Monoclonal antibodies have been increasingly becoming drug candidates for disease therapeutics. Due to the molecular complexity of monoclonal antibodies, the characterization remains a challenge and required step throughout the development and manufacturing process. In order to determine the efficacy of the molecules, aggregation, heterogeneity such as charge variants, C-terminal lysine processing, deamidation, glycosylation, MAbs must be screened for their structural and biological changes.
In the kit, the Zenix™-300 size exclusion chromatographic (SEC) column is designed for high efficiency and resolution separation of monoclonal antibody monomers, aggregates, fragments such as heavy/light, fab/fc and f(ab')2 fragments. With volatile mobile phase systems, Zenix-300 is able to separate MAb fragments, which can be analyzed by on-line mass spectrometry. Molecular weight information of MAb fragments is then obtained with SEC-LC/MS work flow. The antibody solution kit provides AntibodixTM NP5 weak cation exchange column to separate the charge variants. Multiple mobile phase systems were investigated for optimum charge variant separation.
With Zenix™-300 SEC and Antibodix NP5, antibody solution kit offers a complete set of tools for monoclonal antibody analysis.