Complete characterization and analysis of biopharmaceuticals includes size exclusion chromatography (SEC) to measure protein aggregates and other size variants. Current silica-based HPLC-SEC methods can be time-consuming and unreliable. New advances in packing materials and instrumentation have allowed faster and more reproducible separations to be achieved.

Improvements in resolution, sensitivity and throughput will be demonstrated for sub-2 μm SEC packing materials as compared to traditional silica-based columns. The effect of pore size and particle size for the analysis of aggregates and lower molecular weight species will be demonstrated. Other variables such as mobile phase composition and formulation excipients will also be evaluated. These studies will demonstrate the improvements in impurity detection and/or faster analysis of biomolecules

achievable with UPLC®-SEC separations.