FACT Publishes Second Edition Immune Effector Cell Standards
FACT has published the second edition FACT Standards for Immune Effector Cells to be effective March 15, 2024.
These Standards promote quality medical and laboratory practice in immune effector cell therapies. These therapies include a wide range of cells that effect or modulate an immune response for therapeutic intent, whether genetically modified or not, such as T-cells, B-cells, natural killer cells, dendritic cells, genetically engineered chimeric antigen receptor T-cells (CAR-T cells), and therapeutic vaccines.
The FACT Standards for Immune Effector Cells were developed by consensus of experts in the field, reviewed during two public comment periods, and harmonized with the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Significant changes were introduced to reflect advances in the field and incorporate evolving cell collection types and practices. The FACT Standards for Immune Effector Cells are specifically intended for programs and persons using these therapies outside of hematopoietic cell transplantation.
These Standards are available for download, or printed copies can be ordered.
