Performance Data

iLite® TNF-alpha Performance Data

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.

Performance Data

iLite® TNF-alpha Performance Data

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.

LEARN MORE ABOUT

The most common bioanalytical aspects of the iLite TNF-α cell-based reporter gene assay

The cell-based iLite®  TNF-α assay is a cleverly designed, sensitive, and specific reporter-gene assay with firefly luciferase readout intended to be used in various applications throughout the drug development continuum.

The assay allows an easy, rapid, and accurate test format for a wide range of applications – including the determination of neutralizing antibodies against TNF-α and the quantification of TNF-α.

Included chapters:

  • Cell line Characterization
    - Validation of manufacturing process & determination of the overall cell line variation
    - Real-time stability study
    - Dynamic range assay application example
    - Plate homogeneity
  • Bioassay variation & performance
    - Accuracy & variations – day-to-day
    - Accuracy & variations – lot-to-lot
    - Linearity (parallelism) functional / linearity (parallelism) inhibitory
  • Cell line bioassay pre-clinical & clinical applications
    - Immunogenicity characterization


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