オーラルセッション
- 第3日 5月13日（水） 14:50～15:10 B会場（1202）
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3B-O14-1450 PDF
抗体医薬品を対象としたMulti-Attribute Methodによる品質管理のための前処理手法の最適化
As a new approach for quality control of therapeutic antibodies, the Multi-Attribute Method (MAM) based on peptide mapping by LC/MS using a high-resolution accurate mass spectrometer has attracted attention. In addition to confirming the primary structure, MAM allows comprehensive relative quantifications of quality attributes such as glycan profile and charge variant from clipping of C-terminal lysine, which are usually analyzed by a panel of separation methods, in a single LC/MS run. However, there are some issues to be addressed in sample preparation process of MAM. The major concerns are artificial modifications generated during sample preparation and generations of missed cleavages peptides. In this study, we report the optimization of sample preparation method for MAM for therapeutic antibodies.