CAR-T Manufacturing: Delivering on the Promise of a Transformational Therapy

CAR-T cells have been proven clinically to be life-saving therapies for a number of hematological cancers, and offer further promise for additional hematological indications as well as for solid tumors. Commercializing these CAR-T therapies offers numerous challenges in all areas of drug development, including manufacturing and supply chain. Raw material procurement, patient tracking, cost-effective and robust manufacturing, process changes and comparability, process and assay validation, QC/QA release, manufacturing facility strategies, staffing models, and cold supply chain are among the many technical challenges that will be discussed in this presentation.