Ex Vivo Glucagon Bioidentity Test – USP <123>
Glucagon is a critical drug for the treatment of diabetes. The glucagon bioidentity assay is an ex vivo procedure utilizing a primary culture of rat hepatocyte cells. Pacific BioLabs has performed cGMP USP glucagon bioassays for over 15 years and is one of the few CROs performing this assay.
To perform the assay, liver cells are removed from a rat to create a primary culture. Glucagon is a peptide hormone that stimulates the hepatocyte cells to convert glycogen to glucose. The release of glucose can be measured using a Siemens Dimension Xpand Plus Chemistry System. By comparing the biological activity of the Glucagon reference standard with the product being tested the potency can be calculated and in order to meet the requirements of the bioassay, the glucagon product being tested must have a potency of 0.80 USP rGlucagon Units/mg and must not show dose-response reversals at the 25, 50, or 100 µUnits/mL does levels.
The glucagon bioidentity bioassay is often used as a lot release assay.