In light of continuing adaptation to accommodate the rapidly expanding cellular therapy field, FACT joined 14 other organizations to issue a consensus statement reaffirming its support of ISBT 128 as the global standard for terminology, coding, and labeling of cellular therapy products. With a growing list of stakeholders and cellular therapy products, real-world experiences highlight the importance of standardized terminology, globally unique identifiers, and internationally readability to protect patient safety.
ICCBBA, the organization that manages ISBT 128, has not only retained ISBT 128’s relevance to changes in transplantation and cellular therapy, but has also collaborated with multistakeholder groups to accommodate various needs within its coding and labeling system. This includes the published ISBT 128 Labeling of Collection Products for Cellular Therapy Manufacturing Standard and continued participation on initiatives to streamline chain of identity and chain of custody practices. These are examples of ICCBBA’s abilities to leverage existing standards and infrastructure to meet terminology, coding, and labeling needs that are in high demand.
The consensus statement recognizes the following:
- “the quality and safety benefits of globally unique identification and common and consistent terminology, coding and labeling for all cellular therapy products;
- the importance of an agreed common structured terminology to describe cellular therapy products both for the labeling of product for clinical application, and in the scientific literature to describe the development of products from pre-clinical development, through clinical trials, to clinical use;
- the work done by the ISCT MSC Committee to promote the use of a standardized terminology for mesenchymal stromal cells (MSC) and their source tissue, and the subsequent harmonization between this terminology and ISBT 128;
- the widespread adoption of ISBT 128 as the global standard for the terminology, coding and labeling of cellular therapy products; and,
- the rapidly growing field of cell therapy manufacturing, and the developments within ISBT 128 to provide nonproprietary name and clinical trial specific product description codes.”
The statement goes on to encourage the use of ISBT 128 at all stages of cellular therapy product development, within scientific literature, and by all relevant stakeholders.