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Cell & Gene Therapy
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Gene-Edited Cell Therapies: CMC Challenges and Considerations - WHITEPAPER

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Gene-edited cell therapies showed potential as a treatment for many diseases, especially for blood-based cancer patients who do not respond to any other treatment. And presently, CAR T cells are increasingly being reprogrammed to express small molecules and drugs that can serve as an addition to existing therapies.

This whitepaper reviews the current challenges in manufacturing gene-edited cell therapies and steps to approach them, including:

  • Manufacturing challenges and protocols for gene-edited cell therapies

  • Considerations for allogeneic products, including CAR & T cell products

  • Current industry developments

  • Best practice strategies in maintaining safety/efficacy

  • Opportunities for automation/technological innovation


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