{"title":"MS-Based Glycome Characterization of Biotherapeutics With N- and O-Glycosylation.","authors":"Myung Jin Oh, Youngsuk Seo, Nari Seo, Hyun Joo An","doi":"10.1002/mas.21925","DOIUrl":null,"url":null,"abstract":"<p><p>With the increasing FDA approvals of glycoprotein-based biotherapeutics including monoclonal antibodies, cytokines, and enzyme treatments, the significance of glycosylation in modulating drug efficacy and safety becomes central. This review highlights the crucial role of mass spectrometry (MS) in elucidating the glycome of biotherapeutics that feature N- and O-glycosylation, directly addressing the challenges posed by glycosylation complexity and heterogeneity. We have detailed the advancements and application of MS technologies including MALDI-TOF MS, LC-MS, and tandem MS in the precise characterization of glycoprotein therapeutics. Emphasizing MS-based strategies for detecting immunogenic glycans and ensuring batch-to-batch consistency, this review highlights targeted approaches for glycoprotein, glycopeptide, and glycan analysis tailored to meet the stringent analytical and regulatory demands of biopharmaceutical development.</p>","PeriodicalId":206,"journal":{"name":"Mass Spectrometry Reviews","volume":" ","pages":""},"PeriodicalIF":6.9000,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Mass Spectrometry Reviews","FirstCategoryId":"92","ListUrlMain":"https://doi.org/10.1002/mas.21925","RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SPECTROSCOPY","Score":null,"Total":0}
引用次数: 0
摘要
随着越来越多基于糖蛋白的生物治疗药物（包括单克隆抗体、细胞因子和酶疗法）获得美国食品与药物管理局（FDA）的批准，糖基化在调节药物疗效和安全性方面的意义变得至关重要。本综述强调了质谱（MS）在阐明以 N- 和 O- 糖基化为特征的生物治疗药物的糖基化结果中的关键作用，直接解决了糖基化复杂性和异质性带来的挑战。我们详细介绍了 MS 技术（包括 MALDI-TOF MS、LC-MS 和串联 MS）在精确表征糖蛋白治疗药物方面的进步和应用。本综述强调了基于 MS 的免疫原性聚糖检测策略，并确保批次间的一致性，重点介绍了糖蛋白、糖肽和聚糖分析的针对性方法，以满足生物制药开发过程中严格的分析和监管要求。
MS-Based Glycome Characterization of Biotherapeutics With N- and O-Glycosylation.
With the increasing FDA approvals of glycoprotein-based biotherapeutics including monoclonal antibodies, cytokines, and enzyme treatments, the significance of glycosylation in modulating drug efficacy and safety becomes central. This review highlights the crucial role of mass spectrometry (MS) in elucidating the glycome of biotherapeutics that feature N- and O-glycosylation, directly addressing the challenges posed by glycosylation complexity and heterogeneity. We have detailed the advancements and application of MS technologies including MALDI-TOF MS, LC-MS, and tandem MS in the precise characterization of glycoprotein therapeutics. Emphasizing MS-based strategies for detecting immunogenic glycans and ensuring batch-to-batch consistency, this review highlights targeted approaches for glycoprotein, glycopeptide, and glycan analysis tailored to meet the stringent analytical and regulatory demands of biopharmaceutical development.
期刊介绍：
The aim of the journal Mass Spectrometry Reviews is to publish well-written reviews in selected topics in the various sub-fields of mass spectrometry as a means to summarize the research that has been performed in that area, to focus attention of other researchers, to critically review the published material, and to stimulate further research in that area.
The scope of the published reviews include, but are not limited to topics, such as theoretical treatments, instrumental design, ionization methods, analyzers, detectors, application to the qualitative and quantitative analysis of various compounds or elements, basic ion chemistry and structure studies, ion energetic studies, and studies on biomolecules, polymers, etc.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
