Higher Order Structure (HOS) Analysis for Biologics & Biosimilars
In contrast to small molecule drugs, protein-based biologics are produced in living systems, where a simple amino acid sequence (primary structure) is folded into complex secondary, tertiary and quaternary structures through disulfide bonds, hydrogen bonds, ionic interactions and non-covalent forces. This higher order structure (HOS) is often crucial for target binding, potency, stability and safety.
Because of this, detailed HOS characterization is considered a critical quality attribute (CQA) during the development and manufacture of biopharmaceuticals. Regulatory authorities such as FDA and EMA expect a combination of physicochemical HOS methods together with functional bioassays to demonstrate that a biologic or biosimilar maintains the correct conformation and biological activity.
At Biofidus, we offer a broad range of HOS analytical services – including circular dichroism (CD), Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), LC-ESI-MS–based approaches and custom cell-based assays – to provide an integrated view of structure and function. The insights from these studies support efficacy, quality and safety assessments, and guide process development and control strategies to avoid or minimize critical HOS changes during manufacturing and storage.
In line with your needs, we adapt and, where required, qualify (according to ICH guidelines) our platform methods, tailoring them to your drug substance, its formulation matrix and your specific analytical questions – from comparability and biosimilarity to stability and process changes.
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist.
