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-42 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 (2) 酸化修飾–
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.