汪泓, 尹红锐, 陈益乐, 方欣欣, 徐明明, 田橙, 徐进, 陈钢, 邵泓. 治疗类糖蛋白的糖基化分析J. 药学学报, 2021,56(10): 2779-2786. doi: 10.16438/j.0513-4870.2021-0579
引用本文: 汪泓, 尹红锐, 陈益乐, 方欣欣, 徐明明, 田橙, 徐进, 陈钢, 邵泓. 治疗类糖蛋白的糖基化分析J. 药学学报, 2021,56(10): 2779-2786. doi: 10.16438/j.0513-4870.2021-0579
WANG Hong, YIN Hong-rui, CHEN Yi-le, FANG Xin-xin, XU Ming-ming, TIAN Cheng, XU Jin, CHEN Gang, SHAO Hong. Glycosylation analysis of therapeutic proteinsJ. Acta Pharmaceutica Sinica, 2021,56(10): 2779-2786. doi: 10.16438/j.0513-4870.2021-0579
Citation: WANG Hong, YIN Hong-rui, CHEN Yi-le, FANG Xin-xin, XU Ming-ming, TIAN Cheng, XU Jin, CHEN Gang, SHAO Hong. Glycosylation analysis of therapeutic proteinsJ. Acta Pharmaceutica Sinica, 2021,56(10): 2779-2786. doi: 10.16438/j.0513-4870.2021-0579

治疗类糖蛋白的糖基化分析

Glycosylation analysis of therapeutic proteins

  • 摘要: 糖基化作为至关重要的一种蛋白质翻译后修饰,在治疗类糖蛋白的安全性、有效性、质量可控性中起到关键性作用。然而,糖基化为非模板依赖性的酶促修饰,具有天然的异质性,使得糖基化的分析成为治疗类糖蛋白表征及质控的一个挑战。为了推动治疗类糖蛋白的技术法规建立及质控水平提高,本文从治疗类糖蛋白糖基化分析的核心理念、分析策略、良好分析的实施以及技术趋势4个方面进行深入探讨,力图为我国工业界治疗类糖蛋白糖基化分析提供参考,推动我国糖蛋白类生物医药产业的发展。

     

    Abstract: 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.

     

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