Cell Culture & Upstream Processing - IBC Life Sciences

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Monday, September 22, 2008 1:00 pm - 5:30 pm Workshop A: Technology Transfer Tuesday, September 23, 2008 Production & Economics of Biopharmaceuticals 8:00 am - 11:45 am 8:15 am - 8:45 am Strategic Planning for Biopharmaceuticals: Challenges for a Maturing Industry Keynote Presentation How to Motivate Staff to Implement Lean Manufacturing to Raise the Bottom Line Rob Bryant, MBA, Computer Sciences Corporation Conference-At-A-Glance Workshop B: Single Use Bioprocess Systems: Intensive Update Scaling Up from Bench through Commercialization Strategic Scale Up Decisions to Accelerate Process Development 11:45 am - 12:15 pm Technology Workshops sponsored by: Applied Biosystems, New Brunswick Scientific and Thermo Scientific 12:15 pm - 1:45 pm Networking Luncheon and Technology Workshop Sponsored by Invitrogen 1:45 pm - 3:30 pm 4:00 pm - 5:30 pm Production Planning for Cost-Efficient Manufacture Special Strategy Discussion Forum: Adopting New Technology: The Cost of Change Regulatory Updates: Tools for QbD (Quality by Design) Implementation Keynote Presentations The Challenges and Successes of Creating a Biologics Organization within Pfizer Rick Rutter, Ph.D., Vice President, Pharmaceutical Sciences, Biologics, Pfizer Inc Using Knowledge Management for Technical Collaboration across Generations Jeanne Holm, Chief Knowledge Architect, NASA Jet Propulsion laboratory 5:30 pm - 7:00 pm Exhibit Hall Opens with Cocktail Reception sponsored by SAFC Biosciences Wednesday, September 24, 2008 Production & Economics of Biopharmaceuticals 7:15 am - 7:45 am Technology Workshop Sponsored by Applied Biosystems 8:00 am - 12:00 pm Improving Competitiveness and Quality of Biopharmaceuticals Interactive Workshop and Discussion on Cell Line Stability and Heterogeneity Scaling Up from Bench through Commercialization Use of Scale Down Models throughout Product Lifecycle: Early to Late to Post Registration 12:00 pm - 12:30 pm Technology Workshops Sponsored by BIA Separations, ForteBio, GE Healthcare, and Thermo Scientific 12:30 pm - 2:00 pm Networking Luncheon in Exhibit/Poster Hall with Dedicated Poster Viewing 2:00 pm - 3:45 pm 4:15 pm - 5:45 pm Featured Presentations FDA Manufacturing Initiatives in Biotechnology Products Steven Kozlowski, Ph.D., Director, Office of Biotechnology Products, OPS, CDER, US FDA BioManufacturing 2008: Where Are We Now? Anthony Mire-Sluis, Ph.D., Executive Director, Global Product Quality and External Affairs, Amgen Inc. Post-Registration Process Changes: Considerations for Comparability Robert A. Baffi, Ph.D., Senior Vice President, Technical Operations, BioMarin Pharmaceutical Inc. Keynote Presentations Paths to Flexible Regulatory Notification of Large Molecule Life-Cycle Changes John K. Towns, Ph.D., Director, Global CMC Regulatory Affairs, Eli Lilly and Co. Biosimilars - Follow-on Biologics - Subsequent Entry Biologics – Biogenerics? Robert L. Garnick, Ph.D., Senior Vice President, Regulatory, Quality and Compliance, Genentech, Inc. 5:45 pm - 7:15 pm Networking Cocktail Reception in Exhibit/Poster Hall 6:30 pm - 7:00 pm Workshop C: Process Characterization and Monitoring During Development & Commercialization of Biopharmaceuticals Exhibit Hall Opens 5:30 pm - 7:00 pm Co-Located Formulation Strategies for Protein Therapeutics 8:20 am – 12:00 pm Pre-Conference Workshop: Developing Formulations for Prefilled Syringe-Based Products – From Early Development to Commercialization 1:30 pm - 2:15 pm Keynote Presentation Scientific Issues in Lifecycle Management: Optimizing Drug Products Based on Market Demands Anthony B. Barry, Ph.D., Principal Research Scientist, Drug Product Development, Wyeth BioPharma 2:15 pm – 3:45 pm Measuring and Predicting Protein Aggregation 4:15 pm – 5:45 pm Improving the Stability of Protein Therapeutics Exhibit Hall Hours: 9:45 am - 7:15 pm Co-Located Formulation Strategies for Protein Therapeutics Applying Quality by Design to Formulation and Process Development Advancing Formulation Development for High Concentration Protein Products 2:10 pm – 3:15 pm Advancing Formulation Development for High Concentration Protein Products (continued) 3:15 pm - 4:15 pm Special Presentation: The Role of Formulation Development in Biologics Patent Protection Timothy J. Shea, Jr., Director, Sterne, Kessler, Goldstein & Fox P.L.L.C. 4:15 pm - 5:45 pm Small Group Scientific Exchange Discussions Exhibit Hall Keynote Presentation: The Treacherous Path to Success in the Biotech Industry – Prof. Charles L. Cooney, Robert T. Haslam (1911) Professor, Department of Chemical Engineering, and Faculty Director, Deshpande Center of Technological Innovation, Massachusetts Institute of Technology Thursday, September 25, 2008 Production & Economics of Biopharmaceuticals Scaling Up from Bench through Commercialization Cell Culture & Upstream Processing Recovery & Purification Exhibit Hall Hours: 9:45 am - 4:00 pm Co-Located Formulation Strategies for Protein Therapeutics 7:15 am - 7:45 am Technology Workshop to be announced 8:15 am – 9:00 am Extended Long-Term Formulation Development Case Study 8:00 am - 12:00 pm Discussion and Workshop Sessions: • Lean Six Sigma in a Biotech Setting: Constraint or Enabler? • Standards for Disposables: What would End-Users Like to See? Advances in Cell Line Development & Clone Selection Overcoming Challenges of Large Scale Protein Production – Present and Future 12:00 pm - 12:30 pm Technology Workshops Sponsored by Novasep Process, Nysa Membrane Technologies, Novozymes and Sartorius Stedim North America Inc. 12:30 pm - 1:45 pm Networking Luncheon in Exhibit/Poster Hall 1:45 pm - 6:00 pm Discussion and Workshop Sessions: • Biosimilars: Where Are We Now? • Use of Scale-Down Models in Non-Conformance Resolution Proven Strategies for Process Development and Optimization Friday, September 26, 2008 Cell Culture & Upstream Processing Approaches for Successful Process Development and Optimization Recovery & Purification 9:00 am – 10:00 am Predictive Methods for Formulation Development 10:30 am – 12:00 pm Formulation Development for Lyophilized Products 2:00 pm – 3:00 pm Formulation Development for Lyophilized Products (continued) 3:00 pm – 5:00 pm Formulation Development for Novel Proteins 7:15 am - 7:45 pm Technology Workshop Sponsored by BD Biosciences – Advanced Bioprocessing 8:00 am - 11:45 am Media Development and Feed Strategies Product Quality and Regulatory Considerations 8:05 am - 8:45 am Keynote Presentation: Manufacturing Support – Lessons Learned and Trends for the Future Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corp. Overcoming the Direct Impact of High Titer Processes on Downstream Processing Interactive Panel Discussion: Challenges and Opportunities in Using BioSMB or other Multi-Column Approaches for Downstream Processing – Sponsored by Tarpon Biosystems Inc. 11:45 am - 12:15 pm Technology Workshops Sponsored by SAFC Biosciences, Millipore and Percivia LLC 12:15 pm - 1:30 pm Networking Luncheon and Technology Workshop Sponsored by Pall Life Sciences 1:30 pm - 3:15 pm Impact of Upstream Advances on Downstream Processing and Product Quality – Act Locally but Think Globally Protein A and Beyond 3:15 pm - 5:00 pm Overcoming Manufacturing Issues Improving Downstream Economies and Efficiencies Using Disposables in Chromatography Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event 3
"IBC’s BioProcess International Conferences are terrific. They are the benchmark for meetings of this type. The programs always include great speakers on current topics. I always either deepen my knowledge or learn something new when I attend the BPI conference.” – Maik W. Jornitz, Group Vice President, Marketing & Product Management, Filtration/Fermentation Technologies, Sartorius Stedim North America Inc. 1 Production & Economics of Biopharmaceuticals 3 Cell Culture & Upstream Processing Understand the potential impact of biosimilars through provocative presentations from Biocon, India and Boehringer Ingelheim, Germany. Learn how to achieve significant cost savings by implementing lean manufacturing in the keynote presentation from the high tech industry plus case study. Evaluate strategies for outsourcing and the economics of orphan drugs. Gain insight into pre-competitive research in logistics and manufacturing including long-range demand planning, plus hear strategies for production planning when demand is uncertain. Improve the competitiveness and quality of your product via reports on financial advantages of quality by design, analyses of disposables, and supply chain management. Advisory Board Joanne T. Beck, Ph.D., Plant Manager, Abbott Bioresearch Center Wolfgang Berthold, Ph.D., Chief Technical Officer, Biogen Idec William P. Botha, Director of Manufacturing, Baxter Healthcare Corporation Andrew Cockshott, Ph.D., Manager, Manufacturing Science and Technology, Eli Lilly and Co. Jon T. Conary, Ph.D., Senior Director, Manufacturing, Human Genome Sciences, Inc. Howard L. Levine, Ph.D., President, BioProcess Technology Consultants, Inc. Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen Inc. Rhona M. O’Leary, Ph.D., Director, BioProcess Development, Genentech, Inc. Learn how to accelerate your cell line development programs by applying technologies to help reduce development timelines and workflows while managing instability. Hear case studies on multi-faceted approaches to developing fast and efficient processes that control quality and improve manufacturability. Discover how to apply quality by design to balance product quality and robustness during cell line or process changes and use best practices to avoid pitfalls during the application of quality by design. Investigate tools and techniques to optimize your media design, development and feed strategies. Hear proven strategies to help you overcome the impact of upstream advances in process development. Advisory Board Timothy S. Charlebois, Ph.D., Senior Director, Drug Substance Development, Wyeth BioPharma Geoffrey Francis, Ph.D., Chief Scientist, Applied R&D, Novozyme BioPharma AV Ltd., Australia Laurel Donahue-Hjelle, Ph.D., Director of Cell Line Development, Invitrogen Corporation Kevin J. Kayser, Ph.D., R&D Manager, Cell Line Engineering, SAFC Biosciences Dennis M. Kraichely, Ph.D., Principal Research Scientist, Expression Technologies, Centocor, Inc. Suzanne Kuo, Ph.D., Senior Engineer, Late Stage Cell Culture Process Development, Genentech, Inc. John Mott, Ph.D., Director, Bioprocess R&D, Cell Line Development, Pfizer Global Biologics Charles Sardonini, Ph.D., Associate Director, Process Engineering/ Development, Genzyme Corporation Thomas Seewoester, Ph.D., Director, Process Development, Amgen Inc. Gary Welch, Director, Process Development, Abbott Bioresearch Center 2 Scaling Up from Bench through Commercialization 4 Recovery & Purification Accelerate your process development with platforms by leveraging informational sciences to compound and use process characterization data. The first session focuses on this concept with strategy from NASA’s Jet Propulsion Laboratory, plus industry case studies and an audience interactive panel discussion to ask your questions to the experts. Understand the latest tools for implementing quality by design. Hone your scale-down skills in the session on use of scale down models throughout the product lifecycle, with six detailed case studies. Advisory Board Jeffrey C. Baker, Ph.D., Senior Research Advisor, Manufacturing Sciences and Technology, Eli Lilly and Co. Roger A. Hart, Ph.D., Scientific Director, Process Development, Amgen Inc. Maninder Hora, Ph.D., Vice President, Process Development, PDL BioPharma, Inc. Günter Jagschies, Ph.D., Director R&D, Customer Applications, Protein Separation, GE Healthcare Bio-Sciences, Sweden Ellen L. McCormick, Director, BioProcess R&D, Pfizer Global Biologics, Pfizer Inc R. Andrew Ramelmeier, Ph.D., Vice President, Manufacturing and Process Development, BioMarin Pharmaceutical, Inc. Thomas C. Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc. David H. Reifsnyder, Ph.D., Principal Scientist, Process Development-Late Stage Purification, Genentech, Inc. Abhinav Shukla, Ph.D., Associate Director, Manufacturing Sciences, Bristol-Myers Squibb Company Hear how to develop new chromatographic and non-chromatographic methods to overcome the challenges of large scale protein production. Apply platform approaches for non-platform projects to efficiently develop purification processes for non-antibody drugs. Learn about the successful development of a 2-step purification process for monoclonal antibodies. Evaluate the economical and regulatory impact of sequential multi-column chromatography in downstream processing. Gain insights towards overcoming platform facility fit issues for high titer processes and reconfiguring a commercial biologics facility to a launch facility for new products. Benefit from case studies on the successful development and implementation of single-use processes in downstream processing. Advisory Board Edward Cole, Ph.D., Senior Vice President, Protein Development, Genzyme Corporation Chris Dowd, Ph.D., Senior Engineer, Late Stage Purification, Genentech, Inc. Adam Goldstein, M.S., Senior Manager, Oceanside Clinical Operations, Genentech, Inc. Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany Brian R. Hubbard, Ph.D., Scientific Executive Director, Process and Analytical Sciences, Amgen Inc. David W. Kahn, Ph.D., Director, Late-Stage Purification Development, Human Genome Sciences, Inc. Charles Schmelzer, Ph.D., Senior Scientist, Late Stage Purification, Genentech, Inc. Peter W. Wojciechowski, Director, Process and Analytical CMC, Johnson & Johnson Regenerative Therapeutics Paul Wu, Ph.D., Manager of Protein Isolation, Bayer Healthcare 4 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
Page 1 and 2: THE Meeting Place for the Bioproces
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Cell Culture & Upstream Processing - IBC Life Sciences

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