Comments Requested on Draft Second Edition FACT Standards for Immune Effector Cells

Posted in :: 2023 Volume 1 :: Thursday, March 30th, 2023

The Foundation for the Accreditation of Cellular Therapy (FACT) will publish the draft second edition FACT Standards for Immune Effector Cells on March 31, 2023, for public comment during a thirty-day period. Comments will be accepted through April 30, 2023.

These Standards promote quality practice in immune effector cell therapies and apply to a wide range of immune effector cells used to modulate an immune response for therapeutic intent, whether genetically modified or not. This includes, but is not limited to, dendritic cells, natural killer cells, T cells, B cells, genetically engineered chimeric antigen receptor T cells (CAR-T cells), and therapeutic vaccines. The final Standards will be published in November 2023 and will become effective in February 2024.

The FACT Standards for Immune Effector Cells were reviewed and commented upon during an initial public comment period in association with the eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. The majority of comments received have been addressed through harmonizing these two publications.

Comments submitted during the first comment period clearly indicated a need to enhance standards related to cell collection. These comments have been addressed in B2.12, B2.12.1, and in a reorganized Section C that now includes general standards applicable to any cell collection followed by sections C9, C10, and C11 specific to apheresis and whole blood collection, marrow collection, and collection of other tissues such as tumor-infiltrating lymphocytes (TILs).

The purpose of this comment period will be to specifically request your comments on these new sections. Two versions of the published draft are available. One is a clean version, and the other is a redline document intended to highlight the changes made to these Standards. Minor reorganization and clarifying changes are not tracked. Some changes are new standards; however, some are intended to clarify rather than to change the intent. In addition, many changes were made to provide consistency among all sets of FACT Standards:

If you have any questions, please contact Monique Summers, FACT Standards Development Manager at or 402-920-7010.