Performance Data

iLite® IL-2 Performance Data

The iLite® IL-2 Assay Ready Cells are genetically engineered reporter gene cell line, optimized to respond to IL-2 with proportional 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 the control of a constitutive promotor. The IL-2 cells can be used for the quantification of IL-2 activity, or neutralizing antibody response against IL-2 in test samples, including human serum.

In this performance data file, we present data for the IL-2 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® IL-2 Performance Data

The iLite® IL-2 Assay Ready Cells are genetically engineered reporter gene cell line, optimized to respond to IL-2 with proportional 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 the control of a constitutive promotor. The IL-2 cells can be used for the quantification of IL-2 activity, or neutralizing antibody response against IL-2 in test samples, including human serum.

In this performance data file, we present data for the IL-2 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 IL-2 cell-based reporter gene assay

The cell-based iLite® IL-2 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 IL-2 and the quantification of IL-2.

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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