Polysaccharide molecular mass is an important parameter to monitor for potency and stability of polysaccharidebased vaccines. In fact, reduction in molecular mass of polysaccharide preparations below a threshold minimum can result in reduced immunogenicity. Therefore, molar mass is a critical quality attribute of these products that must be monitored in QC.
Multi-angle light scattering coupled to high-performance size exclusion chromatography (SEC-MALS) is an ideal method for monitoring the molecular mass of homopolymeric solutions and is utilized in development of each monovalent immunogenic polysaccharide. However, polysaccharide vaccines typically contain mixtures of different components that have similar sizes and cannot be characterized as-is by light scattering. For QC of these materials, a different technique must be used. The secondary technique must be traceable to a highly-reliable analytical method such as SEC-MALS.
