生物仿制药
抗体依赖性细胞介导的细胞毒性
效力
糖基化
化学
药理学
生物
生物技术
抗体
免疫学
生物化学
单克隆抗体
体外
作者
Bing Yao,Di Zhang,Weirong Cao,Gaoqiang Yang,Wenbin Li,Xiwu Hui,Pingkai Ouyang,Guoguang Chen,Boning Liu
摘要
The proposed biosimilar candidate needs to demonstrate biosimilarity with reference products, and the quality target product profile and biosimilarity assessment criteria are prerequisite, which should be based on extensive characterization of the reference products. In this study, 13 lots of China-sourced pertuzumab (trademark: Perjeta®), with an expiration date from 2020 to 2021, were comprehensively characterized. Despite the consistency of purity, drifts in N-glycan profile were observed, which resulted in the variation of antibody-dependent cellular cytotoxicity (ADCC) activity. In detail, four parametric curves of ADCC activity of the reference product were unparalleled, and the maximum response value was highly related to the content of %afucose than half-maximal effective concentration (EC50). As ADCC is a potential critical quality attribute of Perjeta®, the glycosylation of Perjeta® and its biosimilars should be tightly monitored and controlled.
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