Performance Data

iLite® RANKL Performance Data

The iLite® RANKL assay is ideal for potency measurements of anti-RANKL candidate drugs and studies of RANKL or RANKL agonists. As an added benefit, the RANKL iLite assay contains a luciferase normalization gene which can be used to compensate for differences in cell number and viability as well as serum matrix effects.

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

The iLite® RANKL assay is ideal for potency measurements of anti-RANKL candidate drugs and studies of RANKL or RANKL agonists. As an added benefit, the RANKL iLite assay contains a luciferase normalization gene which can be used to compensate for differences in cell number and viability as well as serum matrix effects.

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

The cell-based iLite®  RANKL 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 RANKL and the quantification of RANKL.

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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