演題概要

シンポジウムセッション

第1日　5月15日（月）　13:30～13:53　A会場（特別会議場）

1A-S-1330　　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

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

The multi-attribute method (MAM) is an analytical method using high-resolution LC-MS to quantify post-transrational modifications (PTMs) of therapeutic antibodies. The concept of MAM was recently proposed and research in MAM has been conducted globally, especially the US and European countries. On the other hand, a progress in this research field in Japan has been behind those countries. In 2021, the National Institute for Materials Science (NIMS) and 7 Japanese pharmaceutical companies established a joint research group for MAM in “Materials open platform (MOP) for pharmaceutical science” of NIMS (Platform director: Kohsaku Kawakami, NIMS), which is a framework designed to facilitate joint research by competing companies within the same industry. In this joint research, a comparative study was conducted among attending companies using NIST-mAb to evaluate company-to-company variations in measured values of PTMs. In this study, we obtained some findings for reducing the variations. In this presentation, we will introduce an overview of this joint research and the current progress.