Microheterogeneities are inherent features of monoclonal antibodies (mAbs) due to their susceptibility to chemical and enzymatic modifications. These heterogeneities impact both biotherapeutic efficacy and safety, and accordingly are a critical quality criterion.
Many of these modifications generate slight differences in charge including oxidation, deamidation, lysine truncation, etc. These charge differences can be separated in the native state using ion exchange chromatography (IEX) and detected using mass spectrometry (MS).
Herein, we present work showing the efficient analyses of mAb charge variants, at both the intact and subunit levels, using the BioResolve Strong Cation Exchange (SCX) mAb column and IonHance CX-MS buffers._1596695733733