THE Meeting Place for the BioprocessingIndustry to Learn New Approaches toBiopharmaceutical Manufacturing<strong>Conference</strong>: <strong>October</strong> 1-4, <strong>2007</strong>Exhibition: <strong>October</strong> 1-3, <strong>2007</strong>Hynes Convention Center, Boston, MARecent changes in the biopharmaceutical manufacturing industry includeregulatory evolution, dramatic improvements in upstream yields and neweconomic pressures on biotech drugs. The design space concept opens thedoor to greater regulatory flexibility and reduced validation requirements.Upstream advances impact downstream processes. Regulatory changes affecteveryone. That’s why it’s more important than ever to be on top of all thesedevelopments to make the most of these changes at your company.BioProcess International <strong>Conference</strong> and Exhibition is the one place whereyou can get the information you need, benchmark your efforts againstpeers, get frank future forecasts in small group settings as well as visionarykeynotes – all in a program developed by the industry, for the industry.BPI is the most well-attended, highly-respected meeting focused just onbiopharmaceutial industry manufacturing challenges.This year <strong>IBC</strong> and our distinguished advisory committees have developeda program with a theme of evolving regulatory initiatives and processcapabilities so you can streamline process development and capacityplanning. Presenters will show you how they have utilized new typesof facilities, technologies and licensure avenues to quickly achievemanufacturing friendly processes in compliance with internationalregulatory guidelines.Hear experiences from theindustry leaders as well asmany small- to mid-sizedcompanies to find solutionsthat will work in yourspecific situation.EYE ON THEFUTUREFeatured Presentations:Future of Cell Line and Process DevelopmentBarry C. Buckland, Ph.D., Research Vice President BioProcess R&D,Merck Research LaboratoriesLessons Learned and Not – Future Directions in ChromatographyJohn Curling, Chief Executive Officer, John Curling Consulting AB, SwedenPoint/Counterpoint AudienceInteractive Panel Discussion:The Future of Downstream Processing:How Best to Handle Higher BioreactorOutputs and Greater Product Demands4 <strong>Conference</strong> Tracks for CustomizedInformation Gathering:• Production & Economics of Biopharmaceuticals• Scaling Up from Bench through Commercialization• Cell Culture & Upstream Processing• Recovery & PurificationNew Sessions for <strong>2007</strong>:• Scale Down Models, Process Characterization and Validation• Early Stage Process Development – Getting to the Clinic Faster• Next Generation / Disruptive Purification Technologies• Overcoming the Challenges of the Ton Scale ProcessNew! In-Depth Pre-<strong>Conference</strong> Workshops:• Workshop A: Analytical Methods for Process Development, ProductCharacterization and Formulation Screening• Workshop B: Transient Expression SystemsAudience Interactive Panel Debates on:• Analytical Methods• Impact of Regulatory and Industry Trends on Process Development andManufacturing strategies• Scale Down Models, Process Characterization and ValidationSpecial Attractions:• Site Tours at Applied Biosystems, Biogen Idec and GE Healthcare• Exhibit Hall Packed with 120 Suppliers and 1300 Attendees• Collaborative Learning Experiences in Small Working Groups• Exhibit Hall Networking Receptions - The Place to Mix & Mingle!New! Co-Located Formulation Strategies for ProteinTherapeutics <strong>Conference</strong>:• Practical case studies and survey presentations to help accelerate andimprove formulation development• Joint industry/supplier panel on prefilled syringes• Interactive Scientific Exchange sessions in which delegates work through aproblem-solving exercise to resolve aggregation problems in formulatinghigh concentration antibody products• Purchase the Dual <strong>Conference</strong> Pass and gain access to conference sessionsand materialsNew! Professional Development Courses:• Technology Transfer of Biopharmaceuticals to Ensure a SuccessfulTransfer and Implementation of Processes• Introduction to Biopharmaceutical Manufacturing to Gain OverallPerspective on Processes and Operations, Understanding ofTechnologies, Testing Methods and Process Validation• Design of Experiments and How to Use Designed Experimentsto Perform Efficient Drug Development in BiopharmaceuticalManufacturing Processes“Off-the-Record” Break-Out Discussions:• Strategies for Small Companies Managing Late Stage Development• Modeling Up and Scaling Down: Use of Model Systems in ValidationAssurance*• Quality by Design: Aspiration and Application*• The Impact of Evolving Process Capabilities and Adaptation on Facilities• Making the Connection: How to Hire, Train, and Retain Talent• Building the Biomanufacturing Education and Training Infrastructure* Attendance is limitedNo other event provides you with a better return on your investment with new insights, new collaborators, new approaches – and new ways to help your candidate get to marketfaster, with more competitive COG, assured potency and patient safety.To maximize your return even further, see the vast majority of vendors in this space under one roof with one of the largest exhibitions of suppliers to biopharmaceutical manufacturersin the world.Reserve your place today at the industry event of the year and take advantage of early bird and team discounts.
Begin with strategic planning and continue through state-of-the-art technologies for a comprehensive conference programProduction & Economics of1 BiopharmaceuticalsLearn the latest strategies for capacity planning used by small and largecompanies, including outsourcing, building, offshoring, and optimizingpresent facilities, for a variety of molecule types. Hear about implementationof operational excellence, six sigma and lean manufacturing to mitigatecontamination risk at Genentech’s Vacaville plant, to improve operationaleffectiveness at Human Genome <strong>Sciences</strong> and to enable a high-throughputproject portfolio at Wyeth BioPharma. Understand how to evaluatepotential cost savings by using single-use or disposable technologies,and how biosimilars and follow-on biologics will affect the future ofbiopharmaceutical manufacturing.2Scaling Up from Bench throughCommercializationHear process development strategies from Amgen and Genentech includinghow these industry leaders plan production networks and design facilities, fromclinical through commercial manufacturing. Biogen Idec presents case study onchallenges of process development for a PEGylated protein and how they wereovercome in R&D, Manufacturing/Facilities and Quality departments. Learnabout Pfizer’s and Lilly’s recent experience with design space. Gain updateson PAT from a European regulator, and learn about industry experience withcomparability, post-licensure changes and ICH Q8, 9, and 10 from Genentech.Attend an in-depth session on scale-down models including case studies of thosethat were—and were not—predictive of large scale production and understandhow to use them in process validation and characterization with case studiesfrom VIRxSYS, Protherics, Biogen Idec and PDL BioPharma.Production and Economics TrackGeorge Avgerinos, Ph.D., Director, Technical Operations,Global Pharmaceutical Operations, Abbott Bioresearch CenterWolfgang Berthold, Ph.D., Chief Technical Officer, Biogen IdecFrank Jackson, Vice President, Genentech Vacaville Product OperationsHoward L. Levine, Ph.D., President, BioProcess TechnologyConsultants, Inc.Duncan Low, Ph.D., Scientific Executive Director, Process Development,Amgen, Inc.Abhinav Shukla, Ph.D., Associate Director Bioprocess Engineering,Bristol-Myers SquibbScaling Up from Bench throughCommercialization TrackJeffrey C. Baker, Ph.D., Senior Research Advisor, Six Sigma Black Belt,Manufacturing <strong>Sciences</strong> and Technology, Eli Lilly and Co.Alex Fotopoulos, Director of Engineering, Biogen IdecRichard Francis, Director of Process Development and Technical Support,Protherics, United KingdomRoger A. Hart, Ph.D., Scientific Director, Process Development, AmgenManinder Hora, Ph.D., Vice President, Process Development, PDLBioPharma, Inc.Dr. Günter Jagschies, Director R&D, Customer Applications,GE Healthcare Bio-<strong>Sciences</strong>, SwedenTom Ransohoff, Senior Consultant, BioProcess Technology Consultants, Inc.Frank J. Riske, Ph.D., Director, Purification Development, GenzymeCorporation3CellSpecial Thanks to the Scientific Advisory CommitteesCulture & Upstream ProcessingLearn how companies are accelerating development of high producing celllines while improving product quality through the successful combinationof proven approaches with a wide range of novel technologies. Case studiesfrom Avecia, Boehringer Ingelheim, Centocor, Genentech, Lonza Biologics,US Army and Wyeth will cover the latest breakthroughs during early stagedevelopment that will help dramatically decrease the time to clinic. Amgen willlead a discussion on approaches to reduce lot-to-lot hydrolysate variability thatwill include perspectives from the main media suppliers. Gain valuable insightsfrom industry leaders who are leveraging data to improve process consistency,reliability and productivity to help you achieve total process optimization.4Recovery& PurificationDiscover how companies are optimizing processes and avoiding costlybottlenecks with state-of-the-art technologies to increase robustness to ensureproduct quality. Hear the latest developments with chromatographic and nonchromatographicmethods, ultrafiltration, automation, analytical technologies,data analysis and process control to improve process efficiency, economy andquality. Thought leaders will discuss evolving regulatory guidelines and theirimpact on process validation, characterization and viral clearance. Exclusivecase studies from industry leaders will demonstrate companies that haveachieved significant improvements with new stationary phases and monoliths inchromatography, platform technologies, disposables, automated analytical assays,to increase the yield and speed of recovery and purification.Cell Culture & Upstream Processing TrackMike Berry, Ph.D., Director of Cell Culture & Fermentation, Process <strong>Sciences</strong>,Nuvelo Inc.Timothy S. Charlebois, Ph.D., Director, Cell & Molecular <strong>Sciences</strong>, Wyeth BioPharmaLaurel Donahue-Hjelle, Ph.D., Director of Cell Line Development, InvitrogenCorporationKevin J. Kayser, Ph.D., R & D Manager, Cell Line Engineering, SAFC BiosciencesDennis M. Kraichely, Ph.D., Principal Research Scientist, Pharmaceutical Development,Centocor R&D, Inc.Jim Michaels, Ph.D., Director of Cell Culture and Fermentation, BioMarinPharmaceuticals, Inc.John Mott, Ph.D., Director, Bioprocess R&D, Cell Line Development, Pfizer GlobalBiologicsCharles Sardonini, Ph.D., Associate Director, Process Engineering/Development,Genzyme CorporationThomas Seewoester, Ph.D., Director, Process Development, AmgenJanani Swamy, Ph.D., Director, Cell Culture Operations and Technical Services,Genzyme CorporationRon Taticek, Ph.D., Associate Director, Fermentation MSAT, SSF BiochemicalManufacturing, Genentech, Inc.Recovery and Purification TrackJoanne Beck, Ph.D., Director of Biologics Manufacturing, Abbott Bioresearch CenterEdward Cole, Ph.D., Senior Vice President, Protein Development, GenzymeCorporationChris Dowd, Ph.D., Senior Engineer, Late Stage Purification, Genentech, Inc.Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius, GermanyBrian R. Hubbard, Ph.D., Scientific Executive Director, Process and Analytical <strong>Sciences</strong>,AmgenDavid W. Kahn, Ph.D., Director, Late-Stage Purification Development, Human Genome<strong>Sciences</strong>, Inc.Peter W. Wojciechowski, Director, Purification Technology, Global Biologics SupplyChain, Centocor