MABEC 2003
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College of Engineering
Chemical Engineering
Timothy Barbari
William Bentley
Tracey Holoman
Maria Klapa
Nam Sun Wang

  

Mid-Atlantic Biochemical Engineering Consortium

MABEC 2003 Keynote


Development and Scale-Up of Synagisâ

David A. Lindsay

MedImmune, Inc.

Gaithersburg, Maryland

Abstract

Time-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.

©2003 Nam Sun Wang nsw@eng.umd.edu