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BioProcess InternationalConference & ExhibitionRegister by June 16, 2017AND RECEIVE UP TOSeptember 25-28, 2017 Hynes Convention Center Boston, MAPart of Biotech WeekBoston 600 SAVINGSTHE LARGEST BIOPROCESSING EVENT BRINGING YOU THESCIENCE, TECHNOLOGIES AND PARTNERS NEEDED TO ACCELERATEPROMISING BIOLOGICS TOWARDS COMMERCIAL SUCCESS1,800 BIOPROCESSING PROFESSIONALSAchieve clinical and commercial success by collaborating with leading pharma, biotechs,academia and solution providers from across the globe.225 TOP-LEVEL SPEAKERSImprove integration, productivity and cost savings in your current line of work by hearingcase studies and new data from experts working across the entire bioprocessing spectrum.160 EXHIBITORSAccelerate your drug product to market by accessing innovative products and technologiesin the largest exhibit hall devoted to biopharmaceutical manufacturing.100 PEER-SUBMITTED POSTERSStay at the forefront of bioprocess innovation by accessing unpublished data fromfellow BPI attendees.“The premier annual bioprocessing event for the developmentof biologics - covering critical CMC topics from cell culture,purification, formulation, and analytical through scale-up andproduction. The BPI conference is one meeting that everyonelooks forward to attending.””This conference is always a great opportunity toget a very comprehensive overview of new trends inbiologics process development, manufacturing aspectsand new trends in the biologics business.”Denny Kraichely, Ph.D., Johnson & JohnsonWolfgang Noe, Ph.D., Vice President, Bioprocess Development, BiogenEvent Partners:Register by June 16, 2017, and Save Up to 600 www.BPIevent.com
THE MOST INNOVATIVE SCIENCECapitalize on the latest case studies and newestdata direct from global thought leaders to improveintegration, productivity and cost effectiveness acrossthe bioprocessing spectrum. Your registration providesaccess to all five concurrent tracks covering the entirespectrum of biomanufacturing.THE LARGEST EXHIBITION DEVOTEDTO BIOMANUFACTURINGEvaluate next-generation tools and technologies from a globalnetwork of solutions providers to accelerate speed, efficiencyand ROI. View live technology demonstrations and discussyour business needs with 160 global solution providers for thebioprocessing industry.See Our Current Exhibitor List on Page 8THE RIGHT PARTNERS FOR YOUEstablish successful partnerships with innovators, suppliers,academia and associations to help you achieve commercialsuccess for your novel therapeutics. Evening cocktailreceptions and live entertainment events provide simpleyet-effective networking opportunities for you to meet thepartners you need to drive your business needs forward.NEW FOR BPI 2017New full day sessions covering: Viral Safety Biosimilar Development & Production Vaccine Development & Production Advanced Process Controls Innovations at the Interface of Upstream & DownstreamProcessing Registration for BPI now provides full access to the co-locatedCell & Gene Therapy BioProcessing & Commercialization meeting(www.CellGeneEvent.com) Expanded Exhibit Hall of Technology/Service Providers andExhibit Hall Presentations Women’s Leadership & Diversity in Biotech DayRegister by June 16, 2017, and Save Up to 600 www.BPIevent.com2
FIVE TRACKS COVERINGTHE ENTIRE BIOPROCESSINGSPECTRUMAttend any presentation across any trackto create a customized agenda that is mostrelevant to your line of work.MANUFACTURING STRATEGY Manufacturing Optimization and Process Intensification Manufacturing Case Studies of Complex, Novel and Niche Molecules New Concepts in Facility Design and Multi-Product Facilities Manufacturing for Legacy, Late Stage or Commercial Products Continuous Processing Integration in Biomanufacturing Raw Material Control; Single-use ImplementationDRUG PRODUCT, FILL FINISH & FORMULATIONS Novel and Adaptive Drug Product-Fill Finish Technologies Drug Product Process Validation and Control Strategies Alternative Protein Drying Technologies; New Trends in Lyophilization High Protein Concentration Formulations Formulations Strategies for Challenging and Complex Molecules Visual Inspections, Primary Packaging, Particulates and Container ClosureANALYTICAL & QUALITY Implementation of Novel Analytical Technologies for Biologics Analytical Strategies for Complex and Next-Generation Biologics High-throughput Analytical Methods and Automation Analytical Control Strategies and Analytics to Support Quality-by-Design Analytical Methods for Biosimilars and Glycan Analysis Quality Risk Assessments throughout the Product LifecycleCELL CULTURE & UPSTREAM PROCESSING Optimizing Transition from Discovery into Early Stage Development Applying Omics and Systems Biology Cell Line Development and Optimization Improving Efficiency, Productivity and Timelines in Cell Culture Integration of Analytical Methodologies and TechnologiesRECOVERY & PURIFICATION Innovations at the Interface of R&D, Harvest, and Formulations Advances in Analytical Development, PAT and QbD Novel Approaches for Non-Chromatographic Purification High-Throughput Process Development Process ModelingRegister by June 16, 2017, and Save Up to 600 www.BPIevent.com3
Preliminary AgendaMONDAY, SEPTEMBER 25, 2017PRE-CONFERENCE SYMPOSIA Continuous ProcessingMONDAY-TUESDAY, SEPTEMBER 25-26, 2017TWO-DAY TRAINING COURSES CMC Analytical, Comparability and Stability StudiesInstructor: Nadine Ritter, Ph.D., President and Analytical Advisor,Global Biotech Experts, LLC Vaccine Development and Production:Novel Technologies and Strategies Introduction to Biopharmaceutical Manufacturing Biosimilar Development and Production Modern CMC Regulatory Strategies and Insights Advanced Control Strategies in Bioprocessing andBiomanufacturing: Disruptive Technologies and EmergingPlatforms for Biologics Facilities of the FutureInstructors:Sheila G. Magil, Ph.D., Senior Consultant,BioProcess Technology ConsultantsFrank Riske, Ph.D., Senior Consultant,BioProcess Technology Consultants Cell-Based ImmunotherapiesMAIN CONFERENCE TUESDAY-THURSDAY, SEPTEMBER 26-28, 2017Keynote PresentationsImproving Global Access toBiotherapeutics through Molecule,Process and Manufacturing DesignDean K. Pettit, Ph.D.CSO and Founding Partner, Just BiotherapeuticsMANUFACTURING STRATEGY TRACKManufacturing Case Study in Raw Material and StorageConditionsBunyada Kwong, Engineer II, Manufacturing Sciences, Cell Culture,GenentechStrategies and Best Practices for Management, Assessmentand Implementation of Raw Material and ManufacturingChanges to Filters and Chromatography ResinsBernd Kraemer, Ph.D., Head Supplier Quality Management Americas,GenentechTools for Mapping and Repairing DiseaseStates: Can We Make TherapeuticInvention into a Mature Design Science?Ed Boyden, Ph.D.Associate Professor, Media Lab andMcGovern Institute, MITEnabling Flexibility in Supply Chain and ProductPresentation through Bulk Powder Drug SubstanceManufacturing of BiologicsKapil Gupta, Ph.D., Associate Director, Protein PharmaceuticalDevelopment, BiogenClosed Systems in CNC Ballroom, A Risk Based ApproachLars Hovmand-Lyster, Senior Engineering Specialist, Global ProjectOffice, Novo NordiskAdvanced Manufacturing Progress and Impact on USNational SecurityA Technology Roadmapping Process to Transform theBiopharmaceutical Manufacturing IndustryUdayanath Aich, Ph.D., Principal Scientist, Sanofi-GenzymeR. Thomas Warf, Director, Manufacturing, Facilities and Engineering,BARDAJean Hu-Primmer, Senior Advisor for CBRN and Pandemic Influenza,Office of Counterterrorism and Emerging Threats, US Food & DrugAdministrationEffectiveness of Raw Material Purity in Drug ProductManufacturingNext Generation Automation Enhances Single-use ProcessPlatformsSpeaker TBA, AvantorIntegration of Technology Transfer and Site Readiness toEnsure Successful Production CampaignChiali Liu, Ph.D., Principal Scientist, Technical Operations,Janssen Supply ChainRapid Prototyping Applications to Support TechnologyTransfers in the Commercial Manufacturing EnvironmentMiriam Monge, Director of Marketing Integrated Bioprocess Solutions,Sartorius Stedim BiotechThorsten Peuker, Ph.D., Vice President, Integrated Solutions SartoriusStedim BiotechChoosing the Right Biomanufacturing Strategy: DecisionPoints and Development Path ConsiderationsSteve Lam, Senior Vice President, Biologics, PatheonAndy Norriss, Senior Engineer, Materials Science, Genentech, Inc.Register by June 16, 2017, and Save Up to 600 www.BPIevent.com4
Preliminary Agenda (continued)MANUFACTURING STRATEGY TRACK (continued)Unexplored Benefits of Controlled Ice Nucleationduring LyophilizationControl of Raw Materials, Processes, Extractable andParticles Improves Single Use Compatibility with BiologicsShubhadra Singh, Ph.D., Investigator, Biopharm Product Sciences,GlaxoSmithKline R&DCase Study: Accelerated Late Phase Process Developmentand Transfer of a Mab Manufacturing ProcessEdwin Vilanova Velez, MSAT Engineer, Finished Goods, GenentechJean-Marc Cappia, Group Vice President Marketing & ProductManagement, Sartorius Stedim Biotech, FranceKathryn Aron, Senior Scientist, Process Development, Bristol-Myers SquibbFunctional Collaborations to Successfully Validate a MabProcess at a Contract Manufacturing SiteHarish Santhanam, Associate Engineering Advisor, BiotechManufacturing, Eli Lilly, IrelandComplex Resolution of a Product Quality Issue for aCommercial ProductPeter Wojciechowski, Ph.D., Head, Process Investigation andInnovation, ShirePitfalls of Back To Back Technology Transfers from anEstablished Ds Manufacturing Production Site to a NonLicensed FacilityLisa Day, Engineer, Manufacturing Sciences, GenentechOverview of Current Drivers of Vaccine ManufacturingDevelopment from Facility, Technological, Regulatory andAnalytical PerspectivesJoshua Speidel, Ph.D., Managing Director, Commercial Practice Lead,Latham BioPharm Group, Inc.Case Study Using Bio-Analytical Comparability forLicensure of a Vaccine Manufacturing FacilityIndresh Srivastava, Ph.D., Vice President, Process & Analytical Development,Senior Program Manager – Influenza, Protein Sciences CorporationPANEL DISCUSSION: The Future of VaccineAntigen ManufacturingPanelist: Mario Barro, Ph.D., Senior Director, Innovation, Sanofi PasteurVaccine Delivery and Device InnovationDarin Zehrung, Senior Technical Officer & Portfolio Leader, Vaccine andPharmaceutical Delivery Technologies, PATHPANEL DISCUSSION: Global Health Vaccine ManufacturingChallenges: Innovation to Support Reduced Cost of GoodsSubhash Kapre, Ph.D., CEO, InventpriseDRUG PRODUCT, FILL FINISH &FORMULATIONS TRACKUnexpected Findings Discovered during the FormulationDevelopment of a Freeze-dried Ebola-ExpressingAdenoviral Vector (ChAd3-EBOZ)Quantify Pressure Distribution in the Filling Line - PressureAnalysis by In-Line MonitoringCase Studies on the Impact of Changes of Drug Substanceon Final Fill-finish ProductShen Chen, Ph.D., Director, PEH Pharm Sci, Pfizer CentreOne R&DCriticality of Equipment Design on Protein Product Qualityduring Drug Product Manufacturing: A Case StudyBenson Gikanga, Engineer II, Pharmaceutical Processing andTechnology Development, GenentechBulk Freezing in Shelf-Life Extension and Drug ProductManufacturingMark Yang, Ph.D., Director of Fill Finish Development,Pharma Development Biologics, SanofiSatisfying Very-high Dose Needs of Biologics: Ultra-highConcentration Formulation Development, Manufacturingand DeliveryVineet Kumar, Ph.D., Principal Scientist, Drug Product Development,Johnson and JohnsonEnabling Flexibility in Supply Chain and ProductPresentation through Bulk Powder Drug SubstanceManufacturing of BiologicsKapil Gupta, Ph.D., Associate Director, Protein PharmaceuticalDevelopment, BiogenChanging Development Paradigms using PredictiveModeling in Drug Product OperationsSuresh Nulu, Senior Engineer II, Parenteral Process Development, BiogenParticulate Formation During Product End-use:Characterizing Nano- and Sub-visible ParticlesVivek Kumar Garripelli, Ph.D., Senior Scientist II, Biologics FormulationDevelopment, AbbVieA Practical Approach for Assessing the Impact of Visibleand Ultraviolet Radiations on BiomoleculesGanapathy Gopalrathnam, Principal Research Scientist, Lilly ResearchLaboratories, Eli Lilly and CompanyPANEL DISCUSSION: How to Mitigate Drug ProductTechnical ChallengesPanelists TBAA Risk-Based Process Control Strategy for Low EndotoxinDrug Product ManufacturingRobert Simler, Associate Director, BiogenFrédéric Mathot, Ph.D., Senior Scientist, Drug Product R&D – GlobalVaccines Technical R&D, GlaxoSmithKline Vaccines, BelgiumCase Studies Demonstrating Challenges, Solutions, andProcess Improvements Associated with the Drug ProductManufacturing Process of BiopharmaceuticalsJames Colandene, Ph.D., Manager, Biopharmaceutical ProductSciences, GlaxoSmithKlineRegister by June 16, 2017, and Save Up to 600 www.BPIevent.com5
Preliminary Agenda (continued)ANALYTICAL & QUALITY TRACKEvaluation of Analytical Methods for High-throughputGlycan AnalysisAshley Wilson, Development Associate III, Analytical andPharmaceutical Sciences, ImmunoGen, Inc.Multi-Variate Data Analysis and its Potential Contributionto QualityRandall Kilty, Technology Scientist/Process Engineer, PfizerPhase-appropriate Approaches to Streamlining BioassayTestingTariq Warsi, Ph.D., Senior Scientist, Process Development. AmgenAdvances and Challenges in the AnalyticalCharacterization of Biosimilar ProductsAnalytical Comparability Strategies for BiosimilarsJeff Allen, Ph.D., Biosimilar Sciences Fellow, PfenexAnna Schwendeman, Ph.D., Assistant Professor,Pharmaceutical Sciences, University of MichiganMonitoring of Methionine Oxidation in Antibody-drugConjugates (ADCs) by UV-UPLCGeneral Strategies for Characterization of SubvisibleParticles(SVP) Based on Product Specific SVP LibraryAlexandra Zaitsev, Development Associate II, Analytical &Pharmaceutical Sciences, ImmunoGen, Inc.Particulate Formation During Product End-use:Characterizing Nano- and Sub-visible ParticlesVivek Kumar Garripelli, Ph.D., Senior Scientist II, Biologics FormulationDevelopment, AbbViePotential Impact of Nano Particulate Impurities fromSugars on Therapeutic ProteinsAnant Sharma, Formulation Scientist, Eli Lilly & CompanyIntegrating Novel Analytical Tools into DevelopmentWorkflow of Biologics: nanoDSF and MST for Discovery,Development and QCAlexey Rak, Ph.D., Head of Bio Structure and Biophysics, Sanofi R&D,FranceDevelopment of Multiplex Sensitive Anti-drug-antibody(ADA) Assays for CRISPR/Cas9 Genomic MedicinesYu Hayashi, Researcher, Astellas Pharma, JapanRECOVERY & PURIFICATION TRACKVirus Filtration: Throughput Comparison of CommercialFilters and Development of New Prefiltration StrategyDr. Abhijit Shrike, Scientist, Teva PharmaceuticalsEvaluating Novel Harvest Methods for High Density CellCulture ProcessesMahsa Rohani, Scientist, AmgenA Comprehensive Regeneration Strategy for Protein anAffinity Resin in Monoclonal Antibody (mAb) PurificationLu Wang, Senior Scientist, Teva PharmaceuticalsMulti-target Approach to Affinity Purification ofRecombinant ProteinsAndrew Keefe, Senior Downstream Development Engineer, ShireJunxia Wang, M.D., Ph.D., Associate Director, Immunosafety andBioanalytical Development, Editas MedicineReduction of Process Related Impurities in Ocular TherapeuticsMulti-attribute MonitoringSelectivity Analysis of Multimodal Cation-ExchangeChromatography on Protein Impurity SeparationRich Rogers, Scientist, Just BiotherapeuticsSpecifications and Change Control across theProduct LifecycleMelissa Morandi, Vice President, Global Quality, AegerionPharmaceuticalsPANEL DISCUSSION: In-country Release Testing andMethod TransferPanelist: Melissa Morandi, Vice President, Global Quality,Aegerion PharmaceuticalsAnalytical CMC Considerations for BiotherapeuticsNadine Ritter, Ph.D., President and Analytical Advisor,Global Biotech Experts, LLCNanofluidic Device Enabling Real-time Product QualityAssessments in Biomanufacturing SystemSung Hee Ko, Ph.D., Postdoctoral Fellow,Massachusetts Institute of TechnologyNicole Lee, Sr. Research Associate, Genentech IncKeith Selvitelli, Senior Associate Scientist, BiogenRemoval of CHO Protein - Phospholipase B-Like 2 (PLBL2)during Downstream Processing of a Monoclonal AntibodyMukesh Mayani, Scientist II (Process Development),Bristol-Myers SquibbPurification Process Development for a Light-SensitiveMonoclonal AntibodyNathaniel Macapagal, Scientist I, MedimmuneCharacterization of a Recombinant Enzyme DownstreamProcess Using Modern DOE TechniquesMichael Coolbaugh, Scientist, SanofiImpact of Depth Filtration on Monoclonal AntibodyInterchain Di-Sulfide Bond Stability during DownstreamProcessing from CHO Cell CulturesManju Kuruganti, Scientist, Bristol-Myers SquibbTransforming Deviation Management using a Proven RiskBased ApproachBrian Chviruk Associate Director of Investigations, ProductionTechnical Support, ShireJay Antonetti, Associate Director of Quality Assurance, SanofiRegister by June 16, 2017, and Save Up to 600 www.BPIevent.com6
Preliminary Agenda (continued)RECOVERY & PURIFICATION TRACK (continued)Acoustic Wave Separation as a Novel ClarificationTechnique for the Removal of Aggregate–EnrichedCalcium Phosphate Precipitates during BispecificAntibody PurificationLindsay Arnold, Scientist, MedImmuneThe Link between Protein A Eluate Turbidity and VirusFiltration FoulingRobert Duffy, Principal Scientist, AbbVieFlow-through Versus Bind-and-Elute: an AlternativeStrategy for Improved Robustness and Manufacturabilityfor a Challenging Cation Exchange ChromatographyJessica Prentice, Associate Scientist, MedImmuneOptimization of Manufacturing Operations and TimelinesDriven Through the Pilot Scale PlantDouglas Osborne, Senior Manager, BiogenCELL CULTURE & UPSTREAM PROCESSING TRACKProcess Performance and Product Quality ComparisonBetween Fed-Batch and Perfusion Cell Culture SystemMyles Hollenbach, Process Engineer 1, SanofiHow to Measure and Harness CHO Cell Genetic/FunctionalInstability for Improved Cell Factory PerformanceDr. David Jones, Professor of Bioprocess Engineering,University of SheffieldOptimization of Manufacturing Operations and TimelinesDriven Through the Pilot Scale PlantDouglas Osborne, Senior Manager, BiogenProcess Optimization and Scale-up Challenges in theDevelopment of a Large-scale Chemically-defined PhaseIII/Commercial Manufacturing Cell Culture ProcessJason Goodrick, Senior Engineer, GenentechHow to Measure and Harness CHO Cell Genetic/FunctionalInstability for Improved Cell Factory PerformanceDavid James, Professor of Bioprocess Engineering,University of SheffieldA Novel Integrated End-To-End Workflow SystemSupporting High Throughput Cell Line and Scale-DownUpstream Process ScreeningChristoph Freiberg, Senior Scientific Consultant, GenedataImproving Antibody Titers through Media and ProcessImprovements, While Maintaining Product QualityAttributesEvaluating the Effect of Poloxamers on DNATransfection MethodsRachel Fergeson, Associate Scientist, BiogenEvaluate Thermo 30L Single Use Bioreactor for Seed Trainand Inoculum TrainEdward Chan, Technical Engineer II, Genentech, IncScale-down Model of N-1 Perfusion Seed Bioreactor forHigh-Throughput AnalysisYongqi Wu, Scientist, Bristol-Myers SquibbA Fresh Approach to Process Characterization Through theUse of New Tools and TechnologiesRita Barros Costa, Senior Group Leader, Lonza BiologicsINTERFACE BETWEEN UPSTREAM & DOWNSTREAMPROCESSING (Shared Track)How Low Can We Go; Application of Multimodal CationExchange Chromatography for Reduction of HCP and HighMolecular Weight Species for Non-IgG PurificationZahira Begum, Senior Research Associate, Genentech Inc.Leverage Partnership, Technical Development andManufacture to Deliver Next Generation High TiterBiologics ProductionHaofan Peng, Senior Engineer II, BiogenAccelerating Upstream Process Characterization usingEfficient Experimental DesignsKarna Shah, Manufacturing Sciences, Cell
BioProcess Technology Consultants Frank Riske, Ph.D., Senior Consultant, BioProcess Technology Consultants MONDAY, SEPTEMBER 25, 2017 PRE-CONFERENCE SYMPOSIA Continuous Processing Vaccine Development and Production: Novel Technologies and Strategies Biosimilar Development and Production Modern CMC Regulatory Strategies and Insights
