Cell-based assays, irreplaceable?!

Regulatory agencies like FDA or EMA expect a protein-based biologic to be characterized by determining its physicochemical properties, bioactivity, immunochemical properties and purity. Especially the evaluation of the bioactivity is, besides the safety, the most important critical quality attribute (CQA) of a biopharmaceutical drug or therapy.

Particularly cell-based assays enable a realistic simulation of naturally occurring functionalities by providing dynamic data on cell vitality and their behavior. Biofidus offers a broad range of tailored cell-based assays for an in-depth characterization of functional and biochemical events like signal transduction, reporter gene activity, enzyme activity, antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated phagocytosis (ADCP), complement dependent cytotoxicity (CDC), vitality and cell proliferation. For assays with primary cells, we have access to human blood and are experienced with culture and differentiation of stem cells.

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 manufacturing. Our experienced scientists at Biofidus guide you in accordance with ICH guidelines and will provide you a suitable set of tailored cell-based assays for your individual demand.

Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist.