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Glycosylation analysis of therapeutic proteins
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Hong WANG1, Hong-rui YIN1, Yi-le CHEN2, Xin-xin FANG1, Ming-ming XU1, Cheng TIAN2, Jin XU3, Gang CHEN1, Hong SHAO1, *
Acta Pharmaceutica Sinica | 2021, 56(10) : 2779 - 2786
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Acta Pharmaceutica Sinica | 2021, 56(10): 2779-2786
• Reviews •
Glycosylation analysis of therapeutic proteins
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Hong WANG1, Hong-rui YIN1, Yi-le CHEN2, Xin-xin FANG1, Ming-ming XU1, Cheng TIAN2, Jin XU3, Gang CHEN1, Hong SHAO1, *
Affiliations
  • 1. Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China
  • 2. Analytical Sciences, WuXi Biologics (Shanghai) Co., Ltd., Shanghai 200131, China
  • 3. State Key Laboratory of Antibody Medicine and Targeted Therapy, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai Zhangjiang Biotechnology Co., Ltd., Shanghai 201203, China
Published: 2021-10-12 doi: 10.16438/j.0513-4870.2021-0579
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As one of the most critical post-translational modifications, glycosylation of therapeutic proteins has a profound impact on their safety, efficacy and consistent. However, glycosylation is not a template-driven process, therefore variability in the glycosylation pattern of a protein can arise. This makes challenges of glycan analysis and control. Here, we review the overall control strategy, basic requirements for standardized protocols and the novel technologies of glycosylation analysis to accelerate the development of therapeutic glycoproteins.

therapeutic glycoprotein  /  glycosylation analysis  /  overall control strategy
Hong WANG, Hong-rui YIN, Yi-le CHEN, Xin-xin FANG, Ming-ming XU, Cheng TIAN, Jin XU, Gang CHEN, Hong SHAO. Glycosylation analysis of therapeutic proteins[J]. Acta Pharmaceutica Sinica, 2021 , 56 (10) : 2779 -2786 . DOI: 10.16438/j.0513-4870.2021-0579
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Article Info
doi: 10.16438/j.0513-4870.2021-0579
  • Receive Date：2021-04-17
  • Online Date：2025-12-18
  • Published：2021-10-12
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History
  • Received：2021-04-17
  • Revised：2021-07-15
Funding
Affiliations
    1. Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China
    2. Analytical Sciences, WuXi Biologics (Shanghai) Co., Ltd., Shanghai 200131, China
    3. State Key Laboratory of Antibody Medicine and Targeted Therapy, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai Zhangjiang Biotechnology Co., Ltd., Shanghai 201203, China
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表12种不同金属材料的力学参数
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Family		 属数
Number of
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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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