Fusion Protein Characterization Services
The ability of fusion proteins to combine the specific properties of different protein domains into a single biomolecule has enabled novel, highly targeted therapeutic approaches. Clinical examples such as Etanercept and Aflibercept show how rationally designed fusion constructs can deliver improved efficacy, extended half-life and enhanced stability compared with the corresponding native proteins. Because these molecules rely on correct domain fusion, linker design and post-translational modification patterns, they require specialized fusion protein characterization beyond standard protein analytics.
At Biofidus, we offer a holistic, state-of-the-art analytical platform for fusion protein characterization, covering both structural and functional aspects. We provide in-depth primary structure and sequence confirmation, post-translational modification and glycosylation analysis, assessment of size and charge variants, and purity and aggregation profiling using advanced LC-MS/MS, chromatographic and electrophoretic methods. To confirm biological function, we design and execute customized cell-based assays aligned with your mechanism of action, and perform binding and kinetics studies by surface plasmon resonance (SPR) or related technologies. This allows us to verify correct fusion, domain integrity and biological activity of your lead and development candidates, and to support comparability, biosimilarity, stability and developability studies across the lifecycle.
Our extensive experience with therapeutic fusion proteins and other complex biologics enables us to define the most suitable analytical strategies, focusing on the critical quality attributes (CQAs) of your drug substance.
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
