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Mid-Atlantic Biochemical Engineering ConsortiumMABEC 2003 KeynoteDevelopment and Scale-Up of Synagisâ
David A. LindsayMedImmune, Inc.Gaithersburg, Maryland
AbstractTime-to-market has always been critical to the success of a biopharmaceutical product journeying down an R&D pipeline. Process development plays a central role in setting the pace of a product development program. The speed of development needs to be carefully balanced with the performance of the resulting production process as measured by its robustness, efficiency, and ease of scale-up. Prior to market approval, a manufacturing strategy should be in place to anticipate demand growth and secure product supply. An emphasis on continuous yield enhancement can steadily improve the process economics. In this presentation, we will use Synagisr, a humanized monoclonal antibody against Respiratory Syncytial Virus, as a case study to highlight the key issues involved in advancing from development stage to commercial manufacturing of a biotech product.
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