SCB Launches New Project to Update ISBT 128 Labeling Standard
The need for updated labeling standards specific to regenerative medicine was one of the high-priority standards needs identified by the community in Community Perspectives: Needed Standards in Regenerative Medicine. Recognizing the importance of this need, SCB has engaged with the community at various events to gauge interest and help coordinate activities around labeling standards.
The issues of labeling, chain of identity, and chain of custody was identified as a major area of need by experts at the Realizing the Benefit of 21st Century Cures through Standards Development workshop in March 2019. It was prioritized as an area where standards could have a dramatic impact. This was confirmed at other meetings of experts such as the Deloitte Next Generation Therapies Industry Working Group meeting in September 2019. The working group is made up of approximately 30 representatives from industry, academia, standards developing organizations (SDOs), and SCB to discuss labeling challenges, chain of identity/chain of custody issues, and digital platform standardization.
A key goal that emerged from the meeting was updating the current ICCBBA ISBT 128 standard to address labeling issues specific to apheresis products with intended use for regenerative medicine manufacturing. The global labeling standard, ISBT 128, is widely used for identification, labeling, tracking, and data transfer of medical products of human origin, including regenerative medicine products. However, since ISBT 128 was designed for one-way donations, this standard is often insufficient to meet the complex needs of regenerative medicine therapy manufacturing processes.
Regenerative medicine products pass between many different stakeholders—including manufacturers, transportation companies, and healthcare facilities—and may even return to the original donor in the case of autologous therapies. This process requires detailed and consistent tracking of information between different steps in the supply chain.
The industry working group invited SCB to coordinate the effort to update ISBT 128 due to our experience with standard advancement projects and our ability to provide nonbiased support. SCB is driving the effort forward by:
Expanding the initial group of experts to create a broader standard advancement working group with additional experts from the community
Coordinating industry experts, ICCBBA, clinical experts, and other stakeholders in drafting the standard
The draft standard, Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing, opened for public comment in February and will accept comments until April 24, 2020. The updated draft standard addresses the following topics:
Collection center identifiers
Receiving facility identifiers
Expiration dates and times
Clinical trial labels
Autologous use labeling
Related donor use
Electronic capture of additional critical information
Get Involved
If you would like to provide comments on the draft or are interested in getting involved in the standard advancement project working group, contact Dawn Henke (dhenke@regenmedscb.org).