Glycoproteomics Technologies in Glycobiotechnology
Glycoproteomics Technologies in Glycobiotechnology
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DOI：
10.1007/10_2020_144
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发表时间：
2021-01-01
期刊：
影响因子：
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通讯作者：
Kolarich, Daniel
中科院分区：
文献类型：
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作者：
Alagesan, Kathirvel;Hoffmann, Marcus;Kolarich, Daniel
糖基化是决定生物治疗药物药理性质的关键因素，包括其稳定性、溶解性、生物利用度、药代动力学和免疫原性。因此，有关生物治疗药物糖基化的全面信息对于证明相似性至关重要。监管机构还要求在生物仿制药的开发、制造和释放过程中，对糖基化相关的关键质量属性(CQA)进行广泛的综合分析。质谱学在生物治疗的糖基化CQA表征方面已经催化了巨大的进步。在这里，我们提供了与生物治疗产品表征相关的基于MS的技术的透视性概述，重点介绍了允许确定糖基化特征的最新进展，例如糖基化位点、唾液酸键、多糖结构和含量。
Glycosylation is a key factor determining the pharmacological properties of biotherapeutics, including their stability, solubility, bioavailability, pharmacokinetics, and immunogenicity. As such, comprehensive information about glycosylation of biotherapeutics is critical to demonstrate similarity. Regulatory agencies also require extensive documentation of the comprehensive analyses of glycosylationrelated critical quality attributes (CQAs) during the development, manufacturing, and release of biosimilars. Mass spectrometry has catalysed tremendous advancements in the characterisation of glycosylation CQAs of biotherapeutics. Here we provide a perspective overview on the MS-based technologies relevant for biotherapeutic product characterisation with an emphasis on the recent developments that allow determination of glycosylation features such as site of glycosylation, sialic acid linkage, glycan structure, and content.