Cytotherapy Article Reviews Progress of ISBT 128 Labeling, Provides Example of Successful Standardization in Cellular Therapy

Posted in :: 2022 Volume 2 :: Friday, June 17th, 2022

Cytotherapy published a review article titled, “Standardization of cellular therapy terminology, coding  and labeling: a review” (Ashford et. al, 2022)* that describes the introduction of ISBT 128 labeling to cellular therapy in the late 1990s and efforts since then to use the coding and labeling system to promote product identification and traceability. The article also describes the importance of multistakeholder collaboration and ongoing maintenance of standardization amidst continued evolution in the field.

The full abstract states, “The 1990s saw rapid growth in international activity in hematopoietic cell transplantation. As national donor registries were established and international collaboration increased, a need to transfer cellular therapy products across national borders emerged. A lack of international standards for identification, terminology and labeling resulted in significant challenges for import and export. Twenty years of effort by a large group of experts supported by professional societies and accreditation bodies has today achieved a high degree of standardization. This review highlights the main landmarks in this journey and serves as a reminder of the importance of taking the “long view” when working toward international standardization. It demonstrates the need for continual maintenance and enhancement of standards to meet the changing needs of the cell therapy industry and highlights recent developments in ISBT 128.”

FACT continues to support use of ISBT 128 coding and labeling, and appreciates ICCBBA’s ongoing efforts to accommodate emerging needs for standardization.

*Ashford, P. et al (2022). Standardization of cellular therapy terminology, coding and labeling: a review.” Cytotherapy. 24(6). 577-582.