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-41　　PDF

Interlaboratory study of Multi-Attribute Method (MAM) for Antibody Therapeutics – Post-Translational Modification (1) Deamidation –

(1Shionogi, 2Astellas Pharma, 3Eisai, 4Sawai Pharmaceutical, 5Taiho Pharmaceutical, 6Daiichi-Sankyo, 7Chugai Pharm., 8NIMS, 9Univ. Tsukuba)
oMasaaki Imono1, Naoki Kawase2, Mami Gomibuchi3, Masaaki Senda4, Yuta Kobayashi5, Takahiro Kogaki6, Maki Yoshida7, Kohsaku Kawakami8,9

Antibodies undergo various post-translational modifications (PTM) during the manufacturing process, resulting in structural heterogeneity. In recent years, the multi-attribute method (MAM), which is rooted in traditional peptide mapping methods, has been proposed and developed for simultaneous detection, identification, and quantitation of PTMs.
The “Materials Open Platforms for Pharmaceuticals”, center of excellence (CoE), was launched in 2021 by National Institute for Materials Science together with 11 Japanese pharmaceutical companies to promote joint research and improve their characterization capabilities.
NIST Reference Material 8671 was used as a model antibody and the difference in PTMs among 7 companies was evaluated. In this presentation, the results of the investigation of deamidated forms are reported. In the case of the digestion in each company, the difference in the detection and quantitation of deamidations among company was greatly observed. Since the difference was reduced in the case of the digestion standard, some differences can be derived from sample preparation process. Certain differences remained even in digestion standard, and the effect of peak separation of LC was considered. The difference among companies was further reduced in the additional study using the same column lot, suggesting the LC peak resolution and robustness are important for quantitation of deamidation.