Project: Ancillary Materials Used in Cellular Therapy Production

TYPE: Standards Advancement Project

PARTNERS: ISO / TC 276 U.S. Working Group 4 (US WG4) and the SCB Cell Therapy and Tissue Engineering Sector Working Groups

DESCRIPTION:

While ancillary materials (AM)—including growth factors, nutrients, reagents, and other raw materials—are a critical part of the cell therapy manufacturing process, they may have unintended impacts on the safety and effectiveness of a final product. Appropriate standardization of AMs and their accompanying documentation will help both AM suppliers and users ensure lot-to-lot consistency of AM characteristics and quality attributes, facilitate faster product development and regulatory approval, and improve the reliability and performance of final products.

In March 2016, ISO / TC 276 US WG4 prioritized the new project ballot for a three-part series of documentary standards on ancillary materials (ISO/TS 20399: Ancillary materials present during the production of cellular therapeutic products):

• Part 1: General Guidelines and Definitions

• Part 2: Best Practice Guidance for Ancillary Material Suppliers

• Part 3: Best Practice Guidance for Ancillary Material Users

SCB helped coordinate the drafting of these standards and is now coordinating the U.S. effort to combine this three-part ISO documentary standard on AM into a single document for publication as an international standard.

PROGRESS:

(learn more about the standards advancement process)

Supported Draft Development: SCB coordinated the drafting of Part 2 and provided expert input on the other two installments. The three-part standard was published in November 2018 and is now available for purchase.

Combining and Elevating the Series to an International Standard: SCB is coordinating the effort to combine the three-part series into a single document for publication as an international standard (ISO/DIS 20399). The document was submitted for a new work item (NP) ballot in October 2019 and was accepted as an official work item. The standard entered the final voting stage in June 2021 and is expected to be published in early 2023.

GET ENGAGED:

To learn more about this initiative, please contact SCB.