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W102 - Comparability for Cell and Gene Therapy Products

‐ Jun 10, 2020 11:40am

Comparability is a significant challenge for advanced therapies due to issues such as complexity of the products, limited amounts of material available for testing, patient-specific variability, and short shelf life. In addition, in many cases early clinical success is driving shortened development timelines that impact the timing of manufacturing changes. This session will focus on some of the challenges and strategies to address comparability for advanced therapies. The session will address both recent regulatory updates related to comparability and sponsor experience addressing comparability.


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