Bioactivity & Potency Testing
Regulatory agencies such as FDA and EMA expect every protein-based biologic to be characterized not only by its physicochemical properties, but also by biological activity, immunochemical properties, purity and impurities. Among these, bioactivity and potency are, next to safety, the most critical quality attributes (CQAs) of a biopharmaceutical drug or therapy.
Biological activity describes the specific ability of a product to trigger a defined biological effect. It is essential for dose selection, potency assignment, lot release and stability studies, and it is fundamental for comparability and biosimilarity assessments versus a reference product.
At Biofidus, we offer a wide range of functional bioactivity assays, including surface plasmon resonance (SPR), tailored cell-based assays, and ELISA formats, to characterize both the biophysical interactions and the biological activity of your biologic or biosimilar.
The data generated help you understand efficacy, quality and safety, and support the development and improvement of process control strategies throughout manufacturing.
In line with your needs, we adapt and, where required, qualify our platform methods according to ICH guidelines, tailoring them to your drug substance, its formulation matrix and your specific analytical questions, from early research to late-stage clinical development and lifecycle changes.
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist.
