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 4-1BB Bioassay Shows Precision, Accuracy and Linearity.
The 4-1BB Bioassay reflects mechanism of action and shows specificity of biologics designed to activate 4-1BB. Panel A. 4-1BB Effector Cells were induced with a serial titration of ligands: GITRL, 4-1BBL and OX40L as indicated. Panel B. 4-1BB Effector Cells were induced with a serial titration of Control Ab, Anti-GITR (Cat.# K1171), Control Ab, Anti-4-1BB (Cat.# K1161), and Control Ab, Anti-OX40 (Cat.# K1191), as indicated, in the presence of FcγRIIb CHO-K1 Cells (Cat.# JA2251, JA2255). For both panels, Bio-Glo™ Reagent was added, and luminescence was quantified using the GloMax® Discover System.
