Oh Myung Jin, Hua Serenus, Kim Unyong, Kim Hyun Joong, Lee Jua, Kim Jae-Han, An Hyun Joo
Graduate School of Analytical Science & Technology, Chungnam National University, Daejeon, Korea.
Asia Glycomics Reference Site, Daejeon, Korea.
Bioanalysis. 2016 Apr;8(7):711-27. doi: 10.4155/bio.16.20. Epub 2016 Mar 11.
Glycosylation plays an important role in ensuring the proper structure and function of most biotherapeutic proteins. Even small changes in glycan composition, structure, or location can have a drastic impact on drug safety and efficacy. Recently, glycosylation has become the subject of increased focus as biopharmaceutical companies rush to create not only biosimilars, but also biobetters based on existing biotherapeutic proteins. Against this backdrop of ongoing biopharmaceutical innovation, updated methods for accurate and detailed analysis of protein glycosylation are critical for biopharmaceutical companies and government regulatory agencies alike. This review summarizes current methods of characterizing biopharmaceutical glycosylation, including compositional mass profiling, isomer-specific profiling and structural elucidation by MS and hyphenated techniques.
糖基化在确保大多数生物治疗蛋白的正确结构和功能方面发挥着重要作用。即使聚糖组成、结构或位置的微小变化也会对药物安全性和疗效产生巨大影响。近年来，随着生物制药公司不仅急于生产生物仿制药，还基于现有的生物治疗蛋白开发更优生物药，糖基化已成为越来越受关注的主题。在这种持续的生物制药创新背景下，更新后的准确详细分析蛋白质糖基化的方法对生物制药公司和政府监管机构都至关重要。本综述总结了目前表征生物制药糖基化的方法，包括组成性质量分析、异构体特异性分析以及通过质谱和联用技术进行结构解析。
