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

Poster Presentations

Day 2, May 16（Tue.）　　Room P (Foyer, Room 1004-1007)

2P-42　　PDF

Interlaboratory study of Multi-Attribute Method (MAM) for Antibody Therapeutics – Post-Translational Modification (2) Oxidation –

(1Eisai, 2Daiichi-Sankyo, 3Astellas Pharma, 4Shionogi, 5Sawai, 6Taiho, 7Chugai Pharm., 8NIMS, 9Tsukuba Univ.)
oMami Gomibuchi1, Takahiro Kogaki2, Naoki Kawase3, Masaaki Imono4, Masaaki Senda5, Yuta Kobayashi6, Maki Yoshida7, Kohsaku Kawakami8,9

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.