Description
Assay Performance Data
Accuracy and precision are critical to bioassays and the development of biologics. This assay was developed and prequalified according to ICH guidelines for accuracy and precision, giving it the performance characteristics required for many applications of a bioassay used for antibody drug discovery research and development. Accuracy: Measure of how close results are to a reference or "target" value. IntraLab Precision: Measure of repeatability from multiple assays of the same homogeneous sample under the same operating conditions over a short time (same analyst; same lab; same day). Intermediate Precision: Measure of repeatability of multiple assays of the same homogeneous sample with different analysts or equipment or on different days. Linearity: Ability of the assay to provide measured values that are proportional to the concentration of the sample.
The IL-12 Bioassay Shows Precision, Accuracy and Linearity.
The IL-12 Bioassay responds to recombinant IL-12.
IL-12 Bioassay Cells were prepared as described in the protocol and incubated with serial dilutions of recombinant IL-12. After a 4-, 5-, 6- or 24-hour incubation, Bio-Glo™ Reagent was added, and luminescence was quantified using the GloMax® Discover System.
The IL-12 Bioassay indicates stability.
Ustekinumab was heat treated at 65°C for 0–6 hours prior to use in the IL-12 Bioassay. Bio-Glo™ Reagent was added, and luminescence was quantified using the GloMax® Discover System.
