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-42　　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 (2) 酸化修飾–

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

The "Materials Open Platform (MOP) for Pharmaceuticals" is a center of excellence (COE) launched in 2021 by the National Institute for Materials Science together with domestic pharmaceutical companies. The antibody analysis group, which is one of the COE groups consisting of seven pharmaceutical companies, focused on the Multi Attribute Method (MAM), a technique for monitoring multiple characteristics by mass spectrometry. The standardization of analysis methods is being promoted among the barriers of companies. Discussions are also being held with a view to utilizing it as a quality test item in the future.
Peptide map quantification method by mass spectrometry for post-translational modifications of antibodies is optimized. The analytical sample used is NIST- mAb, which has been extensively evaluated around the world.
As a result of the investigation, it was found that not only the quantitative results of post-translational modifications but also the types of post-translational modifications detected differed greatly among companies. The cause was found to be the difference in sample preparation method, LC-MS analysis, and experimental conditions at some stages of the analysis. A standard method was found that always gave a same result, even if each company performed it.