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.
To review the draft second edition FACT Standards for Immune Effector Cells, go to Draft second edition IEC Standards . To assist in your review, we have uploaded a redlined version of the Standards, DRAFT IEC Redlined Document. For instructions and to submit your comments(s) go to IEC Redcap Survey.
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.
To review the draft second edition FACT Standards for Immune Effector Cells, go to Draft second edition IEC Standards. For instructions and to submit your comments(s) go to IEC Redcap Survey.
The March 2023 Telegraft Hub published an article titled, Continuing FACT’s Tradition of Consensus Building into the Next Wave of Cellular Therapies: Incorporating Multistakeholder Perspectives into FACT Accreditation and Assessment & Audit ServicesBelow are notable excerpts:
FACT has collaborated with multistakeholder groups since it was founded in 1995. Our very genesis was the result of collaboration between the American Society for Transplantation and Cellular Therapy (ASTCT) and the International Society for Cell & Gene Therapy (ISCT) to develop the first comprehensive set of Standards for hematopoietic progenitor cell transplantation. Since then, FACT has worked with many organizations. In 1999, we co-published the Hematopoietic Cell Standards with JACIE to expand quality beyond U.S. borders. In 2000, we partnered with NetCord, now part of WMDA, to create standards and accreditation for cord blood banking. Since 2013, we have served as a recognized accreditation for the United States National Cord Blood Inventory (NCBI) and have conducted supplementary inspections against NCBI-specific criteria. We also partner with organizations on quality initiatives, such as the joint Data Audit Committee with the Center for International Blood & Marrow Transplant Research (CIBMTR). Other stakeholders we work with include ICCBBA, the American Society for Apheresis (ASFA), the Cord Blood Association (CBA), Be the Match, and more.
The Advent of Commercially Manufactured Cellular Therapies and the Need for Multistakeholder Cooperation
Following successful clinical trials of chimeric antigen receptor (CAR) T cell therapies, FACT published its Standards for Immune Effector Cells in 2017 and implemented an associated accreditation program at the request of accredited programs, FACT inspectors, and payers. The commercialization of the first licensed CAR T cell products that year led FACT to expand our circle of collaborators to commercial and clinical trial product manufacturers.
FACT’s first interactions with our manufacturer colleagues consisted of telephone calls, emails, and in-person introductions. Through comparison of FACT Standards to manufacturers’ audit checklists, review of manufacturers’ audit observations, and communication on challenging issues between industry and health care sites, we identified ways to clarify or add to our Standards to maintain the relevance of FACT requirements amid the exciting evolution of cellular therapies. We also demonstrated that our robust accreditation program can accommodate the transition from clinical research to commercialized therapies at sites while fulfilling regulatory obligations of manufacturers.
FACT Participation in Multistakeholder Groups
Multistakeholder groups have generated ideas and practical solutions that have the potential to reduce bottlenecks in cellular therapies and thereby increase patient access. Though listing all multistakeholder groups is beyond the scope of this article, the following are examples of groups in which FACT participates to address redundancies:
FACT Implementation of Multistakeholder Solutions to Reduce Duplicative Assessments and Audits Via our work with multistakeholder groups, we confirmed that a majority of manufacturers’ needs for assessing collection and treatment sites are already covered by compliance with FACT Standards. Manufacturers need documented assessment of sites that specifically verifies compliance with the applicable regulations as they apply to their cellular therapy products. The following are ways in which FACT is addressing manufacturers’ needs to reduce burden on health care institutions:
Building FACT Assessment & Audit Services
The two main goals of FACT’s assessment and audit services will be to reduce redundant assessments at FACT-accredited sites already qualified to participate in cell therapy and more quickly and effectively qualify additional sites.
If you are interested in participating in the development of FACT assessment and audit services, or utilizing our services, please contact Liz Ferraro, Manager of Assessment and Audit Services, at liz.ferraro@factglobal.org. We plan to incorporate as many perspectives as possible. Our intention is to develop these services to be a WIN-WIN-WIN for health care institutions, manufacturers, and, most of all, patients.
The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application throughout product development and clinical trials.
This third edition of Common Standards remains consistent with previous editions, requiring a comprehensive quality management plan and established clinical, collection, and processing procedures. Additionally, this edition reflects the maturation of cellular therapy and the inclusion of more and diverse products such as genetically modified products. Quality management requirements include specific training in good manufacturing practice appropriate to the products being collected or processed; development and review of robust written agreements with entities providing services or products; comprehensive document control; and expanded auditing, outcome analysis, and data management and reporting requirements.
“The revisions were focused on harmonization with other parallel FACT standards and on advances (real and anticipated) of novel cellular therapies that would be covered under the Common Standards,” according to Dr. Paul Eldridge, Chair of the Common Standards Committee.
In this edition, emphasis is also placed on the criticality of labeling and chain of identity / chain of custody as product manufacturing frequently involves several cooperating entities to achieve collection of the cellular starting material, manufacture of the final product, transport of the cells and products among facilities, and clinical therapy administration. Because of its value in accurate and unambiguous identification, encoding information, and labeling of medical products of human origin, full implementation of ISBT128 coding and labeling is required where possible.
FACT is excited to announce the publication of the first Accreditation Manual to accompany the third edition Standards. Significant thanks is given to Dr. Carolyn Keever-Taylor for her work in drafting the initial document for the committee to review. The Accreditation Manual “provides a valuable tool for users to self-assess their compliance with the Standards and ensure that they are inspection ready,” Dr. Paul Eldridge.
The Common Standards Committee consists of 13 expert members. Members reviewed clinical, collection, processing, and quality requirements. Following months of reviews and revisions, comments were submitted during an open public comment period. The committee considered all feedback, which totaled almost 100 comments, submitted by professionals from industry, clinical, non-profit, and regulatory settings. Final revisions were drafted by the committee and approved by the FACT Board of Directors. The FACT leadership expresses its gratitude to the committee members for their dedication and work to revise this third edition.
The third edition Common Standards become effective March 30, 2023. All organizations accredited under these Standards are expected to be in compliance with the requirements by that date. Compliance Applications under the Common Standards will now only be accepted for the third edition. For organizations currently pursuing accreditation under the second edition, all inspections must be scheduled before the effective date. All inspections scheduled after this date will be under the third edition.
Third Edition Common Standards [free download]
Third Edition Common Standards Accreditation Manual [free download]
Purchase printed copies of Standards
Purchase printed copies of the Accreditation Manual
Download additional supporting documents
NEWS RELEASE
Issued: April 13, 2022
Contact: Linda Miller
OMAHA, Neb. – King Abdulaziz Medical City – Riyadh, Saudi Arabia received internationally recognized accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT). Directed by Mohsen Alzahrani, MD, it is the first and only cellular therapy program in Saudi Arabia to be recognized by FACT. The program received accreditation on July 1, 2022, and is accredited for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Trans-plantation, Marrow and Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing.
Read full news release
NEWS RELEASE
Issued: April 13, 2022
Contact: Linda Miller
OMAHA, Neb. — Foundation for the Accreditation of Cellular Therapy (FACT), the leader in voluntary inspection and accreditation in the field of transplantation and cellular therapy, announces its new website and branding launch.
Read full news release
NEWS RELEASE
Issued: October 25, 2021
Contact: Linda Miller
OMAHA, Neb. — FACT is pleased to announce the first step in efforts to transition to an enhanced website with the establishment of a new email domain and phone numbers.
Read full news release
The eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying eighth edition Hematopoietic Cellular Therapy Accreditation Manual have been officially published.
The objective of the FACT-JACIE Standards is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoietic derived cellular products. FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.
The scope of the Standards includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.
The eighth edition Standards become effective on August 16, 2021. All organizations accredited under these Standards are expected to be in compliance with the requirements by that date. Although there may be a few inspections remaining to be completed under the previous edition due to COVID 19-related delays, all other inspections scheduled after this date will be under the eighth edition.
Review the Summary of Changes for the eighth edition FACT-JACIE Standards
Download the eighth edition FACT-JACIE Standards for free
Download the eighth edition Hematopoietic Cellular Therapy Accreditation Manual for free
Purchase printed copies of the eighth edition FACT-JACIE Standards
Purchase printed copies of the eighth edition Hematopoietic Cellular Therapy Accreditation Manual
Download additional supporting documents
NEWS RELEASE
Issued: October 25, 2021
Contact: Linda Miller
OMAHA, Neb. — The Foundation for the Accreditation of Cellular Therapy (FACT) is pursuing an opportunity to establish independent operational functions by the end of 2021 thus ending the 25-year collaborative relationship with the University of Nebraska. Read full release
To assist entities with determining ISBT 128 registration fees, ICCBBA created a registration license fee flyer.
View the flyer.
In October and November 2020, 11 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.
In September 2020, five entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.
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