PDA Cryopreservation of Cells Standard Published with SCB’s Support
SCB, together with the Parenteral Drug Association (PDA), is pleased to announce the publication of a new regenerative medicine standard, PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing. This standard was one of the most rapid regenerative medicine standard efforts to date—spanning just three years from initiation to publication. The efficiency of its development showcases how coordination of the regenerative medicine community can accelerate the path to publication.
How the Standard Will Help the Regenerative Medicine Field
The standard offers best practices for establishing suitable procedures for cryopreservation of cells for use in regenerative medicine products. It provides an approach for choosing the right cryopreservation process, making decisions about process variables (e.g., freezing rates and thaw temperatures), and assessing the success of a cryopreservation process.
Who can benefit from this standard and how:
Cell therapy manufacturers will save time, money, energy, and effort on troubleshooting cryopreservation processes and be able to invest in products with shorter shelf lives.
Companies and suppliers that store cells will have a better understanding of effective practices to maximize quality and safety.
Healthcare providers will be more assured of product quality and safety after cryopreservation.
Researchers will be able to store cell therapy products more reliably for future use and study.
Patients will have broader access to new therapies, and may face fewer hurdles (e.g., travel to a distant clinic) for receiving needed treatments
“This standard addresses a critical need for best practices to improve confidence in the safety and functionality of cells after cryopreservation,” said SCB Senior Scientific Program Manager Dawn Henke. “It will help move the field forward by making cryopreservation a more affordable and accessible option to extend the life of cell therapy products.”
How the Standard Was Developed
PDA initiated this standard effort in February 2019 in response to stakeholder requests for guidance on cryopreservation best practices:
During the 2019 regenerative medicine standards workshop, co-hosted by FDA, NIST, SCB, and Nexight Group, which highlighted cryopreservation as a critical need, PDA and SCB identified the opportunity to partner on advancing the standard.
PDA then developed a diverse task force to draft the standard and called on SCB to coordinate a broader working group to offer targeted input into the standard and increase community engagement and awareness.
Next Steps
Promote Availability: SCB will make the community aware of the standard’s availability—particularly through the Regenerative Medicine Standards Portal—and help educate the community on implementation.
Continue Advancing Standards: Our work advancing standards to ensure the quality and safety of cell-based products is ongoing; we have an open working group related to determining and interpreting cell viability that is currently seeking expertise from regulators; bioprocessing professionals; cancer researchers; developers of assay kits, reagents, and equipment; and therapeutic product developers.
Get Involved
Contact SCB to join an SCB-coordinated standards project like the one discussed above or learn about other ways you can get involved in regenerative medicine standards development.
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