Over the years we have developed a range of customized, product specific, potency assays in accordance with US Food & Drug Administration (FDA) and the European Medical Agency (EMA) standards, as well as guidelines issued by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Our BioPharma Efficacy team specializes in the characterization of monoclonal antibodies, hormones, and cytokines. We also have extensive experience working with biosimilars or modified biologics, such as pegylated products. Our BioPharma Safety assays are designed to help you mitigate off-target interactions of your drug candidate and to achieve optimal specificity from your new drug.
Contact us to learn more about our assay development and testing services and how we can help you bring safe and effective drug products and biologics to market.