The iLite® TNF-alpha Assay Ready Cells provide a means of directly quantifying both the potency and neutralizing antibody response to TNF-alpha antagonists of diverse structure in the same assay, making it an outstanding tool for biosimilar development.
Measuring the functional activity of TNF-alpha, the assay can be used for both potency and immunogenicity assessments of TNF-alpha inhibitors in the same assay and the iLite TNF-alpha assay ready cells also provide a means of directly comparing a biosimilar and innovator product in the same assay.
The iLite TNF-alpha cells are engineered cells for use in a normalized reporter gene bioassay for screening of anti-TNF alpha activity in samples. The assay is a simple and easy test format which detects anti-TNF alpha activity and, indirectly, the presence of anti-drug antibodies.
iLite TNF-alpha cells are a genetically engineered reporter gene cell line of human origin (K562), responsive to tumor necrosis factor alpha (TNF-alpha), resulting in the specific expression of Firefly Luciferase. Normalization of cell counts and serum matrix effects is obtained by a second reporter gene, a Renilla Luciferase reporter gene construct, under control of a constitutive promotor.
