Our cytokine release assay uniquely presents low donor variability, low background and cytokines measurements performed after only 4 hours (predicting immediate cytokine release).
When a biological drug such as a therapeutic monoclonal antibody is administered, it may react with different components of the human blood. These first infusion reactions are a result of activation of a variety of immune cells. The subsequent release of different cytokines can be severe and life-threatening, but can be managed with administration of steroids prior to drug administration, adjusting the infusion time or by adjusting the dose.
Our cytokine release assay provides a comprehensive tool to measure blood/drug interactions. Table 1 compares our assay with alternative in vitro assays for analysis of cytokine release, showing that our assay is the only available assay with intact cascade systems, short incubation time and it is also highly suitable for investigating drug biodistribution, efficacy and mode-of-action of biological drugs. Figure 1 shows a cytokine release to a panel of monoclonal antibodies used clinically and/or as a standards in cytokine release assays evaluated in our human whole blood loop assay.
As an example of the power of our assay, we have tested a TGN1412-like antibody* and shown that this antibody, but not the isotype-matched control, induce a clear cytokine release. Read more about our study in Fletcher Int Immunopharmacol. 2017 Oct 27;54:1-11.
*TGN1412 was an anti-CD28 monoclonal antibody that caused catastrophic systemic organ failure due to cytokine release in healthy volunteers in a clinical trial some 10 years ago.