Enhanced Detection of Host-Cell Proteins in Biotherapeutic Preparations using Preparative Electrophoresis Followed by LC–Ion Mobility-MS

This application note explains the fractionation of Host-cell proteins (HCPs) away from biotherapeutic protein using an off-line preparative electrophoresis device, allowing for sub-ppm level HCP detection. HCPs are proteins produced by the host cells during recombinant protein drug production and can contaminate the therapeutic drug protein even at very low levels. Detection of HCPs was improved through fractionating both the intact and reduced monoclonal antibody.