Starting (Material) with Confidence: How the Apheresis Collection Standard Helps Cell & Gene Therapy

SCB, with subject matter experts Tracey Hlucky, CQA, CMQ/OE (ASQ), of Kite Pharma/Gilead, J. Wade Atkins, MS, MT(ASCP) SBB, CQA, CABP(H), of the NIH Clinical Center, and Monique Summers-Currington, RN, MSN, MPA, of the Foundation for the Accreditation of Cellular Therapy (FACT), presented on the newly published PDA/ANSI Standard 08-2026, Apheresis Collection for Cell and Gene Therapy Products, which defines minimum requirements for the apheresis collection process for cell and gene therapy manufacturers. The webinar addressed the increased workload on apheresis centers as they support more manufacturers, products, and patients, and the standard's goal of reducing their burden. To help meet this goal, the standard sets common definitions and documentation requirements while allowing manufacturers to retain their required parameters. Because not all requirements can be standardized, it also provides a template for manufacturers to communicate their required parameters, making it easier for apheresis centers to find and implement each manufacturer's requirements.