Monday, November 13, 2006: 3:15 PM-5:45 PM
Union Square 25 (Hilton San Francisco)
#151 - Strategies in Biopharmaceutical Scale-up & Pilot Plants (T5003)
While reducing the timelines to market is still a challenge, adopting efficient scale-up and technology transfer strategies in the biopharmaceutical industry is critical. In this race to commercialize new technology, or to improve existing technology, it is widely accepted that pilot plants play a key role in the overall process development scheme. Therefore, this session is particularly interested in topics that include, but are not limited to, scale-up approaches and troubleshooting for upstream and downstream processes, unique technology transfer strategies, design and operation of pilot plants, case studies on processes that are scaled-up in pilot plants that demonstrate a unique team approach and delivery under aggressive timelines and budget limitations.
Chair:Nihal Tugcu
CoChair:Jeanette Beard
3:15 PMIntroductory Remarks
Part 1 
3:20 PMCell Culture Scale-up and Technology Transfer for 12,000 L-Scale Therapeutic Antibody Manufacturing
John Fann, John Ponzo, Ziran Sun, Seshu Tummala, Clara Teijido, Min Wan, George Avgerinos
3:41 PMStrategy to Fit a Downstream Purification Platform for an Early Stage Development, Therapeutic Protein into an Existing Pilot Plant
Francis M. Torres, Nguyen V. Ly
4:02 PMThe Role of Process Modeling in Bioprocess Development and Technology Transfer
Charles Siletti, Demetri P. Petrides
4:23 PMMulti-Dimensional Model for Prediction and Scale-up of Lyophilization
Pavol Rajniak, Jiri Placek, Joseph Schaller, Rajiv Mahajan, Rey Chern
4:44 PMScale up of Fluid Mixing Parameters in Bio-Pharmaceutical Processes
James Y. Oldshue
5:05 PMFrom Petrochemicals to Pharmaceuticals: Rapid Scale-up of Penicillin by an Academia-Industry Consortium Including Shell Development Company during World War II
Joseph B. Powell

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