FACT is pleased to announce that ICCBBA, administrator of the ISBT 128 coding and labeling standard, has released a draft document and label for public review and comment. The document, “Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing,” and the described label applies to collected cells, commonly referred to as “starting material,” intended for further manufacturing in support of clinical cellular therapy trials and commercial cell products. This draft is a result of a multi-stakeholder effort to standardize labeling requirements of apheresis collection facilities, including the Standards Coordinating Body, the Deloitte NextGen Industry Working Group, FACT, and many others.

Variations in sponsors’ labeling requirements have been a notable challenge for apheresis facilities in recent years and introduce risks of errors and misinterpretation of patient data. The use of an ISBT 128-compliant label will reduce manual transcription errors and promote chain of identity, including for autologous cells. Furthermore, the use of ISBT 128 for these collections will allow the use of processes, labels, equipment, and software compatible with those already in use for other types of cellular therapy products collected by apheresis facilities for clinical application.

The next step of this important standardization effort is to solicit input from the entire community. Please review this document and provide comments by March 20, 2020 to Dawn Henke of the Standards Coordinating Body (dhenke@regenmedscb.org). Equally important, please distribute this announcement to your industry, hospital, vendor, and professional colleagues to make them aware of this opportunity and encourage them to review the document and submit feedback.

Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing

Submit Comments (due March 20, 2020)

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