Protocols for the analytical characterization of therapeutic monoclonal antibodies. I – Non-denaturing chromatographic techniques

摘要: Size-, charge- and hydrophobicity-related variants of a biopharmaceutical product have to be deeply characterized for batch consistency the assessment immunogenicity safety effects. Size exclusion chromatography (SEC) ion exchange (IEX) are considered as gold standard analysis high molecular weight species (HMWS) charge-related variants, respectively. Hydrophobic interaction (HIC) has drawn renewed attention monitor small drug payload distribution in cysteine-linked antibody-drug conjugates (ADC). These three chromatographic techniques, namely SEC, HIC IEX, historical, non-denaturing robust approaches widely used characterization proteins. Despite broad spectrum monoclonal antibodies (mAbs) structures, isoelectric points (pIs) hydrophobicities, generic protocols can applied separate their size-, using last generation columns appropriate mobile phase conditions. Straightforward described this manuscript with representative chromatograms ten distinct Food Drug Administration (FDA) European Medicines Agency (EMA) approved therapeutic mAb products illustrate performance IEX methods.