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
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, as well as greater predictability of the impacts of processing changes throughout the manufacturing process on the final product. Developing standards for this 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 is coordinating 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.
Anticipated Availability: November 2020
Convened Experts: SCB formed a working group to assist with drafting this standard.
Supported Draft Development: SCB has supported NIST in the development of the draft standard (ISO/CD 23033: General guidelines for the characterization and testing of cellular therapeutic products), as well as review of relevant cell characterization terminology.
Providing Drafting Support: Comments received during committee draft (CD) ballot were discussed at the June 2019 ISO/TC 276 meeting. The standard will be revised and is expected to be submitted for Draft International Standard (DIS) ballot in December. SCB will continue to provide support to ISO/TC 276 WG3 as the draft moves through the ISO standard development process.
SCB needs subject matter experts like you to review and contribute to the draft. To help, please contact SCB.