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Session VI - Cell Therapies
Date
June 7, 2022
This product is not available for individual purchase, but it is available as part of the following products:
The Cell and Gene Therapy Products (CGTP) Symposium: Manufacturing, Quality and Regulatory Considerations enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products…
The Cell Therapies products space is continuing to build on the potential for innovative treatments for unmet patient needs. Topics include cell products with unique manufacturing process, complex sourcing starting material, and assays with direct relevance to CQAs. This session will provide insights into early CMC development and points to consider for cell therapies.
Session Chairs
Related Products
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Potency is a critical quality attribute (CQA) for cell and gene therapy (CGT) medicinal products…
Identity testing by NGS as a means of risk mitigation
Imagine that you just completed a manufacturing run for a mission critical gene therapy vector. All of your release testing is underway, and you are days away from releasing your product. Per regulatory guidelines, identity testing is performed to confirm the vector sequence is as expected…
