The Dual-Integrated Multi-Attribute Method: Simultaneous Evaluation of Post-Translational Modifications and Host Cell Proteins for Unpurified Bulk Harvest of Antibody Therapeutics.

ABSTRACT: The Multi-Attribute Method (MAM) using liquid chromatography/mass spectrometry (LC/MS) is widely applied to evaluate post-translational modifications (PTMs) in antibody therapeutics. This approach allows the monitoring of multiple PTMs within a single method. In this study, we extended the scope of MAM by incorporating host cell proteins (HCPs) as additional targets and developed a dual, integrated PTMs-HCPs MAM platform. This platform enables the simultaneous evaluation of more comprehensive critical quality attributes through a combination of MS1-based PTMs analysis and data-independent acquisition-based HCP quantification. Although proteomics-based characterization of residual HCPs has been extensively reported, prior studies have primarily focused on purified drug substances or product

SUBMITTER: Kawase N 

PROVIDER: S-EPMC12917821 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature