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ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing (single user digital version)

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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

This new 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.

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. It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products. However, it can provide general guidance during the assessment of regulatory requirements.

The best practices and guidance details outlined in the document provide general procedural support for cryopreservation of cell-based products during both early and late phases of product development.

This document is a current best practice standard and guide on how to establish suitable conditions for the cryopreservation and recovery of cells, cell lines, and cell-based products for use in cell and gene therapies and regenerative medicine manufacturing.

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Table of Contents:

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  • Introduction
  • Scope
  • Normative references
  • Terms and definitions
  • Acronyms
  • Critical Quality Attributes of the Cell-based Product
  • Cryopreservation Process Steps and Critical Process Parameters
  • Cell Characterization and Testing
  • Formulation Development
  • Cryogenic Container Closure Systems
  • Cryopreservation Procedures
  • Cryogenic Storage and Transport
  • Thawing
  • Bibliography/References
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