Enzyme Characterization
A robust enzyme characterization program is essential to ensure the structural and functional integrity of therapeutic and technical enzymes. Because enzymes are highly structure-dependent catalysts, even subtle changes in primary structure, post-translational modifications, glycosylation or higher-order structure can significantly affect activity, stability and safety, and therefore must be understood with a coordinated set of analytical assays.
At Biofidus, detailed enzyme and protein characterization is part of our daily routine. Our analytical service platform covers in-depth primary structure analysis and sequence confirmation, amino acid and post-translational modifications (PTMs), purity and concentration determination, and functional evaluation in biochemical and cell-based assays (e.g. specific activity, kinetic parameters).
We are specialists in protein glycosylation analysis, a key modification influencing enzyme function, half-life, stability and immunogenicity in biopharmaceutical applications. Using advanced LC-MS/MS, chromatographic, electrophoretic and bioassay technologies, we design fit-for-purpose enzyme characterization packages.
Our extensive experience allows us to guide you through the variety of available methods and define the optimal analytical strategy for your project.
We adapt our platform methods to the properties of your drug substance, its individual formulation matrix, and your specific analytical question, and qualify them as needed according to ICH guidelines.
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert
