Unification of Charge Heterogeneity, Purity, and Molecular Weight Analyses of mAbs into a Single Analysis
The continuous development and approval of increasingly more complex biopharmaceuticals presents analytical challenges traditional methods cannot always address. Charge heterogeneity, purity, and molecular weight analyses are powerful CE-based methods for mAb characterization. Combining similar CE separations of intact mAbs with mass spectrometric (MS) detection allows for unification of these three methods into one. The CESI-MS results are compared to existing industry-accepted CE-based charge heterogeneity, purity, and molecular weight analyses. Collectively, the results demonstrate the advantages of using MS as the detector for a charge heterogeneity analysis since it also provides molecular weight and purity information.
Key Learning Points
Multilevel characterization of IgG's with one separation method
Charge heterogeneity separation with on-line intact mAb MS detection
Disulfide bond mapping for mAb integrity
Full peptide mapping coverage for ID, purity & stability