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A brief analysis of the focus of production capacity research of autologous CAR-T therapeutic products
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Xue WANG1, Yan-song MA2, Wei WEI1, Wu HE1
Chinese Journal of New Drugs | 2023, 32(24) : 2447 - 2451
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Chinese Journal of New Drugs | 2023, 32(24): 2447-2451
A brief analysis of the focus of production capacity research of autologous CAR-T therapeutic products
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Xue WANG1, Yan-song MA2, Wei WEI1, Wu HE1
Affiliations
  • 1Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
  • 2Center for Food and Drug Inspection, National Medical Products Administration, Beijing 100076, China
Published: 2023-12-30
Outline
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Autologous chimeric antigen receptor T cell (CAR-T) cell therapy products have brought significant survival benefits to tumor patients, especially in the treatment of hematologic tumors. However, the common production mode of autologous CAR-T therapy products is complicated and has a long cycle. As a result, the production capacity of this kind of products has limited their clinical application to a certain extent. In this paper, based on the analysis of the common production mode of autologous CAR-T cell products, the content and evaluation of the capacity confirmation study and capacity change study of autologous CAR-T therapeutic products are proposed in combination with the current research progress, hoping to effectively promote the development and clinical application of such products.

autologous CAR-T cells  /  production capacity research  /  review considerations
Xue WANG, Yan-song MA, Wei WEI, Wu HE. A brief analysis of the focus of production capacity research of autologous CAR-T therapeutic products[J]. Chinese Journal of New Drugs, 2023 , 32 (24) : 2447 -2451 .
Year 2023 volume 32 Issue 24
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Article Info
  • Online Date:2026-03-05
  • Published:2023-12-30
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History
  • Accepted:2023-11-23
Affiliations
    1Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
    2Center for Food and Drug Inspection, National Medical Products Administration, Beijing 100076, 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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