Analytical tools for the characterization of deamidation in monoclonal antibodies

Abstract

This review focuses on the deamidation of asparagine in monoclonal antibodies, one of the well-known degradation pathways. The importance of close monitoring of deamidation from early developability assessment to in vivo studies is discussed consequentially. The application of chromatographic and electrophoretic instruments for the separation of deamidated variants is described. Current mass spectrometric approaches for characterization of deamidated antibody variants and localization of modification sites are discussed accordingly. The review also covers the challenges in bioanalysis of deamidated forms in complex biological matrices during in vivo studies.