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In vitro cytokine release assays: Is there calm after the storm?
One of the best documented cases of pharmaceutical-related cytokine release syndrome (CRS) is the TGN1412 clinical trial undertaken in 2006. This monoclonal antibody therapy, targeted against CD28 receptor was designed to treat hematological cancers and autoimmune disease. During preclinical safety testing, study findings indicated no serious adverse events, even while dosing at ~500x the safe clinical trial dose. These findings were not reflected in the clinical trial. Read more about cytokine release assays and how they can help you avoid future development challenges.