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.

随着生物制药市场规模的成倍增长，数据丰富的分析的重要性与日俱增，这不仅是为了评估药物产品的安全性，而且是由于对结构/功能关系的更深入了解而推动的药物开发。在单克隆抗体中，许多功能是由存在于重链恒定区的N-聚糖调节的，其作用机理尚不完全清楚。其功能的重要性使分析研究工作集中在开发鲁棒，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，这并不是定量分析糖型异质性的唯一方法。在这项研究中，使用四种单克隆抗体比较了十种不同的N-聚糖分析工作流程。在观察所产生的定量结果之间具有良好的可比性的同时，有可能认识到每种技术的优缺点，并总结所有观察结果，以指导根据应用和所期望的数据深度选择最合适的分析工作流程。