For Reliable Size-Exclusion Chromatography Measurements

摘要

The complete characterization and analysis of biopharmaceuticals includes the application of size-exclusion chromatography (SEC) to measure protein aggregates and other size variants. Soluble protein aggregates in particular can contribute to immunogenicity. Accurate analysis and quantitation of biotherapeutic protein aggregates is therefore often required. Current HPLC/silica-based SEC methods can be time-consuming and unreliable. Their uncertain results may be due to changes in retention time, peakshape, or spacing between peaks as well as irreproducibility between columns and changes in columns within a few runs.