Protein Sequencing & Primary Structure Analysis
Protein sequencing is the first and most fundamental step in the structural characterization of biologics and biosimilars. While the amino acid sequence is encoded at the DNA level, the full characterization of a therapeutic protein goes far beyond the theoretical sequence. It starts with a robust confirmation of the expected primary structure and continues with the detection of sequence variants, terminal modifications and molecular weight differences that can affect function, stability and safety.
For any protein-based drug, verification of the theoretically expected primary structure should form the first pillar of detailed structural analysis. At Biofidus, our comprehensive analytical portfolio includes a range of state-of-the-art protein sequencing services to determine the exact amino acid sequence, identify N- and C-terminal modifications, confirm intact molecular weight and detect potential sequence variants or mutations.
Our extensive experience allows us to guide you through the available methods and define the optimal analytical strategy for your project.
In accordance with your needs, we adapt and, where required, qualify (according to ICH guidelines) our platform methods, tailored to your drug substance, its formulation matrix and your specific analytical questions, from early research to comparability, biosimilarity and commercial lifecycle management.
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist.
