Size variants of large molecule biologics contain truncated forms (fragments), aggregates, and other modified forms, which need to be identified. Size exclusion chromatography (SEC) separates size variants of protein according to the hydrodynamic volume of the molecules. It is widely used to characterize the total level as one of the critical quality attributes.
Yaohai Bio-Pharma offers size variant analysis services using Liquid Chromatography-Mass Spectrometry (LC-MS), Size-Exclusion Chromatography-Mass Spectrometry (SEC-MS), Capillary Electrophoresis (CE), Dynamic Light Scattering (DLS), Analytical Ultracentrifugation (AUC), Multi-angle light scattering coupled with size exclusion chromatography (SEC-MALS).
We have been involved in the Protein Structural Characterization of various large molecules, including Recombinant Subunit Vaccines, Nanobodies/VHHs/ Single-domain Antibodies (sdAbs), Antibody Fragments, Hormones/Peptides, Cytokines, Growth Factors (GF), Enzymes, Collagens, etc.
Regulatory Requirements for Size Variant Analysis
According to United States Pharmacopeia (USP), size exclusion chromatography (SEC) is a reliable method for determining high molecular weight species (HMWS) in native conditions, whereas CE-SDS is more reliable for quantifying low molecular weight species (LMWS) in denaturing conditions.
Analytical Methods
| Services |
Analytical Methods |
| Size variant analysisaggregate formation and product fragments |
SEC-MS, Size exclusion chromatography-Mass Spectrometry |
| Average size and aggregation state analysis |
DLS, Dynamic Light Scattering |
| Molecular size and sedimentation velocity (SV) analysis |
AUC, Analytical Ultracentrifugation |
| Molecular size of protein monomers and aggregates |
SEC-MALS, Multi-angle light scattering coupled with Size exclusion chromatography |
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