Size Exclusion Chromatography (SEC)
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Size exclusion chromatography (SEC) is a classical technique widely used for the detailed characterization of therapeutic proteins and can be considered as a reference and powerful technique for the qualitative and quantitative evaluation of aggregates. SEC is considered as a nondenaturing technique with mild mobile phase conditions, which allows the characterization of biomolecules without affecting their structure, conformation or local environment. Creative Proteomics offers high-resolution separation and analysis techniques based on volumetric exclusion chromatography (SEC) systems to characterize macromolecules and their aggregates in antibody drugs. Our optimized workflow reduces analysis time and increases sample throughput to provide detailed and comprehensive characterization results.
Application of SEC in Characterization of Antibody Drugs
The level of aggregation in antibody drugs is rather a crucial quality attribute due to their potential immunogenicity. While numerous techniques have been developed to monitor aggregates, size exclusion chromatography (SEC) has been predominantly favored for routine and validated analyses because of both its speed and reproducibility. SEC separates biomolecules according to their hydrodynamic radius. The stationary phase consists of spherical porous particles with a carefully controlled pore size, through which the biomolecules diffuse based on their molecular size difference using an aqueous buffer as the mobile phase. Smaller molecules can enter the pores and are thus delayed in their migration through the column, while larger molecules elute faster. This technique is effective in analyzing key attributes of antibody drugs as it enables the separation of monomer and aggregate forms of the drug, which is crucial for assessing drug purity and stability.
Advantages of Size Exclusion Chromatography
- Simple and reproducible: No complex sample preparation or derivatization is required, providing highly reproducible results.
- High sensitivity and resolution：SEC has excellent resolution and sensitivity for detecting and quantifying protein aggregates, fragments and other impurities in antibody drugs at very low concentrations.
- Rapid separation: SEC technology allows for rapid analysis of multiple samples in a relatively short period of time, resulting in increased throughput and shorter drug detection times.
Our Capabilities
- Advanced detection technology and equipment
Creative Proteomics offers advanced size exclusion chromatography techniques and related equipment, including specialized columns with porous beads, UV detectors for more advanced analysis, refractive index (RI) or light scattering detectors, HPLC in conjunction with them, and other detection techniques.
- SEC method development and validation
Our experienced scientists work closely with our customers to understand their assay demands and sample characteristics. We provide customization of key assay parameters, including SEC column type, stationary phase, and assay method selection to ensure accurate and reliable results.
Once the test plan is finalized, our skilled experts provide one-stop comprehensive testing services covering sample handling, column equilibrium, sample testing and data analysis.
With many years of experience in the field, Creative Proteomics has accumulated extensive expertise in providing quality and reliable SEC services to support antibody drug development. Contact us to learn more about our service and we will be happy to serve you.
