3P-16 PDF
高分解能ESI-QTOF-MSを用いたモノクローナル抗体の酸化修飾の評価
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.