A challenge that confronts drug manufacturers is that bioassays are inherently variable because they rely on biological materials that can change over time, thus impacting assay results, that’s why biological assays (also called bioassays) are an

integral part of the quality assessment required for many biological and some non-biological drug products, and are often used to assign potency. USP® offers many product-specific bioassay reference standards that can be used by manufacturers of biologics and other complex molecules to either assign relative potency, detect shifts in potency values when using in-house standards, or to ensure bioassay results do not drift when any critical reagent changes. Welcome to contact ours specialist for more details, or explore at www.usp.org/biologics/bioassays