Sodium caprylate induced precipitation post Protein A chromatography as an effective means for host cell protein clearance

Abstract

In downstream processing of monoclonal antibody (mAb), post Protein A neutralization and subsequent intermediate depth filtration are critical steps for host cell protein (HCP) clearance. Previous studies have shown that adding caprylic acid (CA) during neutralization can further improve HCP removal by promoting their precipitation. In this study, we replaced CA with its sodium salt – sodium caprylate (SC). For the five mAbs studied, SC has been shown to be equally effective as CA at precipitating HCPs. As the salt form has a higher solubility, SC stock solution with relatively high concentration can be easily prepared, which facilitates its adding to the Protein A elution pool. Thus, this study not only confirms the effectiveness of CA/SC-induced HCP precipitation but also provides a more convenient way to integrate this method into the downstream process.