Advanced Cell Therapy product release containing CAR-T cells

Abstract

Manufacturing of customized gene or cell therapy products such as CAR-T cells is complex and depends on release tests and exams that can attest to a consistent quality standard for each product. The quality of CAR-T cell products is subject to donor variation, but also includes the manufacturing environment, as well as the quality and availability of materials and reagents. Quality must be carefully monitored and integrated into the manufacturing process.