Most recent
ANSI/PDA Standard 02-2021
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 purpose of this document is to provide 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. This document 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 guide emphasizes the effect cryopreservation and recovery may have on cell viability and cell function. Although best practices for users in cell-based product manufacturing are discussed, specific procedures will likely depend on the nature of the biological cells being cryopreserved.
Parenteral Drug Association [pda]