Drive Efficiencies in Your Bioprocesses: 10 Solutions You Need ...

Understand and Plan for the Most Crucial Future Industry TrendsConference: September 16-19, 2013Exhibition: September 17-19, 2013Hynes Convention Center • Boston, MADear Colleagues,Please join us in Boston this September to celebrate the 10th Anniversary of IBC’s BioProcess International Conference & Exhibition- a milestone event providing the tools and knowledge you need to meet the demands of increasingly diverse product portfolios in anever-evolving biomanufacturing landscape.The inaugural BPI Conference in 2004 was one of the industry’s first opportunities to exchange experiences and knowledge to optimizemanufacturing processes and accelerate programs. Fast forward 10 years and the BPI Conference has become THE industry meetingplace for product and process development and biomanufacturing scientists and executives to share technical, scientific and strategicsolutions across all phases of bioprocess development.IBC Life Sciences and our colleagues at BioProcess International magazine are proud to announce this year’s program. This Septemberis your opportunity to join more than 1500 of your colleagues in Boston to find superior tools and practical knowledge to help youaccelerate your bioprocess development efforts. Here is just a sample of what you will learn by attending:Gain Practical Tools from Five In-Depth Pre-Conference Symposia• Antibody-Drug Conjugates: Current Best Practice and Considerations for Processes and Facilities• Knowledge & Data Management for Process Development & Manufacturing• Biological Assay Development• Achieving Supply Chain Transparency for Raw Materials• Product- and Process-Related Variants & ImpuritiesHear Exclusive Case Studies and Unpublished Data in Five Conference Tracks• Upstream strategies for flocculation and perfusion processes, maximizing throughput, and production of new modalities• Downstream techniques on fully disposable clarification, non-affinity based purification, mixed-mode chromatography andcontinuous processing• Strategies for achieving and delivering stable and high-protein concentration formulations• Analytical methods for comparability/similarity and quality approaches for improved product and process control• Manufacturing strategies to improve efficiency and capacity utilization and lessons from flexible facility designs andsingle-use implementationsParticipate in Provocative Discussions Designed for Audience Interaction• Maximizing Limited Bandwidth for Beta Testing of New Technologies• Product Attribute Control (PAC): A Future Vision for Protein Process Development• Harmonization of Single-Use Systems: Extractables & Leachables• What Does Robust Supply Chain Transparency Look Like?• Capture Options in Antibody Purification: Current Limitations, Emerging Options and Obstacles to ChangeWe look forward to your attendance and enthusiastic participation at BPI 2013 this September. And remember, the sooner youregister, the more you save. Your attendance prepares your bioprocess operations for success in the highly dynamic market for biologics.See you in Boston!Sincerely,Conference Director Conference Director Conference ProducerIBC Life Sciences IBC Life Sciences IBC Life SciencesP.S. Interested in seeing the industry advancements discussed at BPI over the past 10 years?Visit www.IBCLifeSciences.com/BPI to review the BPI conference brochures from 2004 to today.2Reserve Your Seat Today! Call (800) 390-4078 or E-mail reg@ibcusa.com

Monday, September 16, 2013 • Pre-Conference SymposiaAM Antibody-Drug Conjugates:Current Best Practice andConsiderations for Processes andPMFacilitiesBiological Assay DevelopmentAgenda-at-a-GlanceAchieving Supply ChainTransparency for Raw MaterialsKnowledge & Data Managementfor Process Development &ManufacturingProduct/Process RelatedImpurities & VariantsTwo-Day Training CoursesTuesday, September 17, 2013 • Main ConferenceExhibit Hall & Poster Viewing Hours: 3:15 pm - 7:15 pmCell Culture &Recovery & Purification Formulation and Delivery Manufacturing Strategy Analytical & QualityUpstream ProcessingCell Metabolism and Physiology –New Paradigm Continuous Particle Identification and Maximizing Manufacturing Balancing Analytical RequirementsTwo-Day Training CoursesAM Impact on ProductionProcessing in Biomanufacturing Characterization for Realizing Efficiency and Capacity Utilization with Limited ResourcesSponsored by: Life TechnologiesNon-Chromatographic Methods – Stable, Safe and EffectiveManufacturing Strategy Comparability and SimilarityRevisiting the Past?Formulationand PlanningAnalytical Strategies for BiosimilarsTechnology Workshops sponsored by: GE Healthcare, Irvine Scientific, Novasep, PerkinElmer, Sartorius StedimLuncheon Presentation Sponsored by: EMD MilliporePMImproving Speed and Quality ofCell Line DevelopmentPoint-Counterpoint Discussion– Capture Options in AntibodyPurificationAnalytical Strategies forDetermining Formulation StabilityStrategic Discussion andBrainstorm SessionGrand Opening of the Poster & Exhibit Hall with refreshments Sponsored by: Pall Life SciencesKeynote PresentationsOktoberfest Reception in the Poster & Exhibit Hall Sponsored by: Roche Custom BiotechAnalytical Technologies forDiverse MoleculesWednesday, September 18, 2013 • Main ConferenceTechnology Workshop with continental breakfast Sponsored by: Repligen BioprocessingCell Culture &Recovery & Purification Formulation and Delivery Manufacturing Strategy Analytical & QualityUpstream ProcessingProduct Attribute Control: A Future Vision for Protein Process Development and ManufacturingAM Consistency Through ControlPurification Advances UsingFlexible Facilities, Multi-Productof Raw Materials and MediaMixed-Mode Chromatography Strategies for Achieving Stability and Single-Use Implementation: Product Attribute Control (PAC): AOptimizationSponsored by: Bio-Rad Laboratories for High-Protein Concentration Practical Experience and Future Vision for Protein ProcessSponsored by: BD BiosciencesFormulationsLessons LearnedDevelopment and ManufacturingSponsored by: Pall Life SciencesTechnology Workshops sponsored by: Avid Bioservices, EMD Millipore, GE Healthcare, Saint Gobain, Corning IncorporatedNetworking Luncheon in Exhibit/Poster Hall with Dedicated Poster ViewingPMImplementing FlexibleManufacturing in UpstreamProcessingPurification Strategies for NovelModalities and High Density CellCultureAnalytical Strategies forSynchronized Formulation andDevice DevelopmentFlexible Facilities, Multi-Productand Single-Use Implementation:Practical Experience andLessons LearnedSponsored by: Pall Life SciencesKeynote PresentationsMixed-Mode Mixer Reception in the Poster & Exhibit Hall co-sponsored by: Bio-Rad LaboratoriesTwo-Day Training CoursesTwo-Day Training CoursesExhibit Hall & Poster Viewing Hours: 9:45 am - 7:00 pmAdvanced Analytics andInnovative TechnologiesThursday, September 19, 2013 • Main ConferenceExhibit Hall & Poster Viewing Hours:10:15 am - 1:40 pmCell Culture &Upstream ProcessingRecovery & Purification Formulation and Delivery Manufacturing Strategy Analytical & QualityInnovation at the Interface of Upstream and Downstream Processing Strategies for Achieving StabilityAMExpanding the Tool Box –for High-Protein Concentration Single-Use Innovations in CriticalQuality Risk Management andBeyond Antibodies – Novel Purification Methods and Biosimilar Formulation and and High-value ApplicationsQuality AuditingProduction of New Modalities Single-Use Applications QbD Considerations for Biologic Sponsored by: Thermo ScientificSponsored by: Life TechnologiesDevelopmentTechnology Workshops sponsored by: 3M, EMD Millipore, SAFC /BioReliance, TAP Biosystems,Networking Luncheon in the Exhibit/Poster HallPMControl of Process andProduct QualityModels for Perfusion andFed Batch ProcessesExpanding the Tool Box –Novel Purification Methods andSingle-Use ApplicationsAdvances in Analytics & Models to AidDownstream Process DevelopmentBiosimilar Formulation and QbDConsideration for BiologicalDevelopmentLocalized and Targeted DeliveryStrategiesManufacturing Technologies toImprove Efficiency and ControlTown Hall Forum: Harmonizationof Single-Use Systems: Extractables& Leachables and other InitiativesControl of Process andProduct QualityAdvances in Analytics and Modelsto Aid DownstreamProcess DevelopmentVaccine Development& ProductionHigh-Concentration VaccineDelivery, Formulation andNovel AdjuvantsVaccine Manufacturingand ProductionIndexPoster Presentations ........ 4Pre-Conference Symposia .. 6-7Two-Day Training Courses .... 7Main Conference Agenda . 8-19Sponsors/Exhibitors. .... 20-21Networking Opportunities ..22Registration Information ...23Producing High Quality, Low CostBiotherapeutics in the Century of BiologyJames Thomas, Ph.D. / Amgen, Inc.Vice President, Process and Product Development and WA Site HeadTransforming the Development of BiotechnologyDrugs for the 21st Century: A CEO’s Perspectivefrom a Small Biotech CompanyAbbie Celniker, Ph.D. / Eleven BiotherapeuticsCEOPerspectives from VisionaryKeynote SpeakersA Systems Approach to ManagingBiomanufacturing Complexity –Genzyme’s Allston Plant Case StudySandra Poole / GenzymeSenior Vice President Biologics OperationsBiologics Manufacturing in a RapidlyChanging EnvironmentPeter Moesta, Ph.D. / Bristol-Myers SquibbSenior Vice President, Biologics Manufacturing& Process DevelopmentEliminating Interfaces: Process DevelopmentLessons from Aggressive Platform DevelopmentLars Pampel, Ph.D. / Novartis Pharma AG, SwitzerlandGroup Head, Early Phase Process DevelopmentVisit www.IBCLifeSciences.com/BPI for Full Abstracts and Up-To-Date Information3

Where Industry Connects to Share Technical, Scientific andCovering theFull BioprocessSpectrumUpstreamProcessingDownstreamProcessingPresent a Poster• Utilize process and product understanding withquality risk management to enable an adaptivemanufacturing process• Apply cell-free protein synthesis for rapid designand manufacture of homogeneous proteintherapeutics• Collaborate with key suppliers to improvesupply chain transparency• Foster speed and flexibility with single-usebioreactors in clinical manufacturing• Novel “fully” disposable clarification solutionto harvesting of untreated and flocculated highcell density feeds• Critical parameters to examine whenmodeling perfusion processes and using themto understand the impact on harvest andpurification rates• Fast approach to identify reliable targetintegration hosts from limited genomescreening• Integrate disposables into a stainless steelmulti-product facility• Novel non-affinity based purification proceduresthat offer higher productivity and lower cost thanProtein A based platforms• Development of novel and efficient cell cultureflocculation to help streamline antibodypurification• Utilize membrane absorbers for both directcapturing and flowthrough polishing of complexrecombinant proteins and monoclonal antibodies• Integration of HIC and multimodalchromatography in the purification ofbioconjugate whose components are expressedin E.coli and CHO• Head-to-head comparison of the disc stackand fluidized bed centrifuges for clarificationefficiency, product recovery (yield) and cost tooperate• Enabling continuous processing with single-useapplications that provide significant throughputimprovements• Overcome bispecific antibody purificationchallenges using novel mixed modechromatographyConsider presenting a poster at this conference to derive more value from attending.Share your research with your peers and learn from other posters as well. Many attendeestell us that being selected for a poster presentation helps to facilitate their companyapprove process to attend the conference.Best Poster Award Sponsored by:All poster abstracts received by August 19, 2013 and presented at the 2013 BioProcessInternational Conference and Exhibition are automatically eligible for the Poster Awardcompetition. Posters will be reviewed and judged by BioProcess International’s Editor-in-Chief and Scientific Advisory Board.Two winning posters, one academia/industry and one supplier, will be announced at theconference. The two winning posters will be featured in and linked from BPI’s October2013 Poster Hall eNewsletter, published in BPI’s November 2013 Interactive Poster HallSupplement, and will be posted on a dedicated landing page with your pre-recordedpodcast presentation on bioprocessintl.com/posters for a full year.How to submit your poster: To submit your poster and for additional details on deadlinesand the poster size and regulations, please visit: www.IBCLifeSciences.com/BPI/poster.xmlPoster abstract submission deadlines:1) For inclusion in BPI Conference Preview Issue: July 31, 20132) For Inclusion in On-site Agenda and Conference Documentation:August 19, 2013Dedicated Poster Viewing HoursPoster presentations will be on display at all times during exhibit hall viewing hours. Posterpresenters may stand by their posters at any time, but to ensure that attendees are able to meetposter presenters at specific times during the conference, we have designated the following days/times as “Dedicated Poster Viewing” Hours.We ask all poster presenters to stand by their posters during the dedicated hours listed below forodd/even numbered posters, to make it easy for attendees to “find” you. We will be promotingthese dedicated poster viewing hours during the conference to facilitate better attendee andposter presenter interactions and discussions.Dedicated Poster Viewing Hours for Even Numbered Posters (2,4,6, etc.)Even numbered poster presenters should stand by their posters at the following times:Tuesday, September 17: 6:15-7:00 pm (during the cocktail reception)Wednesday, September 18: 12:45-1:30 pm (during the lunch break)In addition, even numbered poster presenters may also feel free to stand by their posters at anyother time during exhibit hall opening hours.Dedicated Poster Viewing Hours for Odd Numbered Posters (1,3,5, etc.)Odd numbered poster presenters should stand by their posters at the following times:Wednesday, September 18: 6:00-6:45 pm (during the cocktail reception)Thursday, September 19: 12:45-1:30 (during the lunch break)In addition, odd numbered poster presenters may also feel free to stand by their posters at anyother time during exhibit hall opening hours.General Exhibit Opening HoursTuesday, September 17, 2013: 3:15 pm - 7:15 pmWednesday, September 18, 2013: 9:45 am - 7:00 pmThursday, September 19, 2013: 10:15 am - 1:40 pm4Reserve Your Seat Today! Call (800) 390-4078 or E-mail reg@ibcusa.com

Strategic Solutions across All Phases of BioProcess DevelopmentFormulation& DeliveryManufacturingClinical &CommercialAnalytical& Quality• Get FDA perspective on the influenceof aggregation and immunogenicitywhen formulating biologics and proteintherapeutics• Acquire predictive tools to achievestable and high-protein concentrationformulations for effective and deliverableprotein therapeutics• Learn valuable strategies and approachesto make the most of using biosimilars inprotein therapeutic formulation• Overcome challenges in formulation anddevice integration for safe and effectivetarget doses and timely market delivery• Hear the latest formulationconsiderations to advance thedevelopment of inhalable biologics• Maximize manufacturing efficiencies andcapacity utilization in both clinical andcommercial facilities• Leverage your limited bandwidth for betatestingof new technologies to help youprioritize what’s most important• Learn the state-of the-art in flexibleand multi-product facility designs andimplementation• Hear the latest innovations in singleusetechnologies including practicalimplementation challenges• Participate in a town hall forum onharmonization of single-use systems withrepresentatives of BPSA, ASTM, ASME BPE,PDA, BPOG and ISPE• Find the right balancing act betweenanalytical testing requirements and limitedresources so you know what to do and when• Discover new strategies for comparabilityand similarity testing of diverse productsand processes• Learn about a future vision for proteinprocess development and manufacturingfocusing on product attribute control• Implement quality risk assessment andquality auditing methods to improveplanning and regulatory success• Evaluate new analytical technologies andquality approaches in both upstream anddownstream development to improveprocess and product control“This conference is both a great opportunity for ‘newbies’ in thefield to get a great perspective as well as ‘veterans’ to have a forumfor sharing the latest advances and learnings.”- Elizabeth C. Dodson, Manager R&D, BD Biosciences“BPI is a great opportunity to meet leaders,and innovators in this industry.”Margit Holzer, VP R&D and Technology, NovasepNetworking Made Easy• Speed networking session in the exhibit hall so you can make valuable newcontacts to help you accelerate your bioprocessing projects.• Dedicated poster viewing times to facilitate networking with otherattendees so you can share research ideas and strategies, as well as technicalchallenges and solutions.• Interactive discussion sessions are designed for audience involvement, soyou can ask your questions to expert panelists and participate in the debate.• Networking cocktail receptions and multiple networking coffee breaksand luncheons are designed to facilitate cross-disciplinary exchange amongattendees of all conference tracks.• More than 150 exhibitors and technology providers in the exhibit hall,offering you a one-stop-shop opportunity to network with every majorbioprocess solution provider in the field.New for 2013: BPI ConnectThe Partnering Tool and Conference App to EnhanceYour Experience Before, During and After the Event• Pre-schedule meetings with attendees, speakers and exhibitors• Plan your onsite conference session agenda• Interactive exhibit and poster hall navigation tool• Get regular updates announcing agenda changes and onsite activitiesVisit www.IBCLifeSciences.com/BPI for Full Abstracts and Up-To-Date Information5

Tuesday, September 17, 2013 • Main ConferenceFormulation and Delivery Analytical and Quality Manufacturing Strategy1:30 Chairman’s RemarksArvind Srivastava, Ph.D., Director, FormulationDevelopment, ImClone SystemsAnalytical Strategies forDetermining Formulation Stability1:45 CASE STUDY/UNPUBLISHED DATA Freeze- ThawConsiderations for Biopharmaceuticals:A Controlled Small Scale ApproachManasi Puri, Scientist, Biopharmaceutical Technologies,Biopharmaceutical Unit R&D, GlaxoSmithKline2:15 Risk Assessment and Stability Study Designto Manage Temperature Excursions forProtein TherapeuticsArvind Srivastava, Ph.D., Director, FormulationDevelopment, ImClone SystemsChairman’s RemarksMarc Thorsteinsson, Ph.D., Research Fellow, VaccineAnalytical Development, Merck & Co., Inc.Analytical Technologies forDiverse MoleculesCASE STUDY/UNPUBLISHED DATA Understandingthe Unique Structure/Function Aspects ofRecombinant EnzymesJohnson Varghese, Ph.D., Director/Head, AnalyticalDevelopment, Shire HGTCASE STUDY Analytical CharacterizationStrategies for ADCsMaureen Fitch Bruhns, Ph.D., Senior Scientist,Analytical Development, Process Development, IgenicaChairman’s RemarksPeter Latham, President, Latham BioPharm GroupStrategic Discussion andBrainstorm SessionHow to Maximize your Limited Bandwidthfor Beta Testing of BiomanufacturingTechnologies?In cooperation with:Moderator:Peter Latham, President, Latham BioPharm GroupPanelists:Brian Caine, Publisher, BioProcess InternationalDavid W. Kahn, Ph.D., Senior Director,GlaxoSmithKlineCharles Sardonini, Ph.D., Associate Director, ProcessEngineering/Development, Genzyme, a Sanofi Company2:45 CASE STUDY/UNPUBLISHED DATA Formulation andDelivery Approaches Through Rational Approachesto Developabilty and Manufacturability /Integrating Device Development Into EffectiveFormulation DevelopmentNishant Bhasin, Ph.D. Global Drug Product Integrator,Johnson & Johnson3:15CASE STUDY/UNPUBLISHED DATA Identification andAnalytical Investigation of a ProteaseContaminant in a Commercially PurchasedBioprocess BufferMarc Thorsteinsson, Ph.D., Research Fellow, VaccineAnalytical Development, Merck & Co., Inc.Grand Opening of the Poster and Exhibit Hall with refreshments Sponsored by:Keynote Presentations4:00 Chairman’s RemarksRohin Mhatre, Ph.D., Vice President, BioPharma Development, Biogen Idec4:15Producing High Quality, Low Cost Biotherapeutics in the Century of BiologyJames Thomas, Ph.D., Vice President, Process and Product Development and WA Site Head, Amgen, Inc.4:50A Systems Approach to Managing Biomanufacturing Complexity – Genzyme’s Allston Plant Case StudySandra Poole, Senior Vice President Biologics Operations, Genzyme5:25 Transforming the Development of Biotechnology Drugs for the 21st Century:A CEO’s Perspective from a Small Biotech CompanyAbbie Celniker, Ph.D., CEO, Eleven Biotherapeutic6:00Oktoberfest Reception in Poster and Exhibit Hall Sponsored by:Founding Publication:BioProcess International provides the global biotechnology industry with peer-reviewed informationessential to successfully drive products through the biotherapeutic development and manufacturingprocess. To reserve your subscription go to http://bit.ly/Z8US8O or scan the following code:Association Partners:Media Partners:Bioprocessing EquipmentStandard (BPE)IBC is a ProudSponsor ofVisit www.IBCLifeSciences.com/BPI for Full Abstracts and Up-To-Date Information11

Wednesday, September 18, 2013 • Main ConferenceCell Culture Recovery & Purification Vaccine Development & Production7:30 Coffee7:30 Technology Workshop with Light Continental BreakfastImplementing Disposable Chromatography: Technology Fit in Downstream Purification Fletcher L. Malcolm, Associate Director, Product Management & Marketing, Repligen Corporation8:00 Chairwoman’s Opening RemarksChairman’s RemarksKathie Fritchman, Scientific & Applications Manager, Carsten Voss, Ph.D., Application Specialist, ProcessBD Biosciences-Advanced BioprocessingChromatography, Bio-Rad Laboratories, GermanyConsistency Through Control of RawMaterials and Media OptimizationSponsored by:8:15 (8:05) CASE STUDY/UNPUBLISHED DATAControlling Process Variability due to RawMaterial VariabilityDave Kolwyck, M.S., MBA, Principal Scientist, MaterialScience, Amgen Inc.(8:30) CASE STUDY/UNPUBLISHED DATA Detection ofVesivirus 2117 in Bovine Serum Using aValidated RT-PCR Limit TestFrancis Poulin, Ph.D., Staff Scientist AnalyticalDevelopment, Genzyme, A Sanofi Company8:45 (8:55) CASE STUDY/UNPUBLISHED DATA A Scale DownModel to Test Raw Material VariabilityHaofan (Eric) Peng, Senior Engineer I, Cell Culturedevelopment, Biogen Idec9:15 (9:20) CASE STUDY/UNPUBLISHED DATAChemically Defined Media Optimization:Challenges and SolutionsJames Brooks, Ph.D., R&D Manager,BD Biosciences-Advanced Bioprocessing9:45Purification Advances usingMixed-Mode ChromatographySponsored by:(8:05) UNPUBLISHED DATA Molecular Insights intoMultimodal ChromatographySteven Cramer, Ph.D., Walker Professor,Department of Chemical and Biological Engineering,Rensselaer Polytechnic Institute(8:30) CASE STUDY/UNPUBLISHED DATA Characterizationof the Parameters and Interactions Affecting thePerformance of Hydroxyapatite Chromatography– An Experimental Enzyme Case StudyBen Simeone, Senior Process Development Engineer II,Shire Pharmaceuticals(8:55) CASE STUDY/UNPUBLISHED DATA Mixed-ModeChromatography Technology in MonoclonalAntibody Downstream Purification ProcessJie Chen, MD, M.S., Director of Protein Sciences, Dyax Corp.(9:20) CASE STUDY/UNPUBLISHED DATA OvercomingProteolytic Degradation During thePurification of a Therapeutic GlycoproteinXuemei He, Ph.D., Senior Staff Scientist, ProcessChromatography Applications, Bio-Rad LaboratoriesNetworking Refreshment Break in Poster and Exhibit Hall Sponsored by:Sponsored by:Chairman’s RemarksIndresh Srivastava, Ph.D., Vice President, ProductRealization, and Senior Project Manager, ProteinSciences Corp.Featured PresentationFlublok ® : Developing the World’s FirstRecombinant, Highly Purified, Egg-FreeInfluenza VaccineMireli Fino, Vice President, Manufacturing Operations,Protein Sciences CorporationHigh-Concentration Vaccine Delivery,Formulation and Novel AdjuvantsPreparation of Highly Concentrated InfluenzaVaccine for Use in Novel Delivery ApproachesSushma Kommareddy, Research Investigator,Novartis Vaccines & DiagnosticsFormulation of the Next Generation ofVaccine Adjuvants and Delivery SystemsDerek O’Hagan, Ph.D., Global Head of VaccineDelivery Research, Novartis Vaccines & DiagnosticsMethods and Strategies toMaximize Throughput ofHigher Titer Processes andCulture IntensificationPurification Advances usingMixed-Mode Chromatography(continued)High-ConcentrationVaccine Delivery, Formulationand Novel Adjuvants(continued)0:30 How to Introduce Perfusion into aFed-Batch Manufacturing EnvironmentBruno Figueroa, Ph.D., Senior Principal Scientist,Bioprocess R&D, Pfizer Inc.1:00 CASE STUDY/UNPUBLISHED DATA Strategies toOptimize a Perfusion Cell Culture Process forthe Production of a Monoclonal AntibodyHang Zhou, Ph.D., Process Engineer II, Commercial CellCulture Development, Genzyme, A Sanofi Company1:30 UNPUBLISHED DATA Perfusion of IgG ProducingChinese Hamster Ovary Cells by AlternatingTangential Flow Filter at Very High Cell DensityVeronique Chotteau, Ph.D., Principal Investigator,KTH - Royal Institute of Technology, Sweden2:00Advances in Single-UseSystems for Fluid Storageand TransferChris Shields, Marketing Manager,Single Use Systems, Saint-GobainLife ScienceEfficient and IntelligentProcess Control forAnimal Cell CultureRichard Ferraro, Business LeaderWAVE Products Group, GE HealthcareCASE STUDY/UNPUBLISHED DATA Strategies to OvercomeBispecific Antibody Purification Challenges UsingNovel Mixed Mode ChromatographyKenneth Kang, Ph.D., Principal Scientist, Head ofPurification Team, BioProcess Sciences, ImClone Systems,A wholly-owned subsidiary of Eli Lilly and CompanyCASE STUDY/UNPUBLISHED DATA A Comparison ofProtein A and Mixed-Mode Chromatographyfor the Purification of Monoclonal AntibodiesJit Ray, Ph.D., Deputy Director, Protein Chemistry,Sanofi PasteurCASE STUDY/UNPUBLISHED DATA The Uses ofHIC and Multimodal Chromatography inthe Purification of Bioconjugate WhoseComponents are Expressed in E.coli and CHOShuang Chen, Ph.D., Senior Scientist, PurificationProcess Development, Pfizer Inc.Concurrent Technology WorkshopsImpact of DisposableTechnology on theBiomanufacturing LandscapeRichard M. Eglen, Ph.D., VicePresident & General Manager,Corning Life Sciences2:30 Networking Luncheon in Poster and Exhibit HallChallenges and Exciting Solutions toBioprocessing Operations for the Manufacturingof Therapeutic Protein CandidatesTimothy Lee, Ph.D., Senior Consultant,Latham Biopharm GrouprCASE STUDY/UNPUBLISHED DATA Development ofStable Vaccine Formulation in Reference toInfluenza HemagglutininIndresh Srivastava, Ph.D., Vice President, Product Realization,and Senior Project Manager, Protein Sciences Corp.Development of Protein Capsular MatrixVaccine (PCMV) TechnologyKevin P. Killeen, Ph.D., Chief Scientific Officer,Matriavax Research and Development Corp.Rational Approach toBiosafety around theMammalian BioreactorChase Duclos-Orsello, Ph.D.,EMD MilliporeTBA12Reserve Your Seat Today! Call (800) 390-4078 or E-mail reg@ibcusa.com

Wednesday, September 18, 2013 • Main ConferenceFormulation and Delivery Analytical and Quality Manufacturing Strategy7:30 Coffee7:30 Technology Workshop with Light Continental BreakfastImplementing Disposable Chromatography: Technology Fit in Downstream Purification Fletcher L. Malcolm, Associate Director, Product Management & Marketing, Repligen CorporationSponsored by:8:00Chairman’s RemarksDean Pettit, Ph.D., Executive Director, Process and Product Development, Amgen, Inc.Product Attribute Control (PAC): A Future Vision for Protein Process Development and Manufacturing8:15 UNPUBLISHED DATA Determining the Attributes of Aggregated Biotherapeutics and their Potential Biological ConsequencesMarisa Joubert, Ph.D., Senior Scientist, Product Attribute, Sciences, Amgen, Inc.8:45 Connecting Product Attributes with Process StepsBrian Collins, Ph.D., Director, Protein Sciences, Momenta Pharmaceuticals9:15 CHOGenome.org - Infrastructure to Support the Next Generation of Development in BiopharmaceuticalsKelvin Lee, Ph.D., Gore Professor of Chemical & Biomolecular Engineering and Director, Delaware Biotechnology Institute, University of Delaware9:45Networking Refreshment Break in Poster and Exhibit Hall Sponsored by:Strategies for Achieving Stabilityfor High-Protein ConcentrationFormulations10:30 CASE STUDY/UNPUBLISHED DATA Ultrafiltration ProcessDevelopment for High Protein Concentration (>190g/L) Formulations to Minimize Protein AggregationBhut V. Bharat, Ph.D., Engineer I, Biologics ProcessDevelopment - Downstream, Bristol-Myers Squibb11:00 UNPUBLISHED DATA Developing Predictive Toolsfor Achieving Stable and High-ProteinConcentration FormulationsJohn Tsavalas, Research Assistant Professor, MaterialsScience Program, University of New Hampshire11:30 CASE STUDY/UNPUBLISHED DATA Using Viscosity asa Sensitive Probe of the Stability of ProteinTherapeutic FormulationsJai Pathak, Ph.D., Scientist, Drug Delivery and DeviceGroup, MedImmune12:00Advances in Single-UseSystems for Fluid Storageand TransferChris Shields, MarketingManager, Single Use Systems,Saint-Gobain Life ScienceEfficient and IntelligentProcess Control for AnimalCell CultureRichard Ferraro, Business LeaderWAVE Products Group, GE HealthcareProduct Attribute Control (PAC):A Future Vision for Protein ProcessDevelopment and ManufacturingProcess Control and Raw MaterialsMaureen Lanan, Ph.D., Principal Scientist AnalyticalDevelopment, Biogen Idec, Inc.(10:50) PAT and Product Attribute ControlRobert Bailey, Ph.D., Principal Scientist,Drug Substance Development, Analytical Sciences,Amgen, Inc.(11:10) Interactive Panel and Audience DiscussionModerators:Timothy Charlebois, Ph.D., Vice President, Technologyand Innovation Strategy, Pfizer, Inc.Rohin Mhatre, Ph.D., Vice President, BioPharmaDevelopment, Biogen IdecConcurrent Technology WorkshopsImpact of DisposableTechnology on theBiomanufacturing LandscapeRichard M. Eglen, Ph.D., VicePresident & General Manager,Corning Life Sciences12:30 Networking Luncheon in Poster and Exhibit HallFlexible Facilities, Multi-productManufacturing and Single-UseImplementation: PracticalExperiences and Lessons LearnedSponsored by:Session Chairman: Jerold Martin, Senior Vice President,Global Scientific Affairs, Pall Life SciencesCASE STUDY Facility of the Future – Single UseFacility, A Case Study from Biogen IdecChien Lin, Senior Manager, Process Engineering, GlobalProject Engineering, Biogen Idec, Inc.CASE STUDY Multiproduct Facility Operations- Technologies, Efficiencies and ContinuousImprovement CultureBob Munday, Vice President, Technical Operations,CMC Icos Biologics, Inc.Single-use Single-pass TFF: An Approach toDiafiltrationJon Petrone, Vice President, Americas Biopharm, SLSGlobal Technical Support, Pall Life SciencesRational Approach toBiosafety around theMammalian BioreactorChase Duclos-Orsello, Ph.D.,EMD MilliporeTBAVisit www.IBCLifeSciences.com/BPI for Full Abstracts and Up-To-Date Information13

Wednesday, September 18, 2013 • Main ConferenceFormulation and Delivery Analytical and Quality Manufacturing Strategy1:45 Chairman’s RemarksTim Kelly, Ph.D., Vice President, BiopharmaceuticalDevelopment, KBI Biopharma, Inc.Analytical Strategies for SynchronizedFormulation and DeviceDevelopment2:00 CASE STUDY/UNPUBLISHED DATA Formulation andDelivery Through Rational Approaches toDevelopabilty and ManufacturabilityBernhardt L. Trout, Professor, Department of ChemicalEngineering, Massachusetts Institute of Technology2:30 CASE STUDY/UNPUBLISHED DATA Strategies andChallenges in Formulation Developmentand Device Integration for BioproductsNagarajan Thyagarajapuram, Senior Research Scientist,Eli LillyChairwoman’s RemarksPauline M. Rudd, Ph.D., NIBRT Research Professor ofGycobiology, Dublin-Oxford Glycobiology Laboratory,NIBRT, IrelandAdvanced Analytics andInnovative Technologies(1:50) How Analytics are Keeping Pacewith Process Development - InnovativeTechnologies to Achieve Rapid and RobustProcess Development and IntegratingProcess and Analytical KnowledgeKenji Furuya, Ph.D., Head of Analytical Science,Boehringer Ingelheim(2:20) Development and Application of aCharge Heterogeneity Method Based onCZE for a Complex (non-mAb) ProteinTherapeuticDan Roseman, Ph.D., Senior Scientist, Shire HGTChairman’s RemarksJerold Martin, Senior Vice President, Global ScientificAffairs, Pall Life SciencesFlexible Facilities, Multi-productManufacturing and Single-UseImplementation: PracticalExperiences and Lessons Learned(continued)Sponsored by:UNPUBLISHED DATA Biosimilars Opportunitiesand Challenges in an EmergingMarket: The Role of Flexible, LocalizedBiomanufacturing FacilitiesAbdullah Baaj, M.D., CEO, Boston OncologyManaging Multi-Use Pilot FacilitiesChrysta Mayhew, Operational Manager, Clinical BulkManufacturing , BioProcess Research and Development,Sanofi Pasteur, Canada3:00 Rapid Reformulation to Improve ParticleFormation and StabilityVickie Dowling, Associate Director, BiopharmaceuticalDevelopment, KBI Biopharma3:30(2:50) Advanced Glycan Analysis in Researchand Production of BiologicsPauline M. Rudd, Ph.D., NIBRT Research Professor ofGycobiology, Dublin-Oxford Glycobiology Laboratory,NIBRT, IrelandNetworking Refreshment Break in Poster and Exhibit Hall Sponsored by:4:15 BioProcess International Magazine’s Best Poster Award Announced Brian Caine, Publisher, BioProcess InternationalKeynote Presentations4:20 Chairwoman’s RemarksJoanne T. Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies4:25 Panel Discussion: What Defines a ClosedSystem and How to Implement One forGreater Manufacturing Flexibility?Moderator: Jerold Martin, Senior Vice President, GlobalScientific Affairs, Pall Life SciencesPanelists: Session Speakers andPranhitha Reddy, Ph.D., Director, Process Development,Seattle GeneticsBob Munday, Vice President, Technical Operations,CMC Icos Biologics, Inc.Chien Lin, Senior Manager, Process Engineering, GlobalProject Engineering, Biogen Idec, Inc.5:05 Biologics Manufacturing in a Rapidly Changing EnvironmentPeter Moesta, Ph.D., Senior Vice President, Biologics Manufacturing & Process Development, Bristol-Myers Squibb Co.5:45Eliminating Interfaces: Process Development Lessons from Aggressive Platform DevelopmentLars Pampel, Ph.D., Group Head, Early Phase Process Development, Novartis Pharma AG, SwitzerlandMixed-Mode Mixer Reception in Poster and Exhibit Hall Co-Sponsored by:Interactive Session • Wednesday, September 18, 2013 • 8:00 am – 12:00 pmFeatured Session with Interactive Discussion and Audience ParticipationProduct Attribute Control (PAC): A Future Vision for Protein Process Development and ManufacturingThe development and manufacturing of biopharmaceuticals has historically been achallenging and expensive process over the lifecycle of the product. Typically, processesneed to be scaled up and improved as product requirements increase, potentially leadingto changes in product attributes and comparability risks that must be managed, withsignificant time and scientific effort required to address the issues and risks encounteredon each individual project. Given the immense complexity and molecular heterogeneity ofmany biopharmaceuticals, it has been very difficult to maintain an exact profile of productattributes, or to know which of these attributes are clinically relevant.Scientific and technological advances have suggested that the development andmanufacturing paradigm of the future could be freed from the constraints of the past, witha greater understanding of 1.) attribute criticality; 2.) the relationship of manufacturingprocess design/conditions to product attributes and 3.) the ability to assure reliable controlof product quality for patients. This session will highlight key examples of advances inthese areas, followed by an interactive discussion of the potential of these approaches tofundamentally transform process and product development for biopharmaceuticals.Session Organizers and Discussion Moderators:Dean Pettit, Ph.D., Executive Director, Process and Product Development, Amgen, Inc.Timothy Charlebois, Ph.D., Vice President, Technology and Innovation Strategy,Pfizer, Inc.Rohin Mhatre, Ph.D., Vice President, BioPharma Development, Biogen Idec, Inc.Visit www.IBCLifeSciences.com/BPI for Full Abstracts and Up-To-Date Information15

Thursday, September 19, 2013 • Main ConferenceFormulation and Delivery Analytical and Quality Manufacturing Strategy7:30 Coffee8:00 Chairman’s RemarksDanny K. Chou, Pharm.D., Ph.D., Senior ResearchScientist I, Gilead Sciences, Inc.Chairwoman’s RemarksMelissa Morandi, Vice President, Quality,Acceleron Pharma, Inc.Strategies for Achieving Stability forHigh-Protein ConcentrationQuality Risk Management andQuality Auditing8:15 TBA CASE STUDY/UNPUBLISHED DATA QualityRisk Assessment Strategies forBiopharmaceuticalsBen Locwin, Ph.D., Head of Training & Development,Quality Assurance, Lonza Biopharmaceuticals8:45 CASE STUDY/UNPUBLISHED DATA FormulationDevelopment Challenges with HighlyConcentrated Protein FormulationsFarooq Qureshi Ph.D., Pharmaceutical and AnalyticalResearch & Development, Hoffmann-La Roche Inc.9:15 Processing Challenges for HighConcentration FormulationsSteven J. Shire, Ph.D., Staff Scientist and Group Leader,Late Stage Pharmaceutical Development, Genentech, Inc.9:45 CASE STUDY/UNPUBLISHED DATA Effects ofMethionine Oxidation on Conformationaland Colloidal Stability of a Fusion Proteinand Their Role in AggregationDanny K. Chou, Pharm.D., Ph.D., Senior ResearchScientist I, Gilead Sciences, Inc.10:15Risk Management and Effective Planningfor Quality & Regulatory Success inIncreasingly Progressive MultiproductBiologics FacilitiesStephen Reich, Director, Quality Systems, Pfizer, Inc.Kristin Murray, Associate Director, Global CMCRegulatory Affairs, Pfizer, Inc.Disposables: Quality QuandarySara Thomas, Site Quality Director, GlaxoSmithKlineCASE STUDY Best Practices in Quality AuditingMelissa Morandi, Vice President, Quality,Acceleron Pharma, Inc.Networking Refreshment Break in Poster and Exhibit Hall Sponsored by:Chairman’s RemarksBrandon Pence, Director, Thermo Fisher ScientificSingle-Use Innovations in Criticaland High-value ApplicationsSponsored by:Development, Qualification and Applicationof Single-Use Technologies for BioProcessingMichael Goodwin, Associate Director, DevelopmentEngineering, Thermo Fisher ScientificCASE STUDY/UNPUBLISHED DATA Investigation andReduction of Performance Variability inSingle-use Cell Culture BioreactorsRajesh Krishnan, Ph.D., Associate Director, Cell Lineand Upstream Process Development, Gilead SciencesEmerging Applications and LessonsLearned from Single-Use Technologies:A CMO PerspectiveMichiel Ultee, Ph.D., Chief Scientific Officer,Laureate Biopharmaceutical Services, Inc.Implementing Single-Use as a Strategic &Manufacturing PhilosophyMichael E. Jenkins, Ph.D., General Manager, Madison,Catalent Pharma SolutionsBiosimilar Formulation andQbD Considerations forBiologic DevelopmentQuality Risk Management andQuality Auditing (continued)Single-Use Innovations in Criticaland High-value Applications (continued)Sponsored by:11:00 UNPUBLISHED DATA How Quality by Design (QbD)and Process Analytical Technology (PAT) CanImprove Structure-Activity Relationship (SAR)Evaluation and Its Relevance to ComparabilityProtocols and BiosimilarsRobert L. Zeid, Principal Consultant, TLI Development11:30 QbD Impact on Formulation and DeviceDevelopment and Manufacturing, and onDelivery of Drugs to PatientsSheryl Martin-Moe, Ph.D., Vice President,Enterprise Catalyst Group, Former Director,Late Stage Pharmaceutical and Processing, Genentech12:003M Matched ComponentSolution for Optimal CellCulture Clarification utilizingEmphaze AEX Hybrid PurifierJonathan F. Hester, Ph.D., TechnicalSpecialist, 3M Purification IncCASE STUDY/UNPUBLISHED DATA Quality by Design:Gaining More Knowledge FasterClinton Weber, Associate Director of BioProcessSciences, CMC BiologicsCASE STUDY Risk Management andRaw MaterialsMartin Carvalho, QA Compliance Manager,Acceleron PharmaceuticalsConcurrent Technology Workshopsambr: An Advanced Tool forAutomated Optimization of CellCulture for BiotherapeuticsBarney Zoro, Product Manager,TAP Biosystems, United KingdomNovel Protein A AffinityChromatography Resin forEfficient mAb PurificationApplicationsNanying Bian, Ph.D., EMD Millipore12:30 Networking Luncheon and Last Chance for Exhibit and Poster Viewing in Poster and Exhibit HallUNPUBLISHED DATA Implementing FullyDisposable Upstream BioprocessingSystems for GMP Clinical SupplyYing Zhu, Ph.D., Lab Head, Cell Culture Technology,Boehringer Ingelheim Fremont, Inc.Panel Discussion: What’s Next for SingleUse?: Emerging Applications in ProcessDevelopment and ManufacturingModerator:Brandon Pence, Director, Thermo Fisher ScientificPanelists: Session SpeakersViral Risk Mitigation Strategiesfor Cell Culture Raw Materials andManufacturing ProcessesKathryn Martin Remington, Ph.D.,Principal Scientist, Development Services,Clearance, BioRelianceAndrew D. Christie, Ph.D., PrincipalScientist, Cell Sciences and Development,SAFCVisit www.IBCLifeSciences.com/BPI for Full Abstracts and Up-To-Date Information17

Interactive Session3:45pm -5:45 pmInteractive Town Hall Forumwith Audience ParticipationHarmonization of Single UseSystems: Extractables & Leachablesand Other InitiativesA Meeting of the Minds from BPSA, ASTM,ASME BPE, PDA, BPOG and ISPE• What is the purpose of guidances andstandards for single-use systems?• How best to achieve this purpose: What arethe benefits and pit falls of such guidancesand standards?• Who has scope of responsibility and who arethe stakeholders regarding harmonization ofsingle use materials and systems• In what areas are the stakeholders aligned intheir thinking and where are the gaps?• Should there be one international standardor multiple international/regional standardsthat are harmonized?• Can we learn anything from other industries?(medical devices or seminconductors)In cooperation with:NEW! Register 3 andthe 4th goes FREE!It’s a fact – attendees walk awaywith the most value when theyexperience it with a peer – thereis just too much informationavailable for one person tocapture it all. As a result, we arepleased to offer the most costeffective pricing possible in orderto accommodate and promotecompany collaboration. For moreinformation call our group salesadvocate at 646-895-7445.Thursday, September 19, 2013 • Main ConferenceCell Culture1:40 Chairwoman’s RemarksPranhitha Reddy, Ph.D., Director, Process Development,Seattle GeneticsControl of Process andProduct Quality1:45 CASE STUDY/UNPUBLISHED DATA Application ofMultivariate Predictive Monitoring andControl of Cell Culture ProcessesTony Wang, M.S., Senior Engineer, DigitalDevelopment, Amgen Inc.2:15 CASE STUDY/UNPUBLISHED DATA Developing anAdaptive Manufacturing Process to EnsureProduct Quality using QbD and PATJose M. Gomes, Principal Scientist, Culture ProcessDevelopment, Pfizer Inc.Recovery & PurificationChairwoman’s RemarksChristine Gebski, M.S., Head, POROS Business Unit andGlobal Applications, Life TechnologiesExpanding the Tool Box –Novel Purification Methods andSingle-Use ApplicationsSponsored by:UNPUBLISHED DATA PEGylating Protein AMedia: Increasing Selectivity for MAbs byDecreasing Non-Specific BindingTodd M. Przybycien, Ph.D., Professor of ChemicalEngineering and Biomedical Engineering, Department ofChemical Engineering, Carnegie Mellon UniversityCaptureSelect Ligand Technology;A Unique Platform for Purification ofAntibodies, Antibody Fragments andTherapeutic ProteinsBruce Dawson, Vice President, Commercial/BusinessDevelopment, Bioproduction, Life Technologies2:45 UNPUBLISHED DATA Use of Flow Cytometryfor Prediction and/or Conformationof Instability in Cell Lines ExpressingRecombinant AntibodiesSusanne Corisdeo, M.S., Scientist, Biotechnology CenterUNPUBLISHED DATA Expanding the PurificationToolbox Using Single-Pass TangentialFlow FiltrationMatthew Westoby, Senior Engineer II, TechnicalDevelopment, Biogen Idecof Excellence, Janssen Research & Development, LLC3:15 Networking Refreshment BreakModels for Perfusion andFed Batch Processes3:45 CASE STUDY/UNPUBLISHED DATA MathematicalModeling of Perfusion FermentationProcesses and Impacts on Manufacturingand DownstreamRick Johnston, Ph.D., Principal, Bioproduction Group,Executive Director, CELDI Center at University ofCalifornia at Berkeley4:15 CASE STUDY/UNPUBLISHED DATA Development ofQualified Scale-Down Models forFed-Batch ProcessesSara Gall, M.S., Senior Associate Scientist, Amgen Inc.4:45 CASE STUDY/UNPUBLISHED DATA From Bioreactorsto Shake Flasks to Mini-Bioreactors:Minimizing the Scale in Fed BatchMammalian Cell CultureVijay Janakiraman, Ph.D., Senior Engineer II, CellCulture Development, Biogen IdecAdvances in Analytics & Models toAid Downstream Process DevelopmentAutomation of Analytical Assays to SupportHigh Throughput in Process Developmentof BiologicsXiaodun (Susan) Mou, Ph.D., Associate PrincipalScientist, Merck & Co., Inc.CASE STUDY/UNPUBLISHED DATA High-ThroughputSmall-Scale Ion Exchange Protein PurificationLam Raga Anggara Markely, Ph.D., Scientist I, CellCulture Development, High-Throughput AnalyticalGroup, Biogen IdecCASE STUDY/UNPUBLISHED DATA Characterizationof Impurity Isoforms Using AdvancedAnalytical Technologies to Improve CriticalChromatography Step for RecombinantProtein TherapeuticsMelanie Lin, Ph.D., Senior Scientist, Shire Pharmaceuticals5:15 Close of BioProcess International Conference & Exhibition 2013Join theConversationJoin IBC Life Sciences’ 8,000 member LinkedIn group: Bioprocessing Professionals.With more than 8,000 members, you have the opportunity to post questions and findnetworking contacts. Get involved today.Follow @IBCBioProcess on Twitter for special offers and news about the event.Use the #bpiconf hashtag to discuss the event. Stay up to date with IBC Life Sciencesand follow us at @IBCBioProcess and @ibcusa.“Like” IBC Life Sciences on Facebook andyou will stay up to date with newly addedspeakers, conference discounts and more.18Reserve Your Seat Today! Call (800) 390-4078 or E-mail reg@ibcusa.com

Thursday, September 19, 2013 • Main ConferenceFormulation and Delivery Analytical and Quality Manufacturing Strategy1:40 Chairwoman’s RemarksAndrea Leone-Bay, Ph.D., Vice President of PharmaceuticalResearch and Development, MannKindChairman’s RemarksJose M. Gomes, Principal Scientist, Culture ProcessDevelopment, Pfizer Inc.Chairman’s RemarksJonathan Blackie, Senior Director of Manufacturing,BioMarinBiosimilar Formulation andQbD Consideration forBiologic Development (continued)Control of Process andProduct QualityManufacturing Technologies toImprove Efficiency and Control1:45 CASE STUDY/UNPUBLISHED DATA Drug ProductDevelopment Strategies for BiosimilarsKrishnan Sampath, Ph.D., Associate Director,Formulation and Drug Product Process Development,Global Biologics R&D, HospiraLocalized and TargetedDelivery Strategies2:15 CASE STUDY/UNPUBLISHED DATA Dry PowderFormulations for the Inhalation of BiologicsAndrea Leone-Bay, Ph.D., Vice President ofPharmaceutical Research and Development, MannKindCASE STUDY/UNPUBLISHED DATA Application ofMultivariate Predictive Monitoring andControl of Cell Culture ProcessesTony Wang, M.S., Senior Engineer, DigitalDevelopment, Amgen Inc.CASE STUDY/UNPUBLISHED DATA Developing anAdaptive Manufacturing Process to EnsureProduct Quality using QbD and PATJose M. Gomes, Principal Scientist, Culture ProcessDevelopment, Pfizer Inc.High Efficiency and Well Defined ProcessDevelopment Approach – Implementationof DMAIC (Define, Measure, Analyze,Improve, and Control) Methodologyand Statistical Analysis for ProcessImprovement and OptimizationTsu-Shun Lee, Ph.D., Senior Manager, BiologicsDevelopment Process Sciences, AllerganTransformative BiomanufacturingTechnologiesSeongkyu Yoon, Ph.D., Assistant Professor andDirector, Massachusetts BioManufacturing Center,University of Massachusetts Lowell2:45 UNPUBLISHED DATA Formulation Considerationsfor Microneedle Delivery SystemsPeter R. Johnson, Research Specialist - MTS Technologyand Product Development, 3M Drug Delivery SystemsUNPUBLISHED DATA Use of Flow Cytometryfor Prediction and/or Conformationof Instability in Cell Lines ExpressingRecombinant AntibodiesSusanne Corisdeo, M.S., Scientist, Biotechnology Centerof Excellence, Janssen Research & Development, LLC3:15 Networking Refreshment BreakLocalized and TargetedDelivery Strategies (continued)3:45 UNPUBLISHED DATA General Strategies forContainer Closure and Injection DevicesXinghang Ma, Ph.D., Head of Formulation,Freeze-drying, and Drug Delivery, Global BiologicalDevelopment, Bayer HealthCare LLC.4:15 CASE STUDY/UNPUBLISHED DATA Spray-driedPowders of Anti-IgE Monoclonal Antibodies(mAb) for InhalationSajeevi Gunasekera, Senior Scientist,Novartis Pharmaceuticals Corporation4:45 UNPUBLISHED DATA Innovations inLarge-Volume Injections for Biologicsand Protein TherapeuticsJennifer Laurence, Ph.D., Professor,University of KansasAdvances in Analytics &Models to Aid DownstreamProcess DevelopmentAutomation of Analytical Assays to SupportHigh Throughput in Process Developmentof BiologicsXiaodun (Susan) Mou, Ph.D., Associate PrincipalScientist, Merck & Co., Inc.CASE STUDY/UNPUBLISHED DATA High-ThroughputSmall-Scale Ion Exchange Protein PurificationLam Raga A. Markely, Ph.D., Scientist I, Cell CultureDevelopment Department, High-Throughput AnalyticalGroup, Biogen IdecCASE STUDY/UNPUBLISHED DATA Characterizationof Impurity Isoforms Using AdvancedAnalytical Technologies to Improve CriticalChromatography Step for RecombinantProtein TherapeuticsMelanie Lin, Ph.D., Senior Scientist, Shire Pharmaceuticals5:15 Close of BioProcess International Conference & Exhibition 2013UNPUBLISHED DATA Perfusion Technology/Continuous Processing: Lessons Learnedand Potential Applications to mAbs andOther MoleculesJonathan Blackie, Senior Director of Manufacturing,BioMarinA Town Hall Forum: Harmonizationof Single Use Systems: Extractables& Leachables and Other InitiativesStatus Updates from BPSA, ASTM, ISPE, PDA, BPOGand ASME BPE on Current Initiatives3:45 ASTM Perspective: Robert Steininger, Senior VicePresident, Manufacturing, Acceleron Pharmaceuticals, Inc.3:55 PDA Perspective: Bob Repetto, Senior Director, ExternalAffairs, Pfizer4:05 ISPE Perspective: Pietro Perrone, Chair of DisposablesCommunity of Practice – ISPE and Mobius Single-UseSystems Engineer, EMD Millipore4:15 ASME BPE Perspective: Jay Ankers, Director ofTechnology, M+W Group4:25 BPOG Perspective: David Pollard, Ph.D., ExecutiveDirector, Merck & Co., Inc.4:35 BPSA Perspective: Jerold Martin, Senior Vice President,Global Scientific Affairs, Pall Life Sciences4:45 Interactive Town Hall Discussion with Audience ParticipationDiscussion Moderator: James Dean Vogel, Founder andDirector, The BioProcess InstitutePanelists: Speakers list above, plus:Additional ASME BPE Perspective: Michael Zumbrum,President, Maztech, Inc.5:45 Close of Town Hall ForumNow Available: Exhibit Hall & Keynote PassesThe BPI Exhibition provides you more than 17 hours of networking opportunities in the exhibit hall, featuringthe most extensive array of technology and service providers showcasing 150 exhibitors and so much more!For complete details on the exhibit hall & keynote pass visit: www.IBCLifeSciences.com/BPIQualification: Exhibit Hall & Keynote pass purchases are only made available for qualified researchers, scientists, engineers, quality professionals andexecutives from biotechnology, biopharmaceutical or pharmaceutical organizations. All registrations will be reviewed and IBC reserves the right to provide thisaccess only to those who do meet the qualified criteria. Those who do not qualify for this option must register for one of the main conference selections thatprovides access to the conference and exhibit hall. If your company is exhibiting, individuals must register through their company for access to the exhibit hall.Visit www.IBCLifeSciences.com/BPI for Full Abstracts and Up-To-Date Information19

Connecting YOU to Education, Industry and InnovationMix n’ Mingle and Find New Ideas from Your PeersYour next major breakthrough, career opportunity and big idea won’tcome from sitting in your office/lab. Step away for few days and into aworld of new possibilities at BPI 2013! Let us connect you to inspiration,partnerships, education and the technologies you need to be the best!Attendee TitlesScientist/Researcher18%Specialist/Associate13%Director19%Engineer8%We Take the “Work” Out of NetworkingPresident/C Level/VP12%Other6%Top Attendee DepartmentsAnalytical Development/SciencesBioprocess R&DBusiness DevelopmentCell Line Development &EngineeringDownstream ProcessingFacilities ManagementFormulation/DeliveryManufacturing Science &TechnologyManager/Head/Supervisor24%Process DevelopmentProcess EngineeringProtein SciencesQuality Assurance/Quality ControlRecovery/PurificationRegulatory Compliance/AffairsStrategic PlanningSupply ChainUpstream ProcessingVaccines Development/ProductionTake a break from all the sessions and enjoy any or all of thesenetworking opportunities we have built into the agenda for you!Tuesday, September 17, 2013Exhibit & Poster Hall HoursMorning CoffeeRefreshment BreakLuncheonGrand Opening Exhibit HallWine & Cheese Reception3:15 pm – 7:15 pm7:00 am – 8:00 am9:45 am – 10:15 am12:15 pm – 1:30 pm3:15 pm – 4:00 pm6:00 pm – 7:15 pmWednesday, September 18, 2013Exhibit & Poster Hall HoursMorning CoffeeRefreshment BreakLuncheonRefreshment BreakWine & Cheese Reception9:45 am – 7:00 pm7:30 am – 8:00 am9:45 am – 10:30 am12:30 pm – 1:45 pm3:30 pm – 4:15 pm5:45 pm – 7:00 pmThursday, September 19, 2013Exhibit & Poster Hall HoursMorning CoffeeRefreshment BreakLuncheonRefreshment Break10:15 am – 1:40 pm7:30 am – 8:00 am10:15 am – 11:00 am12:30 pm – 1:40 pm3:15 pm – 3:45 pmLet’s Get SocialSpeed Networking: Come prepared to talk fast, talk best practices andmake new business connections during our exhibit hall speed networkingsession – back by popular demand.BPI Morning Run: Start your day off with a breath of fresh air! Join inon a morning run thru the historic streets of Boston and along the banksof the river Charles. Bring your running shoes and meet at the SheratonHotel registration desk Wednesday, 9/18 at 6:15 am.22Reserve Your Seat Today! Call (800) 390-4078 or E-mail reg@ibcusa.com