NMR-based Structural Integrity Analysis of Monoclonal Antibodies

This research article explores the analytical comparability of therapeutic monoclonal antibodies (mAbs) and their biosimilars, focusing on Humira. Using NMR spectroscopy, the study assesses higher-order structure (HOS) under normal and stressed conditions, revealing significant structural differences influenced by formulation and container closure systems. The findings underscore NMR's utility in ensuring product quality and regulatory compliance for biologic therapies.