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The concerns of CMC research and evaluation of antibody radionuclide conjugates products
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Xue WANG, Qian LI, Wei WEI
Chinese Journal of New Drugs | 2023, 32(2) : 143 - 147
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Chinese Journal of New Drugs | 2023, 32(2): 143-147
The concerns of CMC research and evaluation of antibody radionuclide conjugates products
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Xue WANG, Qian LI, Wei WEI
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2023-01-30
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Antibody radionuclide conjugates (ARC) conjugate radionuclides and antibodies through a linker and chelator, which can perform different functions of diagnosis or treatment. To date, ARC is an important product type of radionuclide drug conjugates (RDC), and there are many approved drugs and drug candidates in clinical trials. However, the domestic industry faces many challenges in the development of clinical application-grade ARC products. This article summarizes the latest research progress of ARC products, from raw materials, production process and quality control, expecting to promote the clinical transformation and application of such products.

antibody radionuclide conjugates  /  CMC research  /  evaluation  /  concerns
Xue WANG, Qian LI, Wei WEI. The concerns of CMC research and evaluation of antibody radionuclide conjugates products[J]. Chinese Journal of New Drugs, 2023 , 32 (2) : 143 -147 .
Year 2023 volume 32 Issue 2
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  • Online Date:2026-03-05
  • Published:2023-01-30
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  • Accepted:2022-11-14
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
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Number of
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种数
Number of
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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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