摘要
一些生物技术产品,比如促红细胞生成素和单克隆抗体(mAbs)等,可以发生糖基化作用,这一性质显著影响了它们在体内的安全性和治疗效果。这些治疗用糖蛋白发生糖基化作用后生成多糖,从而影响了它们的生物活性和稳定性,这也是造成生物技术产品生产过程中出现批次差异的主要因素。
Glycosylation can significantly affect the in vivo safety and efficacy profiles of biopharmaceuticals such as erythropoietin and monoclonal antibodies (mAbs). The resulting glycans, which can influence the biological activity and stability of these therapeutic glycoproteins, are a major cause of batch-to-batch variability during their production.