Cell and Gene Therapy - High Quality and Safety from Vein to Vein: CMC Testing for CAR T-Cell Therapies
Chemistry, Manufacturing and Control (CMC) testing is an integral part of the CAR T-cell clinical journey during vector production and T-cell modification. These tests, mandated by the FDA and other regulatory agencies, uphold the safety, purity and potency of the product before being administered to the patient. For each CMC criterion to be met, robust analytical tests need to be optimized and validated. "Living" drugs, such as CAR T-cells, offer a limited time window for testing, thereby adding another layer of complexity. In this white paper, we outline the CMC requirements and corresponding analytical tests for manufactured CAR T products and discuss the common CMC challenges we tackle during a typical CAR T-cell therapy program.