演題概要

ポスター発表

第2日　5月16日（火）　　P会場（ホワイエ，会議室1004-1007）

2P-43　　PDF

抗体医薬品に対するMulti-attribute method (MAM) の国内発展を目指した製薬企業連携 -試験サイト間差低減に向けた検討 (3) C末端Lysクリッピング-

(¹大鵬薬品・ ²アステラス製薬・ ³塩野義製薬・ ⁴第一三共・ ⁵エーザイ・ ⁶沢井製薬・ ⁷中外製薬・ ⁸物材機構・ ⁹筑波大学)
^o小林裕太¹・ 川瀬直樹²・ 鋳物将明³・ 小垣考弘⁴・ 五味渕真美⁵・ 千田真彰⁶・ 吉田麻希⁷・ 川上亘作^8,9

The Multiple Attribute Method (MAM), based on peptide mapping by LC/MS2 analysis, is an analytical method that provides a better understanding of the quantitative evaluation of antibody drug heterogeneities.
The National Institute for Materials Science (NIMS) and 11 pharmaceutical companies in Japan have established a Materials Open Platform (MOP) as a Center of Excellence (COE) in 2021, which aims to improve the infrastructure of research and development and standardize development methods. The Antibody Analysis Group, one of the groups in the COE, is organized to develop the MAM in Japan.
In this presentation, we will present our findings from the analysis of C-terminal Lys-Clipping in the experiment. The mass spectra obtained by MAM are generally detected as Multi-charged ions. The results of the Lys-Clipping analysis suggest that the variation of the quantification value among companies may be reduced by matching the charge status of the peptides for which ion intensities are calculated for Clipping and non-Clipping peptides when calculating the percentage of Lys-Clipping.