ANSI/PDA Standard on Cryopreservation of Cells for Cell and Gene Therapies Receives Complete Recognition Status by U.S. FDA CBER 25 March, 2024

PDA today proudly announced at its 2024 Annual Meeting in Long Beach, Calif., ANSI/PDA 02-2021 Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing has been included in a listing of recognized standards for regenerative medicine therapies by the U.S. FDA Center for Biologics Evaluation and Research. FDA released the list following the publication of "Guidance for Industry: Voluntary Consensus Standards Recognitions Program for Regenerative Medicine Therapies" in October 2023.

ANSI/PDA 02-2021 received the status of "Complete Recognition," a designation meaning the entire content of the standard is recognized. This is the first standard published by ANSI/PDA recognized by FDA since PDA became an ANSI-accredited standards developer in 2017.

FDA's recognition of ANSI/PDA 02-2021 represents an important milestone for PDA and our standards-setting program.

Post this "FDA's recognition of ANSI/PDA 02-2021 represents an important milestone for PDA and our standards-setting program," said Glenn Wright, PDA President & CEO. "We cannot thank the teams of experts enough that work diligently with PDA's staff to bring these standards to fruition, and recognition by FDA further demonstrates the scientific and technical value of their work."

The full title of ANSI/PDA Standard 02-2021 is: "Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing: An Introduction and Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue Products." The standard provides guidance on how to establish suitable procedures for the cryopreservation and recovery of biological cells for use in cell and gene therapy products and regenerative medicine manufacturing either as an intermediate step or when cryopreservation is the final step. It presents cryopreservation as a modular process and describes key details that should be considered when developing a cryopreservation and recovery process for a specific use-case.

The standard is available at PDA's Bookstore.

PDA has submitted additional ANSI/PDA standards to FDA for consideration under the standards recognition program.

The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information. PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers high-quality, relevant education to the industry. Since its founding in 1946 as a nonprofit organization, PDA has been committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical/biopharmaceutical manufacturing science and regulation, so members can better serve patients.