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Hi E, The most recent draft guidance from the U.S. Food and Drug Administration (FDA) on CAR T-cell development, “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products,” includes recommendations for tracking and monitoring CAR T therapy—from preclinical testing through clinical manufacturing and tracking patients for 15 years post-infusion utilizing T-cell receptor (TCR) sequencing. For those developing and producing CAR T therapies, it is important to know how to execute against this guidance.
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