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Research progress on quality control analysis methods for stem cell products
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Ying YANG, Chun-ming RAO**
Chinese Journal of Pharmaceutical Analysis | 2025, 45(1) : 4 - 11
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Chinese Journal of Pharmaceutical Analysis | 2025, 45(1): 4-11
Special Column for Quality Research and Evaluation of Stem Cell Products
Research progress on quality control analysis methods for stem cell products
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Ying YANG, Chun-ming RAO**
Affiliations
  • JOINN Pharmaceutical Quality Research and Testing (Beijing) Co, Ltd, Beijing 102605,China
Published: 2025-01-31 doi: 10.16155/j.0254-1793.2024-1299
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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.

stem cells products  /  quality control  /  quality standards  /  analytical methods  /  safety  /  biological effectiveness
Ying YANG, Chun-ming RAO. Research progress on quality control analysis methods for stem cell products[J]. Chinese Journal of Pharmaceutical Analysis, 2025 , 45 (1) : 4 -11 . DOI: 10.16155/j.0254-1793.2024-1299
Year 2025 volume 45 Issue 1
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doi: 10.16155/j.0254-1793.2024-1299
  • Receive Date:2024-12-02
  • Online Date:2026-03-19
  • Published:2025-01-31
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  • Received:2024-12-02
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    JOINN Pharmaceutical Quality Research and Testing (Beijing) Co, Ltd, Beijing 102605,China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
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占总种数比例
Percentage of
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种数
Number of
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占总种数比例
Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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