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Regulatory Challenges: Product Quality (CMC) Challenges and Opportunities

Regulatory Challenges: Product Quality (CMC) Challenges and Opportunities



Miami, Florida

The promise of cell and gene therapies is tempered by the challenges associated with achieving patient access. For autologous cell therapies, we know that shortening the time between starting material collection and patient dosing leads to improved clinical outcomes. Accelerated clinical programs create compressed timelines for CMC activities and development of robust process controls. Carol Houts from Germfree and David Lewandowski from Azenta will be discussing some of the unique CMC regulatory challenges found with cell therapy products produced using a distributed or POC manufacturing models.

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