Cell-Based Assays for 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 bioactivity, immunochemical properties and purity. Among these, biological activity is, alongside safety, one of the most critical quality attributes (CQAs) of a biopharmaceutical drug or therapy.
Cell-based assays (CBAs) are often the gold standard for assessing bioactivity because they can simulate natural biological functions in a relevant cellular context. They provide dynamic information on cell viability, signaling, effector functions and functional responses, making them indispensable for potency testing, stability studies, comparability and biosimilarity assessments.
At Biofidus, we offer a broad range of tailored cell-based assays for in-depth characterization of functional and biochemical events such as signal transduction, reporter gene activity, enzyme activity, internalization, antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), complement-dependent cytotoxicity (CDC), cell viability and cytotoxicity. For primary cell–based assays, we have access to human blood and are experienced in the culture and differentiation of stem cells, enabling physiologically relevant assay formats.
The insights gained from these studies provide essential information on product efficacy, quality and safety, and they also guide the design and improvement of process control strategies during manufacturing. Our experienced scientists design fit-for-purpose cell-based assay packages in line with ICH and regulatory expectations, tailored to your mechanism of action and development stage.
Get in contact with us to define the optimal cell-based assay strategy for your project and to speak directly from scientist to scientist.
