Regulatory agencies like FDA or EMA expect a protein-based biologic to be characterized by determining its physicochemical properties, biological activity, immunochemical properties, purity and impurities. Especially the evaluation of the biological properties is, besides the safety, the most important critical quality attribute (CQA) of a biopharmaceutical drug or therapy.
Therefore, biological activity is essential for predicting the specific ability of a product to generate a particular biological effect and is furthermore fundamental for comparability studies of biosimilar products. Biofidus offers a variety of functional assays like surface plasmon resonance (SPR), customized enzyme-linked immunosorbent assays (ELISA) or cell-based assays to determine the biophysical properties as well as biological activity of your biologic or biosimilar.
The insights gained from these studies not only provide necessary knowledge about your product efficacy, quality and safety, but also guides the development and improvement of process control strategies 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.
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We‘ll advice you to define your assay needs