Intact Mass Analysis of Monoclonal Antibody (MAb) Charge Variants Separated Using Linear pH Gradient

Monoclonal antibodies can be highly heterogeneous due to modifications such as sialylation, deamidation, and C-terminal lysine truncation. Salt gradient cationexchange chromatography has been used with some success in characterizing MAb charge variants. However, additional effort is often required to tailor the salt gradient method for an individual MAb. In the fast-paced drug development environment, a platform method is desired to accommodate the majority of the MAb analyses.