Analysis of host-cell proteins in biotherapeutic proteins by LC/MS approaches
Catalin E Doneanu1, Weibin Chen
1Waters Corporation, 34 Maple Street, Milford, MA, 01757, USA, Catalin_Doneanu@waters.com.
Methods in Molecular Biology (Clifton, N.J.)
|March 21, 2014
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.


