Project: Characterization of Human Cells for Therapeutic Use
Type: Standards Advancement Project
Partners: ISO / TC 276 U.S. Working Group 3 (US WG3), National Institute of Standards and Technology (NIST), and the SCB Cell Therapy and Tissue EnGineering Sector Working Groups
Get Involved:Standard published: additional needs TBD
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Description:
The manufacturing of cell therapy products requires a complex mix of not only living cells but also active or inactive media and ancillary materials. Assessing and characterizing the key quality attributes—identity, purity, biological activity, and viability—of all aspects of a cell preparation can offer greater insight into how these components will interact. This characterization also enables greater predictability of the impacts of processing changes throughout the manufacturing process on the final product. Developing standards for characterization will allow product developers to create analytical tools optimized for assessing cell quality and consistency, thereby ensuring the safety and efficacy of cell therapy products.
SCB coordinated U.S. efforts to develop an ISO documentary standard on the characterization of cell therapy products that defines relevant cell characterization terms, processes to define critical quality attributes, and approaches to select and design fit-for-purpose measurements.
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.
Convened Experts: SCB formed a working group to assist with drafting this standard.
Supported Draft Development: SCB supported NIST in the development of the draft standard (ISO 23033: General requirements and considerations for the testing and characterization of cellular therapeutic products), as well as review of relevant cell characterization terminology. Comments received during committee draft (CD) ballot were discussed at the June 2019 ISO/TC 276 meeting. The standard was revised and submitted for Draft International Standard (DIS) ballot in February 2020 and started Final Draft International Standard (FDIS) in March 2021.
Finalized Draft: The standard was published in August 2021.
Get Engaged:
To learn more about this initiative, please contact SCB.