Institute for Glycomics, Griffith University, Gold Coast, QLD, Australia.
Max Planck Unit for the Science of Pathogens, Berlin, Germany.
Adv Biochem Eng Biotechnol. 2021;175:413-434. doi: 10.1007/10_2020_144.
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 glycosylation-related 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.
糖基化是决定生物治疗药物药理特性的关键因素，包括其稳定性、溶解度、生物利用度、药代动力学和免疫原性。因此，全面了解生物治疗药物的糖基化对于证明相似性至关重要。监管机构还要求在生物类似物的开发、制造和放行过程中，广泛记录对与糖基化相关的关键质量属性（CQA）的全面分析。质谱技术极大地促进了生物治疗药物糖基化 CQA 的表征。在这里，我们提供了一个关于基于 MS 的生物技术产品特性相关技术的视角概述，重点介绍了最近的发展，这些发展允许确定糖基化特征，如糖基化位点、唾液酸连接、聚糖结构和含量。
