Comparing different domains of analysis for the characterisation of N-glycans on monoclonal antibodies
Comparing different domains of analysis for the characterisation of N-glycans on monoclonal antibodies
复制标题
DOI：
10.1016/j.jpha.2019.11.008
复制
发表时间：
2020-02-01
影响因子：
8.8
通讯作者：
Bones, Jonathan
中科院分区：
文献类型：
--
作者：
Carillo, Sara;Perez-Robles, Raquel;Bones, Jonathan
随着生物制药市场的规模呈指数级增长，数据丰富的分析的重要性也随之增长，不仅可以评估药品安全性，还可以通过更深入地了解结构/功能关系来帮助药物开发。在单克隆抗体中，许多功能由重链恒定区中存在的N-聚糖调节，其作用机制尚不完全清楚。其功能的重要性使分析研究工作集中在开发强大，准确和快速的方法上，以支持药物开发和质量控制。释放的N-聚糖分析被认为是糖基化表征的金标准;然而，它不是糖型异质性定量分析的唯一方法。在本研究中，使用4种单克隆抗体比较了N-聚糖分析的10种不同分析工作流程。在观察到所产生的定量结果之间具有良好的可比性的同时，可以了解每种技术的优缺点，并总结所有观察结果，以指导根据应用和所产生数据的预期深度选择最适当的分析工作流程。(C)2019西安交通大学。制作和主办：Elsevier B. V.
With the size of the biopharmaceutical market exponentially increasing, there is an aligned growth in the importance of data-rich analyses, not only to assess drug product safety but also to assist drug development driven by the deeper understanding of structure/function relationships. In monoclonal antibodies, many functions are regulated by N-glycans present in the constant region of the heavy chains and their mechanisms of action are not completely known. The importance of their function focuses analytical research efforts on the development of robust, accurate and fast methods to support drug development and quality control. Released N-glycan analysis is considered as the gold standard for glycosylation characterisation; however, it is not the only method for quantitative analysis of glycoform heterogeneity. In this study, ten different analytical workflows for N-glycan analysis were compared using four monoclonal antibodies. While observing good comparability between the quantitative results generated, it was possible to appreciate the advantages and disadvantages of each technique and to summarise all the observations to guide the choice of the most appropriate analytical workflow according to application and the desired depth of data generated. (C) 2019 Xi'an Jiaotong University. Production and hosting by Elsevier B.V.