Rapid, Autonomous Lot-to-Lot Comparability of Monoclonal Antibodies with the Calypso

Analysis of purity is essential throughout the drug development process. This application note describes a common approach of evaluating relative levels of molecular weight forms using analytical size exclusion chromatography (SEC) in combination with multi-angle light scattering (MALS) and absorbance (UV) and/or refractive index (RI) concentration detectors and validation of these results using other MALS techniques. This article highlights how the Calypso system can be used to automate these experiments to save time and reduce the quantity of sample consumed.