Public Review and Comment

FACT Standards for Immune Effector Cells

The Foundation for the Accreditation of Cellular Therapy (FACT) has published the draft second edition FACT Standards for Immune Effector Cells 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 is to specifically request your comments on these new sections. The published draft 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.

Instructions for Submitting Public Comments

To submit comments regarding the draft second edition FACT Immune Effector Cells Standards, follow the steps below. We have included a redline version to assist with your review: FACT IEC Standards Redline.

Comments will be accepted through April 30, 2023.

1. Access the Comment Form at https://redcap.link/IEC2ndEdPublicComments.

2. Enter your contact information and comments on the form. Complete all fields to ensure the Standards Committee fully understands your position.

3. Submit the form when you are finished. After the form has been submitted, it cannot be changed. However, additional comments may be submitted by completing another comment form. There is no limit to the number of forms that can be submitted.

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

Ongoing Feedback on Current Standards

Comments from the public regarding the current Standards and/or Accreditation Manuals may be submitted at any time. Intermittently, it is necessary to update the Standards or Accreditation Manuals based on changes to applicable laws and regulations, field experience, or other reasons. FACT has a process to accommodate needed changes between editions which can be found in the Establishing and Reviewing Standards policy.

To submit a comment please email Monique Summers, Standards Development Manager at monique.summers@factglobal.org.