Industry, ICCBBA, and FACT hear the calls from apheresis collection facilities to reduce variations in requirements for cellular starting material collection from different companies. One of the most obvious instances of variation that impact patient safety is labeling of the collected cells.
FACT requires full implementation of ISBT 128 coding and labeling. FACT also encourages accredited organizations to participate in clinical trials and provide advanced cellular therapies to their patients. Labels for clinical trial and commercial products are developed by the manufacturer (i.e., the clinical trial sponsor or the commercial manufacturer) and approved by the regulatory authority. Because compliance with Applicable Law is also required, accredited organizations must often use labels outside of ISBT 128. The risks are evident, and near-misses have been reported. Handwritten information, ambiguous identifiers, and variations in processes create risks of product mix-ups and incorrect product information.
Since 2020, FACT has been promoting the work of ICCBBA to develop an ISBT 128 label that will reduce manual transcription errors and promote chain of identity for cells that are collected for further manufacturing by an external entity. Furthermore, the use of ISBT 128 for these collections allows 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.
Following two rounds of public comment, ISBT 128 Standard Labeling of Collection Products for Further Manufacture (ICCBBA ST-018) was published in November 2020. This document is a supplement to the ISBT 128 Standard Technical Specification (ST001) and defines the labeling requirements for cellular therapy apheresis collection products for further processing by a clinical trials sponsor or a manufacturer. The Standard is for use in situations where the sponsor or manufacturer has adopted this Standard and has provided the necessary information to populate the relevant section of the label.
This new ISBT 128 label format, often referred to as a “split label” format, includes all information required by existing ISBT 128 requirements on the left side, and allows manufacturer-specific information on the right side. This format strikes an appropriate balance between internationally standardized information, in both eye- and machine-readable format, and the information individual companies require to maintain chain of identity and regulatory compliance.
The split ISBT 128 label for collected products for further manufacture meets FACT Standards. In fact, FACT prefers use of this label for these situations and is appreciative of the support industry has contributed to adapting their processes and regulatory filings to accommodate it. Companies seeking to adopt this standard acknowledge ISBT 128’s role in patient safety and efficiency in the cellular therapy product supply chain.
We recognize that this new ISBT 128 label format was published during the COVID pandemic, a time of high demand and workforce shortages for our accredited facilities who are still feeling the impacts. Although adopting this change will require additional effort, the long-term savings in patient safety and process efficiencies will pay off. FACT-accredited apheresis collection facilities are encouraged to review this Standard, work with their ISBT 128 vendors and Be the Match regarding implementation and validation, and inquire with clinical trial sponsors and manufacturers about their intentions for adopting it.
Cytotherapy Article Reviews Progress of ISBT 128 Labeling, Provides Example of Successful Standardization in Cellular Therapy
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.”
*Ashford, P. et al (2022). Standardization of cellular therapy terminology, coding and labeling: a review.” Cytotherapy. 24(6). 577-582. https://doi.org/10.1016/j.jcyt.2022.02.009