Published Paper Details:

Size exclusion chromatography (SEC) may be a historical technique widely employed for the detailed characterization of therapeutic proteins and may be considered as a reference and powerful technique for the qualitative and quantitative evaluation of aggregates. the most advantage of this approach is that the mild mobile phase conditions that let the characterization of protein with minimal impact on the conformational structure and native environment. Despite the very fact that the chromatographic behavior and peak shape are hardly predictable in SEC, some generic rules are often applied for SEC method development. Recent developments are reviewed in size exclusion chromatographic calibration methodologies, including direct calibration by using narrow and broad polymer standards and various instrumental methods (nuclear resonance, mass spectrometry, light scattering) also as universal calibration with and without viscometer detectors, for easy and sophisticated polymers. the utilization and number of bio therapeutics has increased significantly. For these largely protein-based therapies, the quantization of aggregates is of particular concern given their potential effect on efficacy and immunogenicity. This requirement has renewed interest in size-exclusion chromatography (SEC).