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Day 3, June 24(Tue.) 12:10-12:25
Room A (Maesato West)
- 3A-O1-1210
Multi Attribute Method for antibody therapeutics
(Astellas Pharma Inc.)
oNaoki Kawase
Monoclonal antibodies have emerged as one of the most widely used biotherapeutics. Certain post-translational modifications (PTMs) are recognized as critical quality attributes (CQAs) for antibody therapeutics, and their impact on patient safety and efficacy has been thoroughly evaluated. In general quality control strategies, multiple chromatographic and electrophoresis-based analytical methods have been employed to indirectly assess these PTMs. Recently, Multi-Attribute Method (MAM) was proposed as a direct approach for monitoring PTMs through peptide mapping combined with high-resolution mass spectrometry. MAM enables to calculate modification ratio for various PTMs at each modification site, making it increasingly popular not only for product characterization but also for quality control in compliance with Good Manufacturing Practice (GMP). However, compared to traditional chromatographic and electrophoresis-based methods, knowledge regarding this analytical technology remains limited. This presentation will discuss MAM's application in analyzing unpurified samples, the development of automated sample preparation, and collaborative research among Japanese pharmaceutical companies to standardize MAM methodologies and improve reproducibility.