Biological Background

The cAMP Hunter™ Liraglutide Bioassay Kit provides a cell-based solution for liraglutide drug testing and quality control. This qualified bioassay enables precise liraglutide potency measurement and neutralizing antibody detection using CHO-K1 cells overexpressing human GLP-1 receptors. The assay leverages EFC technology for sensitive cAMP detection.

This bioassay kit serves companies developing GLP-1 receptor agonist therapies for diabetes and metabolic disorders. Applications include drug characterization, lot release testing, stability studies, and neutralizing antibody screening. The ready-to-use format accelerates results while ensuring consistency.

This kit has been optimized with Victoza® to meet regulatory requirements, providing validated parameters including accuracy, precision, linearity, and robustness for regulatory submissions and QC programs.

Product Highlights
  • Qualified bioassay with comprehensive validation data including accuracy, precision, and robustness parameters
  • Optimized and qualified with Victoza® (liraglutide) ensuring reliable potency measurement and NAb detection
  • Ready-to-use cryopreserved CHO-K1 cells overexpressing human GLP-1R with EFC detection technology
  • Complete kit includes cells, detection reagents, plating reagent, control agonist (exendin-4), and assay plates
  • Proven performance with inter-plate precision of 8.6% RSD and 98.4% accuracy across analytical range

cAMP Hunter Liraglutide Assay Principle

In the cAMP Hunter™ Liraglutide Bioassay Kit, CHO-K1 cells overexpressing human GLP-1R utilize the receptor's natural Gαs coupling to monitor activation. When activated by liraglutide, the receptor stimulates adenylyl cyclase, catalyzing ATP conversion to 3′-5′ cyclic adenosine monophosphate (cAMP). The resulting increase in intracellular cAMP is quantified using a homogeneous, gain-of-signal competitive immunoassay based on Enzyme Fragment Complementation (EFC) technology. Signal intensity correlates directly with cellular cAMP levels, higher GLP-1R activation produces greater cAMP concentrations and larger assay signals.

cAMP Hunter Exenatide assay principle

cAMP Hunter Liraglutide Bioassay Kit Qualification data

The Liraglutide qualification package demonstrates comprehensive validation of the cAMP Hunter™ Liraglutide Bioassay Kit across critical performance parameters. Validation studies include inter-plate precision assessment (8.6% RSD), accuracy evaluation (98.4% recovery), plate uniformity analysis (EC80 and IC80 across entire plate), plate-to-plate variability (three plates over three days), slope consistency, relative potency assessment (50-150% range), and parallelism testing with two operators. All studies were conducted with Victoza® and documented by designated assay developer and qualifier personnel.

View qualification data