Rapid identification of antibody impurities in size-based electrophoresis via CZE-MS generated spectral library.

ABSTRACT: Methods for the reliable and effective detection and identification of impurities are crucial to ensure the quality and safety of biopharmaceutical products. Technical limitations constrain the accurate identification of individual impurity peaks by size-based electrophoresis separations followed by mass spectrometry. This study presents a size-based electrophoretic method for detecting and identifying impurity peaks in antibody production. A hydrogen sulfide-accelerated degradation method was employed to generate known degradation products observed in bioreactors that forms the basis for size calibration. LabChip GXII channel electrophoresis enabled the rapid (< 1 min) detection of impurity peaks based on size, while capillary zone electrophoresis-mass spectrometry (CZE-MS) facilitated th

SUBMITTER: Liu Q 

PROVIDER: S-EPMC11364755 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature