Monday, July 27, 2009 - 2:00 PM
S37
Bioprocess Development To Enable Successful Scale –Up And Tech Transfer Toward Bioproduct Commercialization Development
Xuejun Sherry Gu, Bioprocess R&D, Eli Lilly, Lilly Corporate Center, Indianapolis, IN 46285
Effective and streamlined bioprocess development effort can contribute significantly toward the successful scale up and tech transfer activities, which are inevitable and essential steps for clinical trials and commercialization. Lilly is moving towards that direction through a number of integrated efforts, including implementing a Single Process Map framework for drug development; designing molecules for success; implementing platform-based drug development; leveraging QBD tools and approaches to streamline API development; aligning common technical document content with the future state.
Examples of tech transfer effort for both early and late stage projects will be shared in this presentation to highlight the progress we have made and challenges ahead of us.
Examples of tech transfer effort for both early and late stage projects will be shared in this presentation to highlight the progress we have made and challenges ahead of us.
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