Measuring low levels of protein aggregation by sedimentation velocity.

摘要: The required performance of an analytical method depends on the purpose for which it will be used. As a methodology matures, may find new application, and demands placed can increase. Sedimentation velocity ultracentrifugation (SV-AUC) has long distinguished history with important contributions to molecular biology. Now technique is transitioning into industrial settings, among them, SV-AUC now used quantify amount protein aggregation in biopharmaceutical products, often at levels less than 1% total mass. In this paper, we review recent advances SV have been shown improve quantitation aggregation. Then discuss its current state, emphasis precision limit method, context existing guidance targets quantitative methods.