CAR-T (Chimeric Antigen Receptor – T-cell) is a growing field of autologous therapies that use a patient's own immune system to help fight diseases such as cancer. These biological products are unique in that they are produced by adding chimeric antigen receptors (CARs) to a patient’s T cells; the CAR can recognize and attack cells that display a target protein (antigen), including cancer cells. These therapies require a firm understanding of the requirements associated with the operations and supply chain while having the ability the think outside the box when challenges arise.
CAR-T operations are special in the industry because each “batch” goes to a single patient. This requires a strong coordination of materials, personnel, and equipment. In addition, the circular nature of the supply chain creates a special set of challenges for the supply chain participants, including the manufacturer, treatment center and shipping company.
This session, presented by Aaron Weinstein, Senior Director, Validations Services, will focus on the challenges that are inherent to the CAR-T operations and supply chain including coordination with treatment centers, materials management, Chain of Identity (COI), batch segregation, management of large staffs over multiple shifts, portable vs. in-place equipment, temperature control and monitoring, time sensitivity, and communication between all parties in the supply chain.
More information and registration for INTERPHEX 2021 can be found here: https://www.interphex.com/