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Quality control and evaluation concerns of recombinant glycoprotein hormones: "macro" and "micro" heterogeneity of glycosylation modifications
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Yi-jun LI, Ying-ying HU, Wei WEI
Chinese Journal of New Drugs | 2023, 32(24) : 2467 - 2476
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Chinese Journal of New Drugs | 2023, 32(24): 2467-2476
Quality control and evaluation concerns of recombinant glycoprotein hormones: "macro" and "micro" heterogeneity of glycosylation modifications
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Yi-jun LI, Ying-ying HU, Wei WEI
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2023-12-30
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Glycoprotein hormones, including follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, and thyroid stimulating hormone, are heterodimers consisting of non-convalently bound α and β subunits. Glycosylation complexity and structural heterogeneity are the focus of structural characterization and quality control of glycoprotein hormones. The modification sites, modification types, and sialic acid content of glycosylation are closely related to the receptor binding, signaling, biological function, and clearance rate of glycoprotein hormones in the body. In this paper, we summarize the marketed products of recombinant glycoprotein hormones, analyze the "macro" and "micro" complexity of glycosylation modification of these drugs, clarify the relationship between structural heterogeneity and biological function, sort out the analytical techniques used for structural confirmation and glycan chain identification, and put forward the relevant considerations of R&D pathway and CMC research based on their quality control difficulties.

glycoprotein hormone  /  follicle-stimulating hormone  /  glycosylation modification  /  biological potency  /  quality control
Yi-jun LI, Ying-ying HU, Wei WEI. Quality control and evaluation concerns of recombinant glycoprotein hormones: "macro" and "micro" heterogeneity of glycosylation modifications[J]. Chinese Journal of New Drugs, 2023 , 32 (24) : 2467 -2476 .
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  • Online Date：2026-03-05
  • Published：2023-12-30
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History
  • Accepted：2023-12-04
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
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
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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