Safety Assays

Although the body’s immune system functions effectively to restore homeostasis after a biological or physical insult, the protective mechanisms can become detrimental when over activated. This is often seen when new pharmaceuticals or medical devices intended to promote healing are introduced in to the body but cause unintended over activation of the immune system. Increased expression of pro-inflammatory cytokines or excessive cellular proliferation is often seen in the activated immune response. The importance of assessing the inflammatory response in humans was emphasized after the failure of animal models to predict the resulting cytokine release in human subjects in the TGN1412 phase I clinical trial resulting in a life threatening “cytokine storm” in the six trial subjects.