Topical 5: Pilot Plant Design and Optimization | |||
| Session 151 - Strategies in Biopharmaceutical Scale-up & Pilot Plants | |||
| 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 | ||
| CoSponsor(s): | Pilot Plants Pharmaceuticals (See also Topical 2) Topical 2: Discover, Development and Delivery of Medicines | ||
| Introductory Remarks | |||
| Part 1 | |||
| 151a | Cell 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 | ||
| 151b | Strategy to Fit a Downstream Purification Platform for an Early Stage Development, Therapeutic Protein into an Existing Pilot Plant Francis M. Torres, Nguyen V. Ly | ||
| 151c | The Role of Process Modeling in Bioprocess Development and Technology Transfer Charles Siletti, Demetri P. Petrides | ||
| 151d | Biologics Pilot Plant Renovation to Enhance Bioreactor and Facility Capacity and Flexibility Jason Fletcher | ||
| 151e | Multi-Dimensional Model for Prediction and Scale-up of Lyophilization Pavol Rajniak, Jiri Placek, Joseph Schaller, Rajiv Mahajan, Rey Chern | ||
| 151f | Scale up of Fluid Mixing Parameters in Bio-Pharmaceutical Processes James Y. Oldshue | ||
| 151g | From 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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