Two New SCB-Coordinated Standards Published
SCB is pleased to announce that two of our coordinated projects have recently resulted in published standards:
ISO 23033:2021, General Requirements and Considerations for the Testing and Characterization of Cellular Therapeutic Products
ISO/TS 23565:2021, General Requirements and Considerations for Equipment Systems used in the Manufacturing of Cells for Therapeutic Use
1) Characterization of Human Cells for Therapeutic Use Standard
Cell characterization encompasses the assessment of characterization of cells for therapeutic use. This standard focuses on validating and determining fit-for purpose assays such as cell identity, purity, biological activity, and viability, among other key cell attributes. Cell characterization is critical to product development in all regenerative medicine sectors.
The newly published standard will help product developers more easily decide which assays to use for cell characterization and give regulators greater confidence in the decision-making processes of regenerative medicine product developers.
Learn more: Read our spotlight feature on the efforts of this working group, published earlier in 2021.
2) Cell Therapy Manufacturing Equipment Standard
The manufacturing equipment for regenerative medicine products often varies in ways that make it difficult to evaluate and ensure consistent product quality and safety.
The newly published standard provides minimum requirements and general considerations for equipment involved in cell isolation and selection, expansion, washing and volume reduction, cell finishing, cryopreservation, and storage. The standard will allow product developers to better assess the impact of manufacturing changes or innovations on their products and will enable cross-comparison of products developed in different locations or by different companies.
Learn more: The project summary provides more detail about all the steps that were involved in advancing this standard effort.
SCB Helps Accelerate Standards Advancement
Altogether, nine new regenerative medicine standards have been published with SCB support since our launch in late 2017. These results illustrate the success of our standards advancement process, which aims to accelerate the availability of standards that will have the greatest benefit to the field:
Gather input from the community to determine the highest priority standards needs
Bring together experts to assess the feasibility of developing standards for the high-priority need areas
Assemble working groups to move forward with the high-priority need areas that have sufficient technical foundation and community support for successful standard development
Present potential standards to standards developing organizations (SDOs) for development, working closely with multiple SDOs to prevent overlap and harmonize related standards
Maintain momentum for the standard efforts as they move through the development process by coordinating and supporting the working groups drafting the standard
Raise awareness of new standards once they are published
Stay Current with the Regenerative Medicine Standards Portal
Learn about current standards activity, including newly published and revised standards and opportunities to participate in standards development, by visiting the SCB Regenerative Medicine Standards Portal. Frequent updates ensure that you have access to the most current information.
Get Involved
Contact SCB to join an SCB-coordinated standards project like the two discussed above or learn about other ways you can get involved in regenerative medicine standards development.
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