Characterization of intact therapeutics and protein subunits using CE-MS platform

Abstract

Recent years has seen a growing interest in mass spectrometry (MS) characterization of monoclonal antibodies (mAbs) and other biotherapeutics at intact protein or protein subunit levels, sometimes called "Top-Down" or "Middle-Up/Middle-Down" MS. This approach, when coupled to a high-resolution separation technique such as capillary electrophoresis (CE), may provide opportunities for direct and unambiguous identification of protein therapeutics as well as their variants or post-translational modifications. This chapter introduces a few recent CE-MS or CE-tandem MS works that aimed at identification of therapeutic proteins charge variants, glycoforms, and antibody-drug conjugates at the intact protein or protein subunit levels.