Host cell protein analysis using CE-MS

Abstract

Recombinant monoclonal antibodies (mAbs) as drug products are normally expressed in non-human cell lines and then purified by affinity chromatography. Low amount of residual host cell proteins (HCPs) still remain in the final products, causing potential safety risks. Capillary electrophoresis (CE) has been employed as a powerful separation tool coupling with mass spectrometry (MS) for the analysis of protein therapeutics. This chapter introduces studies that take advantages of CE-MS for the identification and quantification of trace amount of HCPs in antibody drug products.