Rapid Level 3 Characterization of Biologics using a CESI 8000 – Thermo Q-Exactive Platform Comprehensive Qualitative and Quantitative Analysis of Biopharmaceuticals Using CESI-MS Technology

In the biopharmaceutical industry, comprehensive and reproducible characterization of monoclonal antibody therapeutics (mAbs) is crucial, as impurities and heterogeneity can impact safety and/or efficacy. mAbs are large glycosylated proteins (≈ 150 kDa) contain several other post-translational modifications (PTMs). Peptide mapping of mAbs can provide critical qualitative and quantitative information about impurities and heterogeneity. 1-2 Capillary electrophoresis (CE) in conjunction with mass spectrometry has exceptional separation efficiency and capabilities for peptide and glycopeptide mapping (Characterization Level 3) of mAbs. The application of an electrospray ionization (ESI) emitter integrating CE and ESI into a single dynamic process (CESI) has already proven useful for peptide and mAb analysis. 3-7

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