A whole blood in vitro cytokine release assay with aqueous monoclonal antibody presentation for the prediction of therapeutic protein induced cytokine release syndrome in humans

Article ID	Journal	Published Year	Pages	File Type
5897339	Cytokine	2012	10 Pages	PDF

Abstract

âº The ability of a whole blood assay to predict cytokine release in vivo was assessed. âº The assay correctly identified the hazard for several clinically relevant antibodies. âº Aqueous TGN1412 induced cytokine release in whole blood in vitro. âº Compared to a PBMC assay, we found low background and no false-positive results. âº Assay format selection must focus on target biology and in vivo relevant mechanisms.

Keywords

PBS QCs TNF mAb LLOQ PBMCs TGN1412 ULOQ PEI MSD Monoclonal antibody Cytokine release interferon IFN interleukin upper limit of quantification lower limit of quantification standard error of the mean cluster of differentiation Whole blood Room temperature peripheral blood mononuclear cells Coefficient of Variation tumor necrosis factor fragment crystallizable Phosphate-buffered saline SEM quality control samples Polyethylenimine Meso Scale Discovery