Biopharmaceuticals can exert their effect through many different mechanisms but often target endogenous pathways by enhancing or suppressing specific signaling molecules. To understand how these complex processes work, there is a need for an assay that can resolve the individual steps of the pathway in a relevant biological setting. Such assays are commonly referred to as Mechanism of Action (MoA)-reflective. It is not sufficient to know THAT it works, but HOW it works.

Traditional assays rely on primary cells that are isolated directly from a donor. Although these assays offer several benefits, there are clear disadvantages, such as the high variability associated with these cells and the difficulty of growing them.

In recent years, exciting and innovative new assay formats have emerged as important drug discovery tools. iLite® Functional Bioassays represent one of these new MoA-reflective technologies. They are based on a reporter gene system that offers a convenient and powerful way of measuring and quantifying drug potency, detecting NAbs, and assessing immunogenicity.