Stress-Induced Antibody Aggregates: Insights from Native SEC-MS with Postcolumn Denaturation.

ABSTRACT: Characterization of high-molecular-weight species (HMWS) that are formed under forced stress conditions is a key component of degradation pathway studies performed during late-stage development for monoclonal antibody (mAb) therapeutics. Native mass spectrometry (MS) is a powerful technique for probing the structure and composition of HMWS. It offers high mass accuracy (surpassing that of the gold-standard SEC-MALS analysis), good sensitivity, and specificity. However, the routine implementation of this method in biopharmaceutical industry laboratories has been hindered by the special considerations required for data acquisition and interpretation. In this study, we present a systematic evaluation and the development of a platform method for native SEC-MS characterization of large aggregat

SUBMITTER: Ivanov D 

PROVIDER: S-EPMC12784411 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature