Analytical tools for the characterization of deamidation in monoclonal antibodies

•An overview of monoclonal antibodies deamidation from the point of view of manufacturability, storage, and in vivo biotransformation.•Application of chromatographic and electrophoretic methods for the separation of deamidated antibody variants.•Mass spectrometric challenges in characterization of deamidation products.•Bioanalysis of deamidated antibody variants in complex biological samples. 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. [Display omitted]