Higher Order Structure Characterization

In contrast to small molecule drugs, protein-based biologics are produced in living cultures in which the simple amino acid sequence (primary structure) is transformed into complex three-dimensional secondary, tertiary or even quaternary structures through the formation of disulfide, hydrogen or ionic bonds.​

The detailed characterization of these higher order structures (HOS) is considered a critical quality attribute (CQA) during the manufacturing of biopharmaceutical compounds, as the structure and conformation of protein-based drug is key for its functionality and safety. Regulatory agencies like FDA or EMA expect a combination of physicochemical HOS characterization combined with functional assays, to determine the biological activity of biologics or biosimilars. Biofidus offers a variety of analytical services like customized cell-based assays, LC-ESI-MS, fourier-transforminfrared spectroscopy (FTIR), circular dichroism (CD) or differential scanning calorimetry (DSC) for a detailed characterization of HOS.​

The insights gained from these studies not only provide necessary knowledge about your product efficacy, quality and safety, but also guides the development of process control strategies to avoid or reduce critical changes in the HOS during the manufacturing process. ​

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.