3P-16 PDF
Evaluation of the oxidation of monoclonal antibodies with ultra-high resolution ESI-QTOF-MS
Oxidation is the one of the chemical modifications in biopharmaceuticals and occurs during manufacturing, shipping, and storage processes. In particular, in the case of monoclonal antibodies (mAbs), it is well-known that oxidation of methionine residues affects not only the binding affinity of mAbs to FcR but also the serum half-life. Therefore it is of importance to perform the rapid and quantitative evaluation of the site-specific oxidation of mAbs.
Currently, although the peptide mapping is widely used for the detection and the quantification of the site-specific chemical modification in mAbs, sample preparations, analyses, and data processing are not compatible with high-throughput analysis. In addition, it is difficult to evaluate the heterogeneity of the chemical modifications. In this study, MS analyses of IdeS-derived IgG subunits were performed using an ultra-high resolution ESI-QTOF-MS to evaluate the oxidation of mAbs.