SCB Perspectives: ISO Publishes Three-Part Documentary Standard on Ancillary Materials for Cell Manufacturing Processes

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Claudia Zylberberg, SCB Board Member, Akron Biotech

December 17, 2018

I’m pleased to announce that one of the first standards advancement projects SCB was involved in, Ancillary Materials Used in Cellular Therapy Production, has culminated in the publication of a three-part documentary ISO standard (ISO/TS 20399):

Ancillary materials include secondary components such as growth factors, nutrients, and reagents that are used during the cell therapy manufacturing process. While these materials aren’t intended to be part of the final product, the residual amounts that remain after their use can impact the product’s quality and lot-to-lot consistency. Because of this, standards for ancillary materials are critical for ensuring effective and reliable cell therapy products.

Standards such as this one will not only help to improve product quality, but also bring cumulative benefits for stakeholders throughout the regenerative medicine ecosystem. Standardizing the quality and selection criteria for ancillary materials reduces the burden on regulators, speeding the regulatory approval process. This ultimately allows faster speed to market for new cell therapy products and helps patients to receive life-saving treatments sooner.

While the need for standards for ancillary materials was identified in late 2014, SCB joined the effort in mid-2016 to offer coordination and support. We coordinated a working group in the drafting of the second part of the standard aimed at ancillary material suppliers and providing expert input on Parts 1 and 3. Currently, SCB is helping to coordinate combining the three-part technical specification and elevating it to an international standard. SCB’s efforts were spearheaded by Sheng Lin-Gibson (NIST), Jiwen Zhang (Tmunity Therapeutics and SCB President), and myself, working in partnership with stakeholders from across the regenerative medicine community.

As we look ahead to the future adoption of this standard, I would like to thank everyone who participated in bringing this project to fruition. The engagement, support, and varied perspectives from members of the regenerative community are critical to the success of our standards advancement projects. Your efforts help to accelerate the standards development process and enhance the safety and effectiveness of emerging therapies.

If you would like to become involved in any of our ongoing standards advancement projects, we are always looking for expert input and feedback. To learn more, please contact SCB’s Senior Technical Program Manager Dawn Henke (