day one | day two

Day OneDecember 10, 2007 08:00 EVENT REGISTRATION & COFFEE 09:00 CHAIRPERSON'S OPENING REMARKS Laura Bush, Editor in Chief, Biopharm International 09:05 FUTURE DIRECTIONS IN MONOCLONAL ANTIBODY DEVELOPMENT & PRODUCTION Latest technologies in generating effective antibody leads Latest developments to achieve speed-to-clinic cell lines and processes Methods of ensuring success of commercial antibody production processes Regulatory implications and considerations to support cell line and process changes Dr. Kevin Bailey, Vice President, Process Develo, Regeneron Pharmaceuticals 09:40 INTEGRATED PROCESS DEVELOPMENT: EFFICIENTLY BALANCING UPSTREAM & DOWNSTREAM Reducing batch processing time and improving facility output through simple non-Protein A purification processes Optimizing conditions to remove process related contaminants on ion exchange resin vs. affinity chromatography Dr. Alahari Arunakumari, Senior Director, Process Devel, Medarex USA 10:15 Morning Refreshments 10:40 INTERACTIVE WORKSHOP STRATEGIES TO PURIFY MONOCLONAL ANTIBODIES WITH CERAMIC HYDROXYAPATITE Science behind the separation power of CHT Use for purification of monocloncal antibodies Dr. Mark Snyder, Manager, Process R&D Applicati, Bio-Rad Laboratories   INTERACTIVE WORKSHOP DISPOSABLES IN ACTION Disposable solutions: A combination of products, applications support and services Regulatory requirements and validation data Case study - Pharmaceutical Company in Europe with Product X. Edward Graham-Brown, Vice President Strategic Marke, Millipore Johan Westman, VP Advanced Manufacturing Solu, Millipore   11:15 Maintaining successful relationships with external manufacturing facilities during expansion efforts Dr. Adam Sabouni, Vice President, Global Pharmac, Stiefel Laboratories   CURRENT ISSUES IN FERMENTATION Optimizing cell culture methods Modernizing vaccine production through utilizing the cell-based platform Allan Taggart, Vice President, Government Pro, MedImmune   11:50 Innovative tools and technologies to achieve process excellence High volume biomanufacturing constraints: Quality, Compliance and Technology The rationale behind process excellence: continuous improvement and process consistency Examples of achieving process excellence using multivariate modelling, PAT, and computational fluid dynamics Dr. Sourav Kundu, Director, Manufacturing Scien, Amgen 12:25 IMPLEMENTING DISPOSABLE TECHNOLOGY TO BIOMANUFACTURING Overcoming key challenges during implementation efforts Evaluating the future of disposable bioreactors Understanding the cGMP and regulatory perspectives Dr. Sadettin Ozturk, Head, Bioprocess Technology, Centocor Biologics 13:00 HOSTED LUNCHEON 14:00 Enhancing bioprocessing methods through novel techniques Case study: boosting productivity through effective antibody cell line development Isolation, characterization and production of cross-neutralizing Human monoclonal antibodies against SARS and Henipa Viruses Dr. Zhongyu Zhu, Scientist, SAIC Frederick NCI 14:40 ONE-TO-ONE MEETINGS 18:00 UPGRADING PROCESS DEVELOPMENT TECHNIQUES: MAINTAINING COMPLIANCE AND QUALITY STANDARDS Efficiently scaling up processes to improve reliability Scaling up therapeutic protein and monoclonal antibody drug substance processes Achieving efficient technology transfer when scaling up processes Identifying critical parameters in process characterization and validation Understanding key features in robust process design Dr. Maninder Hora, Vice President Process Develop, PDL Biopharma USA 18:35 NETWORKING DRINKS RECEPTION

day one | day two

Day TwoDecember 11, 2007 08:00 REGISTRATION & COFFEE 09:00 CHAIRPERSON'S OPENING REMARKS AND RECAP OF DAY ONE Laura Bush, Editor in Chief, Biopharm International 09:05 MAXIMIZING PRODUCT OPERATIONS BY APPLYING LEAN PRINCIPLES From concept to product: applying class A principles to streamline production efforts Resource capacity modeling Leveraging innovation projects Examples of success Dr. Sue E Steven, Senior Director, Process Resea, Genentech 09:40 IMPROVING THE BOTTOM LINE WITH PROCESS EXCELLENCE Upgrading lean manufacturing techniques Visual Lean: The madness, the method and the money William P. Botha, Director of Manufacturing, Baxter Bioscience   MAXIMIZING EFFICIENCY WITH PROCESS ANALYTICAL TECHNIQUES Online process monitoring; how useful is it during downstream? Can PAT be used in downstream (purification) applications? 3 potential examples of PAT implementation including a chemical reaction, a chromatography step and a UF/DF step How PAT systems could be configured to be run in a GMP environment Dr. Robert Gronke, Principal Scientist, Biogen Idec   10:15 Case study: Process Validation in Design Space Fulfilling the expectations behind QbD Excelling in risk-based manufacturing techniques Mark Roach, Director of Validation, Bayer Healthcare 10:50 MORNING REFRESHMENTS 11:10 EMPHASIZING DOWNSTREAM: THE FUTURE OF PURIFICATION Scale-up and scale-down approaches of robust purification processes Ensuring successful project transfers and maintaining compliance throughout Dr. Arne Staby, Head of Protein Separation, Novo Nordisk Denmark 11:45 BEST PRACTICES IN FILTRATION AND EXTRACTION TECHNIQUES Evaluating chromatography platforms and separation methods Recent progresses in novel liquid-liquid extraction/ chromatography technology Ian Sutherland, Director, Institute of Bioengineering, Brunel University UK 12:20 THEMED LUNCH DISCUSSIONS 13:20 CURRENT AND FUTURE REQUIREMENTS IN DOWNSTREAM PROCESSES Understanding the limitations in downstream: catching up with advances in fermentation To what extent can disposable technology bring potential solutions to the downstream challenge? Reaping the benefits of emerging technologies to help solve the purification bottleneck Dr. Uwe Gottschalk, VP Purification Technologies, Sartorius AG 13:55 THE DOWNSTREAM BOTTLENECK - MYTH OR MENACE? Panel discussion Does the downstream bottleneck really exist? Effective strategies to overcome potential downstream bottlenecks Can older technologies be re-applied in purification? Can anything eliminate the bottleneck? Dr. Uwe Gottschalk, VP Purification Technologies, Sartorius AG David Peers, Manager, Recovery MSAT, Genentech Dr.Gustavo Mahler, VP and Head of Technical Opera, Bayer Healthcare Edward Graham-Brown, Vice President Strategic Marke, Millipore 14:30 BIOMANUFACTURING 2007 AND BEYOND Incorporating the tools needed to efficiently manage a commercially-focused operation Creating a team of excellence Mary Kuhn, Senior Vice President of Opera, Talecris Biotherapeutics 15:05 CHAIRPERSON'S CLOSING REMARKS