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 ADCP Reporter Bioassay (THP-1) Shows Precision, Accuracy and Linearity.
Representative data for the ADCP Bioassay (THP-1). Panel A. ADCP Reporter Bioassay Effector Cells (THP-1) were incubated with serial dilutions of Control Ab, Anti-CD20, or trastuzumab (Anti-HER2) in the presence of Raji target cells (CD20+/HER2−). Panel B. ADCP Reporter Bioassay Effector Cells (THP-1) were incubated with serial dilutions of Control Ab, Anti-CD20, in the presence or absence of Raji target cells. After a 4-hour incubation at 37°C, 5% CO 2 , Bio-Glo-NL™ Reagent was added and luminescence was quantified using the GloMax® Discover System. Data were fitted to a four-parameter logistic curve using GraphPad Prism® software. Data were generated using thaw-and-use cells.
