The first edition of the FACT Standards for Immune Effector Cells has been published. These Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.
Transplant programs that also administer immune effector cell programs should refer to the FACT-JACIE Hematopoietic Cell Therapy Standards for a complete set of requirements pertaining to both HPC transplant and immune effector cells. (Compliance with the immune effector cell standards by March 1, 2017 is required of FACT-accredited programs performing this type of therapy.) Stand-alone immune effector cell therapy programs should reference the FACT Immune Effector Cell Standards. Applications for accreditation of these programs will be accepted in February. More details will be forthcoming. In the meantime, a self-assessment tool is available to help stand-alone programs prepare.
The scope of the Standards includes donor selection and management, administration of cells, management of adverse events, and evaluation of clinical outcomes. The Standards require a quality management (QM) program that establishes, maintains, monitors, and implements improvements in the quality of facilities, processes, and performance.
These Standards were prepared under the assumption that some programs will be responsible for collection and processing of immune effector cells. Regardless of where the product comes from, the program must meet clearly defined responsibilities for chain of custody, storage, verification of product identity, and management of adverse events. In so far as a program is responsible for collection of cells, manufacturing of the cellular therapy product, or preparing the product for administration, the collection and processing requirements in the FACT Immune Effector Cell Standards apply.