演題概要

オーラルセッション

第3日 5月19日(金) 15:25~15:45 B会場(102)

ゲル電気泳動からの抽出とインタクト質量分析法による抗体医薬品の高選択的特性解析手法の構築

(1武田薬品2近大薬)
o山田英丙1松村千恵美2山田佳太2手島浩一郎1廣島高志1木下充弘2鈴木茂生2掛樋一晃2

Characterization of heterogeneities in monoclonal antibody (mAb) therapeutics is performed to secure their quality and safety by physicochemical analyses. Considering the advantages of electrophoresis and MS, this study addresses the combination of SDS-PAGE and intact mass analysis, which provides direct, rapid and orthogonal determination of heterogeneities in mAb therapeutics. mAb therapeutics that migrated in SDS-PAGE were recovered from gel by treatment with sodium deoxycholate (SDC) containing buffer. The heterogeneities, especially N-glycan variants in the recovered mAb therapeutics, were clearly determined by intact mass analysis. We believe that the study is important in pharmaceuticals' perspective since orthogonal combination of gel electrophoresis and intact mass analysis should be pivotal role for rapid and precise characterization of mAbs.