The Mass Spectrometry society of Japan - The 71st Annual Conference on Mass Spectrometry, Japan
Japanese

Abstract

Table of contents

Timetable

Plenary Lecture

Symposium Sessions (Day1, Day2, Day3)

Basic Sessions (Day1, Day2, Day3)

Young Researchers' Sessions (Day1, Day2, Day3)

Poster Presentations (Day1, Day2, Day3)

Special Evening Sessions

Corporate Program

Symposium Sessions

Day 1, May 15（Mon.）　13:30-13:53　Room A (Special Conference Room)

1A-S-1330　　PDF

Interlaboratory study of Multi-Attribute Method (MAM) for Antibody Therapeutics

(1Astellas Pharma, 2Eisai, 3Sawai Pharm., 4Shionogi, 5Taiho Parm., 6Daiichi-Sankyo, 7Chugai Pharm., 8NIMS, 9Univ. Tsukuba)
oTaishi Kusama1, Naoki Kawase1, Mami Gomibuchi2, Masaaki Senda3, Masaaki Imono4, Yuta Kobayashi5, Takahiro Kogaki6, Maki Yoshida7, Kohsaku Kawakami8,9

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.