Morning Break

11.00 Capacity, technology and innovation trends in a high variety product portfolio worldSimon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom


FACILITIES OF THE FUTURE11.40 Sustainable biomanufacturing

Dr Alain Pralong, VP New Product Introduction and Technical Life Cycle Management,GSK, Belgium

12.10 Biopharmaceutical factory of the futureDr Richard Alldread, Head of Innovation, CPI, UK



IMPROVING MANUFACTURING OPERATIONS14.00 How organisational and cultural behaviour can improve biomanufacturing

Dr Kim Sandell, Director, Supply and Operational Excellence, Pfizer, Sweden

14.30 Design and implementation of a new tailored single use GMP facility for early clinical phase Mab/bispecific productionDr Pascal Torregrossa, Head of GMP manufacturing, Glenmark, Switzerland


15.30 Afternoon Tea

RISK MITIGATION STRATEGIES FOR SINGLE-USE SYSTEMS16.00 BPOG

Standardisation and testing strategies for Single-Use SystemsDr Kenneth Wong, BPOG Representative, Sanofi, USA

16.15 BPSAStandardisation and testing strategies for Single-Use SystemsDr Jerold Martin, Senior VP, Global Scientific Affairs. Pall Life Sciences, USA, Chair, BPSA

16.30 SUTAPStandardisation and testing strategies for Single-Use SystemsDr Alain Pralong, VP New Product Introduction and Technical Life Cycle Management,GSK, Belgium, Member of SUTAP (Single-Use Technology Assessment Project)

16.45 Discussion Panel



20

5. ANALYTICS, QUALITY CONTROLAND FORMULATIONCONFERENCE DAY ONE: TUESDAY 14 APRIL 201507.30 Registration and Morning Coffee










ANALYSING COMPLEX MOLECULES11.35 Emerging mass spectroscopy “toolbox” for antibodies, biosimilars,

bispecifics and antibody drug conjugatesDr Alain Beck, Centre d’Immunologie, Pierre Fabre; Associate Editors,mAbs

12.05 Identification and monitoring of CQAs for novel molecules to support tailored bioprocess developmentDr Emmanuel Rossy, Scientist II, Analytical Biotechnology (Sciences & Strategy),MedImmune, UK

12.35 QbDJesse McCool, SVP of R&D services, Cytovance, USA


HIGH CONCENTRATION FORMULATIONS14.15 Mechanisms of protein association and their impact on solubility and viscosity

Professor Thomas Laue, Director, Biomolecular Interaction Technologies Center (BITC),University of New Hampshire, USA

14.45 Instability of high concentration monoclonal antibody formulations: a comparison of the IgG1 and IgG4 subclassDr Marco van de Weert, Associate Professor, Department of Pharmacy, Section for Biologics,University of Copenhagen, Denmark



16.30 Assessment of chemical modifications of sites in the CDRs of recombinant antibodies: Susceptibility vs. functionality of critical quality attributesDr Markus Haberger, Group Leader, Characterisation, Roche Diagnostics, Germany

17.00 Simultaneous characterisation and affinity determination of biopharmaceuticalsProf Gerhardus de Jong, Biomolecular Analysis, Utrecht University, The Netherlands

17.30 Change Over






21


Industry is increasingly seeking means by which critical processparameters can be monitored and controlled in real-time

Sophie Goetschalckx, Genzyme, speaking at 14.00, Day Two

‘‘ ‘‘






10.30 Morning Break


PROCESS ANALYTICS

11.10 Improving the efficiency, controllability and robustness of pharmaceutical manufacturing through smart PATProfessor Julian Morris, Technical Director Centre for Process Analytics and Control Technology, CPACT, University of Strathclyde, UK

11.40 KEYNOTEQbD-complied quasi-continuous production strategies for pharmaceutical proteins - from PAT to MVDA controlled processesProfessor Reiner Luttmann, Research Center of Bioprocess Engineering and Analytical Techniques, Hamburg University of Applied Sciences, Germany




CHOOSING THE BEST ONLINE ANALYSER14.00 In Situ Raman Spectroscopy for bioreactor characterisation by simultaneous real-time

monitoring of multi process parametersDr Sofie Goetschalckx, Manufacturing Cell Culture Science Lead – Technology Department, Genzyme, Belgium

14.30 Process analytics showing several innovative approaches to speed up analytics during process developmentDr Christian Hunzinger, Molecular Lead, Biotech Product Development,Merck Serono, Switzerland


15.30 Afternoon Tea

16.00 Bioprocess Analytical Development: An Attribute Led ToolboxJeremey Springall, Scientist I, Development, MedImmune

FROM THEORY TO LAB16.30 IN THE LAB SCENARIO

Practical considerations when applying PAT to bioprocessingMoving a probe from R&D to the development to manufacturingDesigning what you’ve got to model Integrating software analysis for PATHow to validate probes and software Working with in-process testing team

PanelistsProfessor Julian Morris, University of StrathclydeDr Sofie Goetschalckx, Manufacturing Cell Culture Science Lead – Technology Department, Genzyme, BelgiumDr Yao-ming Huang, Principal, Biopharm Development Engineer, Biogen Idec, USA



22


Sponsored and judged by

Why not consider presenting a poster at this conferenceto derive more value from attending. Share your researchwith your peers and learn from other posters as well.Many attendees tell us that being selected for a posterpresentation helps to facilitate their company approveprocess to attend the conference.

All poster abstracts received by March 27, 2015 andpresented at the 2015 BioProcess International™Conference and Exhibition are automatically eligible for the Poster Award competition sponsored byBioProcess International magazine.

Posters will be reviewed and judged by BioProcess International’s Editor-in- Chief and Scientific Advisory Board.

To submit your poster and for additional details on deadlines and the poster size and regulations, please visit: www.bpi-eu.com

Poster, Partnering and Networking Opportunities @BPI

Founding Publication Media Partners

Connect Before, During and After the Meeting

Present a Poster - €100 prize for top two plus exposure on BPI Poster Hall

Before

Building on the success at last years’ event we will be using the partneringONE® networking tool at BioProcess Internationalas used at BIO-Europe®.

partneringONE® is an industry recognised partnering system that allows you to:

• Arrange one-to-one meetings at the event

• Engage in pre-event discussions

• See a list of attendees.

All meetings will be pre-arranged for you based on youravailability, so you maximize your time at BioProcess International.

All registered attendees are sent an email with a link to theBioProcess International partneringONE® site, along with their username & password. Please visit our event websitewww.bpi-eu.com for further details.

In its first year at BioProcess International, 420 of our attendeeswere registered on partneringONE® and over 180 scheduledmeetings took place.

During1.Organise 1-2-1 meetings with key industry and academics contactsusing our brand new partnering systems, partneringONE

2. BPI Live Labs - New interactive tours providing a practical insightinto the new technologies and workflows improving bioprocessing

3. Off the Record Breakouts - Small-grouped discussion panels onNovel Formats, Chinese biotech and Extractables and Leachables

4. Poster Sessions - Dedicated poster session showcasing the latestinnovations and science shaping the future of bioprocessing

Welcome Drinks, Canapes and Wine CasinoThis reception will provide a fun environment for socialising with friends and colleagues.

Hosted by wine experts there will be authentic casino tables and entertaining games.

This is a great opportunity to meet the speakers from theconference and kick off your experience of BPI 2015!

Keep up-to-date with the latest industry developmentsand network with colleagues facing the same challengesas you by joining the BioProcessing Professionals EuropeLinkedIn Group. You can also use this platform to keep intouch with contacts made during the conference.

Follow us on Twitter

Follow @bpieurope on Twitterfor updates, special articlesand news announcementsabout the event.

For access to exclusive interviews, conference reviews and product launches, make sure you take a look at ourBioProcessEurope YouTube Channel

www.youtube.com/user/BioprocessEurope

After

23


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Key Themes of 2015:

New Sessions: FDA Breakthrough Strategy, Quality ManagementAgreements, CMO Management, Continuous Processing, In-ProcessTesting and Online Analytics, CPV, PD for Novel Proteins, HarvestPre-treatment

New Formats: BPI Live Labs; BPI Knowledge Centres on PlatformDevelopment for Novel Therapies and QbD; "In the Lab" Walkthroughfor Practical Learnings

New Pricing: £999 Flash Price, £499 for Academics and SubsidisedRates for SMEs

Where industry connects to share new ideas and innovations across allphases of bioprocess development

400+ Attendees

90+ Industry Speakers - More senior-level speakers than in any previous year

10+ Hours of Partnering and Networking – including PartneringONE™

85+ Sponsors and Exhibitors – meet all the key CMOs, CROs, equipmentproviders and media suppliers in one place


inform, innovate and connect flash £999...inform, innovate and connect april 2015 14-15 this...

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