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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E U R O P E A N S U M M I T
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
07.30 Registration and Morning Coffee
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
11.30 Chairperson’s Opening Remarks
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
Dr Rahul Singhvi, Chief Operating Officer, Takeda Vaccines, USA
18.05 Future of biomedicinesDr Günter Jagschies, Strategic Customer Relations Lead, GE Healthcare, Sweden
18.35 Closing Remarks
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
15.00 Spotlight PresentationThis slot is reserved for technology and service providers, please contact [email protected] for more info.
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
07.30 Registration and Morning Coffee
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
11.30 Chairperson’s Opening Remarks
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
13.05 BPI Live Labs and Lunch
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
15.45 Afternoon Break
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
PREPARING FOR FUTURE PATIENT NEEDS17.35 Challenges and opportunities in vaccine manufacturing
Dr Rahul Singhvi, Chief Operating Officer, Takeda Vaccines, USA
18.05 Future of BiomedicinesDr Günter Jagschies, Strategic Customer Relations Lead, GE Healthcare, Sweden
18.35 Closing Remarks
18.40 Networking Drinks and Canapes followed by Wine Casino (see page 7 for more information)
CONFERENCE DAY ONE: TUESDAY 14 APRIL 2015
Showcase, Educate, 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
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
E U R O P E A N S U M M I T
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%
12
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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
E U R O P E A N S U M M I T
Corporate Sponsors
Sponsors
Exhibitors
For further details onsponsoring and exhibiting atBPI Europe, please contact:[email protected];
tel: +44 (0) 207 017 5011
Associate Sponsor
CONFERENCE DAY TWO: WEDNESDAY 15 APRIL 2015
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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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
11.05 Chairperson's Opening Remarks
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
12.10 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 (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
15.00 Spotlight PresentationThis slot is reserved for technology and service providers, please contact [email protected] for more info.
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
To read the full abstract, please visit www.bpi-eu.com
3. DOWNSTREAM PROCESSING ANDCONTINUOUS MANUFACTURING
07.30 Registration and Morning Coffee
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
11.30 Chairperson’s Opening Remarks
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
18.05 Future of BiomedicinesDr Günter Jagschies, Strategic Customer Relations Lead, GE Healthcare, Sweden
18.35 Closing Remarks
18.40 Networking Drinks and Canapes followed by Wine Casino (see page 7 for more information)
CONFERENCE DAY ONE: TUESDAY 14 APRIL 2015
17
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
‘‘ ‘‘
CONFERENCE DAY TWO: WEDNESDAY 15 APRIL 2015
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
IMPLEMENTATION OF CONTINUOUS DOWNSTREAM PROCESSING
11.05 Chairperson's Opening Remarks
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
12.40 Lunch and Partnering Time
12.50 BPI Knowledge Exchange (see page 9 for more details)
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
15.00 Spotlight PresentationThis slot is reserved for technology and service providers, please contact [email protected] for more info.
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
17.00 Chairperson’s Closing Remarks
To read the full abstract, please visit www.bpi-eu.com
4. MANUFACTURING, SINGLE-USE ANDQUALITY MANAGEMENTCONFERENCE DAY ONE: TUESDAY 14 APRIL 201507.30 Registration and Morning Coffee
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
11.30 Chairperson’s Opening Remarks
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
13.05 BPI Live Labs and Lunch
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
15.15 Spotlight PresentationThis slot is reserved for technology and service providers, please contact [email protected] for more info.
15.45 Afternoon Break
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
PREPARING FOR FUTURE PATIENT NEEDS17.35 Challenges and opportunities in vaccine manufacturing
Dr Rahul Singhvi, Chief Operating Officer, Takeda Vaccines, USA
18.05 Future of BiomedicinesDr Günter Jagschies, Strategic Customer Relations Lead, GE Healthcare, Sweden
18.35 Closing Remarks
18.40 Networking Drinks and Canapes followed by Wine Casino (see page 7 for more information)
19
CONFERENCE DAY TWO: WEDNESDAY 15 APRIL 2015
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
‘‘ ‘‘
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
11.00 Capacity, technology and innovation trends in a high variety product portfolio worldSimon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom
11.05 Chairperson's Opening Remarks
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
12.40 Lunch and Partnering Time
12.50 BPI Knowledge Exchange (see page 9 for more details)
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
15.00 Spotlight PresentationThis slot is reserved for technology and service providers, please contact [email protected] for more info.
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
17.00 Chairperson’s Closing Remarks
To read the full abstract, please visit www.bpi-eu.com
20
5. ANALYTICS, QUALITY CONTROLAND FORMULATIONCONFERENCE DAY ONE: TUESDAY 14 APRIL 201507.30 Registration and Morning Coffee
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
11.30 Chairperson’s Opening Remarks
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
13.05 BPI Live Labs and Lunch
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
15.15 Spotlight PresentationThis slot is reserved for technology and service providers, please contact [email protected] for more info.
15.45 Afternoon Break
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
PREPARING FOR FUTURE PATIENT NEEDS17.35 Challenges and opportunities in vaccine manufacturing
Dr Rahul Singhvi, Chief Operating Officer, Takeda Vaccines, USA
18.05 Future of BiomedicinesDr Günter Jagschies, Strategic Customer Relations Lead, GE Healthcare, Sweden
18.35 Closing Remarks
18.40 Networking Drinks and Canapes followed by Wine Casino (see page 7 for more information)
21
CONFERENCE DAY TWO: WEDNESDAY 15 APRIL 2015
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
‘‘ ‘‘
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
11.05 Chairperson's Opening Remarks
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
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 (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
15.00 Spotlight PresentationThis slot is reserved for technology and service providers, please contact [email protected] for more info.
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
To read the full abstract, please visit www.bpi-eu.com
22
E U R O P E A N S U M M I T
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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
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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
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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.
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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
E U R O P E A N S U M M I T
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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
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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
E U R O P E A N S U M M I T