Quality indicators for cell collections for immune effector cell and gene therapy: recommendations from the American...

Immune effector cell (IEC) therapies provide increasingly important treatment options for patients with certain hematologic malignancies. Apheresis comprises a critical step, providing the starting material from which peripheral-blood derived IEC therapies are manufactured. Regulatory and accreditation bodies providing laws, regulations, guidance, and standards appropriately impose high quality goals for apheresis collection facilities, but they are often not all congruent with clinical trial requirements. Multiple efforts are underway to standardize apheresis procedures for IEC therapies. However, few publications give practical guidance on establishing quality indicators for apheresis collection facilities. Recognizing this, the American Society for Apheresis (ASFA) Clinical Applications Committee (Immune Effector Cell Therapy Subcommittee) sought to review and define the quality indicators that can be applied at each phase of the collection process. This paper is primarily focused on apheresis collection facilities in the United States (US), but general concepts may be applicable outside of the US as well. These recommendations are also endorsed by the Foundation for the Accreditation of Cellular Therapy (FACT), Association for the Advancement of Blood and Biotherapies (AABB), and International Society for Cell & Gene Therapy (ISCT).