Amino Acid Modification & PTM Analysis for Biologics and Biosimilars
Analysis of amino acid modifications is a key element of protein characterization and CMC development for biologics and biosimilars. Building on primary structure and sequence confirmation, one of the most important tasks is to identify and quantify post-translational amino acid modifications (PTMs) such as deamidation, oxidation, glycation, isomerization or clipping. These modifications occur ubiquitously in endogenous and recombinant proteins and can fundamentally influence function, stability, pharmacokinetics and immunogenicity, making their characterization particularly sensitive and accuracy-critical.
At Biofidus, our highly experienced scientists routinely and reliably distinguish non-critical modifications from those that may significantly impact the functionality and quality of your biologic or biosimilar.
We use state-of-the-art LC-MS–based methods, including peptide mapping and multiple attribute methods (MAM), to build a site-specific modification profile and link it to critical quality attributes (CQAs) and regulatory expectations. Our deep knowledge in PTM analysis allows us to guide you through the available approaches 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 API/drug substance, its formulation matrix and your specific analytical questions (e.g. stress studies, comparability, biosimilarity, release testing).
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist.
