title: Analysis of host-cell proteins in biotherapeutic proteins by LC/MS approaches.
abstract: A generic method for the identification and quantification of host-cell proteins (HCPs) in protein biopharmaceuticals is described. Therapeutic proteins and HCPs were converted to complex peptide mixtures following tryptic digestion. Comprehensive peptide separations were performed using online two-dimensional capillary liquid chromatography-(LC) involving high-pH reversed phase (RP)/low-pH RP separations. We applied this method to the analysis of HCP impurities in monoclonal antibody (mAb) preparations.
authors.affiliation: Waters Corporation, 34 Maple Street, Milford, MA, 01757, USA, Catalin_Doneanu@waters.com.
authors.forename: Catalin E
authors.initials: CE
authors.lastname: Doneanu
authors.forename: Weibin
authors.initials: W
authors.lastname: Chen
mesh_terms: D000911:Antibodies, Monoclonal / Q000302:isolation & purification*; D001688:Biological Products / Q000302:isolation & purification*; D002853:Chromatography, Liquid / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D013058:Mass Spectrometry / Q000379:methods*
chemical_list: D000911:Antibodies, Monoclonal; D001688:Biological Products