干细胞产品质量研究与检测专栏

干细胞产品质量控制分析方法研究进展*

  • 杨英 ,
  • 饶春明
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  • 北京昭衍药物检定研究有限公司,北京 102605
第一作者 Tel:(010)67869966;E-mail:yangying@joinn-lab.com
**Tel:(010)67869966;E-mail:raochunming@joinn-lab.com

收稿日期: 2024-12-02

  网络出版日期: 2025-05-29

基金资助

*北京市科技计划课题:基因修饰免疫细胞和基因治疗药物质量控制关键技术与服务平台建设(Z221100007922015)

Research progress on quality control analysis methods for stem cell products*

  • YANG Ying ,
  • RAO Chun-ming
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  • JOINN Pharmaceutical Quality Research and Testing (Beijing) Co., Ltd., Beijing 102605, China

Received date: 2024-12-02

  Online published: 2025-05-29

摘要

干细胞是一类具有不同程度增殖、自我更新和分化潜能的细胞,在再生医学和多种疾病治疗领域有重要作用。建立干细胞产品的质量控制方法和质量标准是保证产品安全、有效的重要条件。本文综述了干细胞产品质量控制的相关法规和指南,并对干细胞的基本生物学特性、微生物学安全性、生物学安全性、生物学有效性和其他常规检测项目的检测方法和质量研究方法进行了概述,进一步拓展至基因修饰的干细胞产品及干细胞来源的功能细胞和外泌体的质量研究方法。

本文引用格式

杨英 , 饶春明 . 干细胞产品质量控制分析方法研究进展*[J]. 药物分析杂志, 2025 , 45(1) : 4 -11 . DOI: 10.16155/j.0254-1793.2024-1299

Abstract

Stem cells have varying degrees of proliferation, self-renewal, and differentiation potential, and can be applied in regenerative medicine and the treatment of various diseases. To ensure safety and effectiveness of stem cell products, it is important to establish quality control methods and standards. Herein, we review the regulations and guidelines for stem cell products, and provide an overview of the detection assays on the basic biological characteristics, microbiological safety, biological safety, biological effectiveness and other conventional testing methods and quality research methods for stem cells. We further describe the quality research methods for genetically modified stem cell products, functional cells derived from stem cells, and extracellular vesicles, etc.

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