Performance Data

iLite® FGF21 Performance Data

The hormone fibroblast growth factor 21 (FGF21) holds considerable promise as a therapeutic mechanism and understanding the physiology and the pharmacology of FGF21 is key to all drug development projects related to this field.

In this performance data file, we present data for the FGF21 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® FGF21 Performance Data

The hormone fibroblast growth factor 21 (FGF21) holds considerable promise as a therapeutic mechanism and understanding the physiology and the pharmacology of FGF21 is key to all drug development projects related to this field.

In this performance data file, we present data for the FGF21 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.

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The most common bioanalytical aspects of the iLite FGF21 cell-based reporter gene assay

The cell-based iLite®  FGF21 assay is a cleverly designed, sensitive, and specific reporter-gene assays with firefly luciferase readout and has been used with great success by companies working to develop new multi-modal drugs.

The assay allows an easy, rapid, and accurate test format for a wide range of applications – including the determination of neutralizing antibodies against FGF21 and the quantification of FGF21.

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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