ISBT 128 Labeling Standard for Cells Collected for Cellular Therapy Manufacturing: Comments Due October 18th
Thanks to the teamwork of several stakeholders in apheresis cell collection, the field is one step closer toward label standardization. Comments are needed in the most recent draft ISBT 128 label published by ICCBBA by October 18, 2020.
As reported in previous Just the FACTs newsletters, a multi-stakeholder working group led by the Standards Coordinating Body and the Deloitte NextGen Industry Working Group, consisting of industry, registries, accrediting organizations, technology providers, and apheresis and quality subject matter experts, released a draft standard labeling proposal for collected cells.
Public comments following the release of that draft indicated support for ISBT 128 labeling for starting material intended for further manufacturing. After reviewing these comments, ICCBBA has released a draft Standard for Labeling of Collection Products for Cellular Therapy Manufacturing.
This Standard builds on existing ISBT 128 standards, including compatible label dimensions and essential traceability information, but also accommodates sponsor/manufacturer information. As stated by the ICCBBA website, “it is for use only in situations where the sponsor/manufacturer has adopted this standard and has provided the necessary information to populate the sponsor/manufacturer section of the label.” Although the standard was written with apheresis in mind, the label could be used on products collected from other sources and intended for further manufacturing.