AN3003: Lot-to-Lot Comparability Studies of Monoclonal Antibodies


Analysis of purity and demonstration of lot to lot comparability is essential throughout the drug development process. A common approach to evaluate the relative levels of molecular weight forms is to perform analytical size exclusion chromatography (SEC) in combination with multi-angle light scattering (MALS) and absorbance (UV) and/or refractive index (RI) concentration detectors.