Adding value to cytokine release assays by combining analytical techniques and enhanced data analysis

Introduction:

Induction of cytokines, termed ‘cytokine storm’ is a common consequence of the administration of therapeutic antibodies. The worst occurrence being in 2006 when the administration of TGN1412 to subjects in a Phase I trial resulted in unprecedentedly high levels of cytokine release, leading to hospitalization of the subjects with systemic organ failure. This has led to a drive to produce ex vivo assays capable of indicating whether a novel therapeutic antibody would present a significant risk for cytokine release. Such assays have become widely used tools in early stage drug candidate screening, and are integral to the CTA process.

We present data from antibodies suitable to use as comparative controls for novel candidate drugs as they elicit a range of cytokine responses. We have combined measurement of the most commonly evaluated cytokines with ex vivo cellular analysis and demonstrate a novel data analysis approach for the often large and multi-parameter datasets generated.

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