Amino acid modifications
Building on the analysis of the primary structure, one of the most important tasks is to identify and quantify post-translational amino acid modifications. These modifications, which occur ubiquitously in natural as well as recombinantly produced proteins, can have a fundamental influence on the functionality of the protein, making their characterization subject of particularly sensitive and accurate analysis.
Our highly experienced scientists at Biofidus know how to routinely and reliably distinguish non-critical modifications from those that could have a significant impact on the functionality of your biologic or biosimilar.
Our deep knowledge in this field allows us to guide you through the variety of available state-of-the-art methods like LC-MS based multiple attribute methods (MAM) and helps you find the optimal analytical solution for your project.
In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your API, its individual formulation matrix and your distinct analytical question.
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist.
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We‘ll advice you to define your assay needs