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-41　　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 (1) 脱アミド修飾–

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

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.