BIOT 249 |
| In today's highly competitive process development environment, the objective is to rapidly bring forward early stage product candidates with minimal time and resource investments. Maximizing efficiency through establishment of a standardized approach to process development is vital to achieving this goal. Hence, we have instituted a platform based approach for cell culture-produced therapeutic protein products. This allows for expedited manufacture of early phase clinical material by eliminating lengthy process development timelines while still achieving process performance capable of supporting clinical programs. Fundamental elements of the platform process developed at Merck include the cell line, medium and feed formulations, operational parameters, step definition, and timing for both the cell expansion and production stages. The work described here demonstrates the utility of this kind of platform in quickly establishing robust and productive fed batch cell culture processes which can be readily implemented in a clinical manufacturing environment. |
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Poster Session
5:30 PM-7:30 PM, Wednesday, August 22, 2007 BCEC -- Exhibit Hall - B2, Poster
Division of Biochemical Technology |