单抗产品中聚山梨酯20降解的分析与控制

Analysis and Control of Degradation of Polysorbate 20 in Monoclonal Antibody Products

一种单克隆抗体药物产品在(5±3)℃下长期保存后,聚山梨酯20发生降解生成游离脂肪酸,产生不溶性微粒和可见异物。本文通过优化产品工艺,增加一步疏水层析,去除催化聚山梨酯20降解的磷脂酶B2,有效抑制了聚山梨酯20的降解,避免了不溶性微粒和可见异物的产生。

After long-term storage at(5±3)℃,polysorbate 20 degrades to produce free fatty acids,insoluble particles and visible foreign bodies.In this paper,by optimizing the product process,adding one step hydrophobic chromatography to remove phospholipase B2 catalyzing the degradation of polysorbate 20,effectively inhibited the degradation of polysorbate 20,and avoided the generation of insoluble particles and visible foreign bodies.