Li Yifeng
Technology and Process Development (TPD), WuXi Biologics, 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, 200131, China.
Protein Expr Purif. 2019 Jan;153:92-96. doi: 10.1016/j.pep.2018.09.003. Epub 2018 Sep 8.
Caprylic acid (CA), a naturally occurring eight-carbon fatty acid, has long been used as albumin stabilizer, non-IgG fraction precipitant and bactericidal agent in pharmaceutical industry. The mechanisms through which CA achieves its effects have been correlated with the molecule's protein/lipid binding capacity conferred by its octyl moiety. This article, following an initial review of CA's historical applications, introduces CA's relatively new application in downstream processing of monoclonal antibodies (mAbs). By taking advantage of CA mediated impurity precipitation and virus inactivation, it might be possible to develop a two-column purification process in replacement of the standard three-column process without compromising product quality.
辛酸（CA）是一种天然存在的八碳脂肪酸，长期以来在制药工业中用作白蛋白稳定剂、非IgG组分沉淀剂和杀菌剂。CA发挥其作用的机制与其辛基部分赋予分子的蛋白质/脂质结合能力有关。本文在初步回顾CA的历史应用之后，介绍了CA在单克隆抗体（mAb）下游加工中的相对新应用。通过利用CA介导的杂质沉淀和病毒灭活作用，有可能开发一种双柱纯化工艺来替代标准的三柱工艺，同时不影响产品质量。
