In This Issue

Accreditation Statistics

As of August 1, 2023

Cellular Therapy Entities

  • Accredited: 255
  • Applicants: 26

Cord Blood Banks

  • Accredited: 53
  • Applicants: 9

Congratulations to the following organizations for achieving initial accreditation:

Pennsylvania Hospital, Penn Medicine: Adult autologous hematopoietic progenitor cellular therapy, peripheral blood cellular therapy product collection, and cellular therapy product processing with minimal manipulation

Sarah Cannon Transplant & Cellular Therapy Program at MountainView Hospital: Adult autologous hematopoietic progenitor cellular therapy, immune effector cellular therapy administration, peripheral blood cellular therapy product collection, and cellular therapy product processing with minimal manipulation

A complete list of accredited organizations can be found at www.factglobal.org.

REMINDER: Public Comment Period Open for FACT Cellular Therapy Standards and Immune Effector Cell Standards

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

FACT – JACIE International Cellular Therapy Standards

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) published the draft Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment. These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood.

Description and Instructions for Review and Comment
Summary of Changes
Draft Eighth Edition FACT-JACIE International Standards

Comments regarding the draft Eighth Edition FACT-JACIE International Standards can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.

FACT Standards for Immune Effector Cells

The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Second Edition FACT Standards for Immune Effector Cells for inspection and public comment. 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, but is not limited to, genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

Description and Instructions for Review and Comment
Summary of Changes
Draft Second Edition FACT Standards for Immune Effector Cells

Comments regarding the draft Second Edition FACT Standards for Immune Effector Cells can be submitted by accessing the Comment Form. Comments will be accepted through August 30, 2020.

For questions or assistance, please contact Andra Moehring, MHA, Standards Development Manager.