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Addressing Performance, Scalability, and Regulatory Challenges to Accelerate Cell Therapy Manufacturing

To date, the FDA has approved 36 cell and gene therapy products. In the past decade, new cell therapy modalities such as chimeric antigen receptor T-cell (CAR-T) immunotherapies have emerged as promising treatments especially for many types of cancers. There are now six FDA approved commercially available CAR-T products and the development of cell therapies is continuing to gather pace with over 1600 in active clinical development.

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