Manufacturing and Quality Control in CAR T-Cell Therapy
CAR T-cell therapy is a highly personalized treatment that depends on precise manufacturing and strict quality control. Each therapy is created using a patient’s own immune cells, making consistency and safety essential.
The process begins with leukapheresis, during which T cells are collected from the patient’s blood. These cells are transported to specialized facilities where genetic modification introduces the chimeric antigen receptor. The modified cells are then expanded to achieve sufficient therapeutic quantity.
Quality control measures ensure cell viability, genetic accuracy, and sterility. Extensive testing confirms that the CAR construct is expressed correctly and that cells meet predefined safety criteria before release.
Manufacturing timelines require careful coordination to minimize delays while maintaining quality. Any deviation can affect treatment effectiveness or patient safety.
Ongoing innovations aim to streamline production, reduce variability, and enhance reliability. High manufacturing standards are fundamental to successful CAR T-cell therapy outcomes.