NMR-based structural integrity analysis of therapeutic monoclonal antibodies: a comparative study of Humira and its biosimilars.

ABSTRACT: The analytical comparability of biologic products and their biosimilars, including higher-order structure (HOS) assessment, ensures product quality and is required for regulatory approval. In this study, nuclear magnetic resonance (NMR) spectroscopy was used to evaluate the HOS of Humira (adalimumab) and its biosimilars under normal and photo-stressed conditions. Under normal conditions, 1D and 2D NMR spectra showed strong structural similarity among all products. However, photo-stressed samples exhibited distinct structural differences, including increased methionine oxidation, and localized conformational changes, most notably in the reference product. These changes correlated with findings from size-exclusion chromatography, capillary isoelectric focusing, and mass spectrometry (MS), wh

SUBMITTER: Baldisseri D 

PROVIDER: S-EPMC12427497 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature