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

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, 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

Progress:

Chart of project phases, steps, and anticipated completion dates

Note: Projected 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 has supported NIST in the development of the draft standard (ISO/CD 23033-Cell Characterization-General guide for characterization of human cells for therapeutic applications), as well as review of relevant cell characterization terminology.

Providing Drafting Support: The draft standard was discussed at the December 2018 ISO meeting and the revised version is open for committee draft (CD) ballot until April 2019. SCB will continue to provide support to ISO/TC 276 WG3 as the draft moves through the ISO standard development process.

Get Engaged:

SCB needs subject matter experts like you to review and contribute to the draft. To help, please contact SCB.