The Why, What, and How of the New FACT Standards for Immune Effector Cells #

Dr. Sarah Nikiforow, of the Dana Farber Cancer Institute, and Dr. Marcela Maus, of Massachusetts General Hospital, are both members of the FACT Immune Effector Cell Task Force and have written an article published in the Journal of ImmunoTherapy of Cancer, outlining the why, what, and how of the new FACT Standards for Immune Effector Cells.

Drs. Nikiforow and Maus discuss how FACT has established new Standards specific to the use of Immune Effector Cells (IEC), including gene-modified T cells and natural (NK) cells. These Standards specify the clinical and quality infrastructure to facilitate safe administration of immune effector cells and formalize subsequent monitoring and reporting of patient outcomes to enable continual process improvement. The authors detail why these Standards came into being, what they entail, and how a clinical team might access educational materials and implement these Standards. We propose that these Standards will be increasingly useful and relied upon as institutions and clinical service lines seek access to these treatments for their patients.
Read the entire journal article here

Wallchart: Production of Chimeric Antigen Receptor T cells #

Nature Protocols Recipe for Researchers, and Stemcell Technologies, along with Andrew D. Fesnak, Megan M. Suhoski Davis, and Bruce L. Levine, created a comprehensive chart that outlines collection through formulation, delivery, and administration of Chimeric Antigen Receptor T cells (CAR-T cells). This wallchart may be useful to cellular therapy programs for education and procedural development.
Access Wallchart: Production of CAR T Cells here

Bebé Vida is first Cord Blood Bank in Portugal to earn FACT accreditation #

OMAHA, Neb. – Bebé Vida in Portugal received internationally recognized accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) at the University of Nebraska Medical Center. Bebé Vida, directed by Marika Bini Antunes, MD, is the first and only cord blood bank in Portugal to be recognized by FACT. The bank received accreditation on April 28, 2017, and is accredited for banking cord blood for private family use. Read full release

Draft 7th Edition FACT-JACIE Standards Available for Public Comment #

The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) have published the draft 7th edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment for a 90-day period. Comments will be accepted from May 1, 2017 through July 30, 2017.

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, and administered by a FACT or JACIE-accredited blood and marrow transplant team.
Description and Instructions for FACT-JACIE Standards
Draft FACT-JACIE Standards
Draft FACT-JACIE Manual

To submit comments regarding the draft 7th edition FACT-JACIE Standards, follow the steps below. Comments will be accepted through July 30, 2017.

1. Access the Comment Form at https://www.surveymonkey.com/r/FACT-JACIE.
2. Type in your contact information and comments on the form. Fill in all fields so that the Standards Committee fully understands your position.
3. Submit the form when you are finished. Once the form has been submitted, it cannot be changed. However, additional comments may be submitted by completing the form again. There is no limit to the number of forms that can be submitted.

Summary of 13th Cell Therapy/FDA Liaison Meeting Now Available #

The FDA CTLM Meeting, on October 19, 2016, addressed several hot topics in cellular therapy. Representatives from the cellular therapy field and from the FDA presented information on each of the topics. A summary of these presentations, and the presentation slides, are now available.
Read Final Meeting Summary

News Release: FACT Publishes First Edition of Immune Effector Cell Standards #

NEWS RELEASE Issued: February 3, 2017 Contact: Linda Miller

OMAHA, Neb. – The Foundation for the Accreditation of Cellular Therapy (FACT) is pleased to announce it has published standards for immune effector cells. The new requirements, included within interim standards for the sixth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Collection, Processing, and Administration and within the new, first edition FACT Standards for Immune Effector Cells, apply to 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.Read full release

FACT Publishes First Edition of Immune Effector Cell Standards #

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. 

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 with the understanding 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. To the extent that 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. 

FACT Standards for Immune Effector Cells
Immune Effector Cell Accreditation Manual
Frequently Asked Questions
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