Host Cell Protein Clearance By Amsphere A3 And Other Commercially Available Protein A Resins

The level of host cell proteins (HCPs) is one of the critical quality attributes of biopharmaceuticals. Clearance of these HCPs is one of the performance parameters of the downstream process (DSP) of antibody production. Generally, the majority of HCPs in harvested cell culture fluid is removed during the affinity capture step using Protein A chromatography. Remaining HCPs are removed in subsequent polishing steps by a combination of ion-exchange, hydrophobic interaction, or mixed-mode techniques. Thus, identification of the remaining HCPs after the Protein A step can provide valuable information for the resin choice and development of the polishing process. In this study, HCPs in elution samples of Protein A chromatography were evaluated with ELISA (quantitative analysis) and 2D-LC/MS (qualitative analysis). Results for Amsphere A3 were compared with two other commercially available resins.