This new standard provides guidance on how to establish suitable procedures \r\nfor the cryopreservation and recovery of biological cells for use in cell and \r\ngene therapy products and regenerative medicine manufacturing either as an \r\nintermediate step or when cryopreservation is the final step. The guide \r\nemphasizes the effect cryopreservation and recovery may have on cell viability \r\nand cell function and can provide general guidance during the assessment of \r\nregulatory requirements. The best practices and guidance details outlined in the \r\ndocument provide general procedural support for cryopreservation of cell-based \r\nproducts during both early and late phases of product \r\ndevelopment.

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.

Available to download
\r\nFormat: PDF (1 file 459 KB)

Click here to view the digital downloading instruction and Terms of Usage

Table of Contents:

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

This new standard provides guidance on how to establish suitable procedures \r\nfor the cryopreservation and recovery of biological cells for use in cell and \r\ngene therapy products and regenerative medicine manufacturing either as an \r\nintermediate step or when cryopreservation is the final step. The guide \r\nemphasizes the effect cryopreservation and recovery may have on cell viability \r\nand cell function and can provide general guidance during the assessment of \r\nregulatory requirements. The best practices and guidance details outlined in the \r\ndocument provide general procedural support for cryopreservation of cell-based \r\nproducts during both early and late phases of product \r\ndevelopment.

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.

Available to download
\r\nFormat: PDF (1 file 459 KB)

Click here to view the digital downloading instruction and Terms of Usage

Table of Contents:

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

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ANSI/PDA标准02-2021：用于细胞疗法，基因疗法和再生医学制造的细胞冷冻保存（单用户数字版）

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ANSI/PDA标准02-2021：用于细胞疗法，基因疗法和再生医学制造的细胞的冷冻保存：关于如何制备，冷冻液和恢复细胞，细胞系和基于细胞的组织的引言和最佳实践方法产品

该新标准提供了有关如何建立合适的程序，用于在细胞和基因疗法产品中使用和恢复生物细胞的合适程序，并在基因治疗产品和再生医学制造中作为中级步骤，或者当冷冻保存是最后一步时。

本文档将冷冻保存作为模块化过程，并描述为特定用例开发冷冻保存和恢复过程时应考虑的关键细节。

该指南强调了冷冻保存和恢复对细胞活力和细胞功能的影响。它不打算提供有关与基于细胞的产品直接相关的条款和程序的信息。但是，它可以在评估监管要求期间提供一般指导。

文档中概述的最佳实践和指导细节为产品开发的早期和晚期阶段的基于细胞产品的冷冻保存提供了一般的程序支持。

该文档是当前的最佳实践标准，并指导了如何建立适当的条件，以用于细胞，细胞系和基于细胞的细胞产品，用于细胞和基因疗法以及再生医学制造。

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• 介绍
• 范围
• 规范参考
• 术语和定义
• 首字母缩写
• 基于细胞的产品的关键质量属性
• 冷冻保存过程步骤和关键过程参数
• 细胞表征和测试
• 配方开发
• 低温容器关闭系统
• 冷冻保存程序
• 低温存储和运输
• 解冻
• 参考书目/参考

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• 出版日期：2022年1月
• ISBN编号：
• 页数：26
• PDA项目号：60003

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