Project: Base Labeling Requirements for Apheresis Products for Regenerative Medicine Manufacturing
Type: Standards Advancement Project
Partners: ICCBBA and the SCB Cell Therapy Sector Working Group
Get Involved:Standard published: additional needs TBD
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Description:
Existing labeling standards for medical products of human origin were designed for simple, one-way donation processes. They do not account for the complexity of regenerative medicine therapy development, which may often involve dozens of companies with unique processing systems, technology differences, employee roles, or local languages. As a result, cell collection labels often vary among companies and facilities throughout the cell therapy supply chain. The need to produce many different labels can result in many varied and burdensome printing requirements for collection centers. Such complexity raises the risk of human error, potentially leading to delays with transferring products across the supply chain or safety risks for patients.
SCB organized a working group and worked with ICCBBA to update the current ISBT 128 standard to address labeling issues specific to apheresis products with intended use for regenerative medicine manufacturing. The standard addresses topics such as:
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
Progress:
(learn more about the standards advancement process)
Note: Projected start dates are estimates only. Development of a standard depends on SDO timelines, which can vary.
Assembled a Working Group: SCB expanded on an initial working group, inviting additional experts from the community to participate. The working group assessed the best focus areas for a labeling standard and identified potential barriers to feasibility, including expert availability and relevant feasibility factors such as technical and implementation feasibility.
Provided Drafting Support: SCB coordinated with the working group, ICCBBA, and other stakeholders as they drafted an update to the current ISBT 128 labeling standard. The draft standard was opened for public comment in February 2020 and underwent revisions based on community feedback.
Published: The standard was published as ST-018 ISBT-128, Standard Labeling of Collection Products for Cellular Therapy and is available at no cost from ICCBBA.
Get Engaged:
To learn more about this initiative, please contact SCB.