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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.
Modern medicines call for modern technologies. Revolutionary cell and gene therapies offer significant promise to treat life-threatening diseases. Getting therapies to market quickly and efficiently requires accurate testing of critical quality attributes, including accurate viral vector analysis…
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…