Author Archives: Chantal Felten, PhD

Imaged Capillary Isoelectric Focusing for Charge-Variant Analysis of Biopharmaceuticals

    Analyzing charge variants of therapeutic proteins is critical for characterizing and monitoring quality attributes of antibodies. Charge variants include deamidation, formation of N-terminal pyroglutamate, aggregation, isomerization, sialylated glycans, antibody fragmentation, and glycation at the lysine residues. In some cases, such changes affect binding, biological activity, patient safety, and shelf life. The biopharmaceutical industry relies on tools such as ion-exchange chromatography (IEC), isoelectric-focusing gel electrophoresis (IEF), and capillary equivalents such as capillary isoelectric focusing (CIEF) and imaged CIEF (iCIEF)…