Measuring the functional activity of TNF-α, the assay can be used for both potency and immunogenicity assessments of TNF-α inhibitors in the same assay. As such, the iLite TNF-α Assay Ready Cells also provide a means of directly comparing a biosimilar and innovator product in the same assay.
In this performance data file, we present data for the TNF-α cell line generated throughout the quality assessment process of the product. This data shows that the assays are reliable, accurate, and reproducible - and helps keep errors resulting from biological variation and methodology at a minimum.