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Considerations on CMC research and evaluation of anti-viral antibodies
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Wen-bo WANG, Wei WEI
Chinese Journal of New Drugs | 2023, 32(24) : 2501 - 2506
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Chinese Journal of New Drugs | 2023, 32(24): 2501-2506
Considerations on CMC research and evaluation of anti-viral antibodies
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Wen-bo WANG, Wei WEI
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2023-12-30
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Antibodies, as an important tool for treatment and prevention of viral infection, have been applied to the treatment and prophylaxis of viral infectious diseases. This article summarized the latest research progress in antibody products that target viruses, and discussed some quality assessment concerns in epitope mapping, neutralization spectrum evaluation, and quality control, expecting to promote the clinical transformation and application of such products.

anti-viral antibodies  /  pharmaceutical assessment  /  epitope and neutralization spectrum  /  quality research and control
Wen-bo WANG, Wei WEI. Considerations on CMC research and evaluation of anti-viral antibodies[J]. Chinese Journal of New Drugs, 2023 , 32 (24) : 2501 -2506 .
Year 2023 volume 32 Issue 24
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  • Online Date:2026-03-05
  • Published:2023-12-30
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  • Accepted:2023-11-13
Affiliations
    Center for Drug Evaluation, 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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