Kara Wacker, Strategic Planning Administrator
Foundation for the Accreditation of Cellular Therapy
Omaha, NE USA
FACT has added specificity to the scope of accreditation for cell collection. Beginning in July 2024, the online list of FACT-accredited organizations and accreditation certificates now specify two different intents of collection: collection for administration and collection for further manufacturing.
Previously, FACT accreditation encompassed all collections performed by the accredited organization, irrespective of the intended use of the collected cells. While this approach has historically served the blood and marrow transplant programs effectively, the evolving landscape of cellular therapy demands a more refined approach.
With the increasing utilization of cells collected by apheresis for further manufacturing purposes, it has become important to distinguish between collections intended for administration to patients and those earmarked for subsequent manufacturing processes. Although our inspection and accreditation scope already encompass collection for further manufacturing, we recognize the need to explicitly acknowledge this distinction in our accreditation listing.
No new standards are needed to address the purpose of the collection. However, the implementation of certain standards – particularly for labeling, storage, and transportation – may be expanded in the Collection Facility as cell collections are used for different intents. In addition, accredited facilities frequently collect cells at several different collection sites that are detailed on the FACT Facility Grid in the Compliance Application. Some sites may be more appropriate for the different types of donors and collections.
FACT believes that the addition of this enhanced designation to our accreditation listing will underscore to manufacturers that the Collection Facility adheres to FACT Standards for the collection of cellular starting materials for advanced therapies and/or research purposes. Currently, the most common purpose for this type of collection is for immune effector cell therapies.
Collection Facilities eligible for the designation “for further manufacturing” are those that collect cells that are further manipulated into a final cellular product intended for administration to a patient. These Collection Facilities must list those collections and collection sites on their FACT Compliance Application Grid.
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