3B-O2-1525 PDF
Highly Selective mAbs Characterization Methodology based on a Combination of Passive Extraction from SDS-PAGE Gel and Intact Mass Analysis
Characterization of heterogeneities in monoclonal antibody (mAb) therapeutics is performed to secure their quality and safety by physicochemical analyses. Considering the advantages of electrophoresis and MS, this study addresses the combination of SDS-PAGE and intact mass analysis, which provides direct, rapid and orthogonal determination of heterogeneities in mAb therapeutics. mAb therapeutics that migrated in SDS-PAGE were recovered from gel by treatment with sodium deoxycholate (SDC) containing buffer. The heterogeneities, especially N-glycan variants in the recovered mAb therapeutics, were clearly determined by intact mass analysis. We believe that the study is important in pharmaceuticals' perspective since orthogonal combination of gel electrophoresis and intact mass analysis should be pivotal role for rapid and precise characterization of mAbs.