Zhang Lei, Luo Shen, Zhang Baolin
a Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring , Maryland.
MAbs. 2016;8(2):205-15. doi: 10.1080/19420862.2015.1117719. Epub 2015 Nov 24.
Therapeutic monoclonal antibodies (mAbs) are glycoproteins produced by living cell systems. The glycan moieties attached to the proteins can directly affect protein stability, bioactivity, and immunogenicity. Therefore, glycan variants of a glycoprotein product must be adequately analyzed and controlled to ensure product quality. However, the inherent complexity of protein glycosylation poses a daunting analytical challenge. This review provides an update of recent advances in glycan analysis, including the potential utility of lectin-based microarray for high throughput glycan profiling. Emphasis is placed on comparison of the major types of analytics for use in determining unique glycan features such as glycosylation site, glycan structure, and content.
治疗性单克隆抗体(mAb)是由活细胞系统产生的糖蛋白。附着在蛋白质上的聚糖部分可直接影响蛋白质的稳定性、生物活性和免疫原性。因此,必须对糖蛋白产品的聚糖变体进行充分分析和控制,以确保产品质量。然而,蛋白质糖基化固有的复杂性带来了艰巨的分析挑战。本综述介绍了聚糖分析的最新进展,包括基于凝集素的微阵列在高通量聚糖分析中的潜在应用。重点比较了用于确定独特聚糖特征(如糖基化位点、聚糖结构和含量)的主要分析方法。