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Considerations on CMC evaluation of human-derived stem cell products
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Dong-mei HAN, Wu HE, Wei WEI, Kai-kun WEI
Chinese Journal of New Drugs | 2023, 32(2) : 148 - 153
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Chinese Journal of New Drugs | 2023, 32(2): 148-153
Considerations on CMC evaluation of human-derived stem cell products
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Dong-mei HAN, Wu HE, Wei WEI, Kai-kun WEI
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2023-01-30
Outline
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Stem cells have the potential of self-renewing and multilineage differentiation. Different types of stem cells have different advantages and limitations. It has become a hot topic of basic research and clinical application. Currently human-derived stem cell products to be developed as drugs come mainly from adult stem cells, embryonic stem cells, and induced pluripotent stem cells. Human-derived stem cell products are complex and diverse, showing unique therapeutic advantages in the treatment of a variety of diseases. This paper summarizes the characteristics and the latest research progress of human-derived stem cell products. According to the drug development and evaluation rules, this article brings up some quality assessment concerns and discussions in the major fields, such as raw materials, manufacturing process, quality research and control, stability, packaging container system, for the industry and regulators to discuss and communicate, expecting to promote the clinical transformation and application of this class of products.

stem cells  /  human-derived stem cell products  /  pharmaceutical assessment  /  quality research and control
Dong-mei HAN, Wu HE, Wei WEI, Kai-kun WEI. Considerations on CMC evaluation of human-derived stem cell products[J]. Chinese Journal of New Drugs, 2023 , 32 (2) : 148 -153 .
Year 2023 volume 32 Issue 2
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  • Online Date:2026-03-05
  • Published:2023-01-30
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History
  • Accepted:2022-12-26
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, 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
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
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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