Ex Vivo Glucagon Bioidentity Test – USP <123>
Glucagon – A Prescription Drug
Glucagon is a critical drug for the treatment of severe hypoglycemia (low blood sugar). It has the opposite effect of insulin, a drug usually prescribed for patients with diabetes. Glucagon is a peptide hormone that stimulates the hepatocyte cells to convert glycogen to glucose, hence increasing blood sugar levels.
Glucagon Bioidentity Assay
The glucagon bioidentity bioassay is often used as a lot release assay. It is an ex vivo procedure utilizing a primary culture of rat hepatocyte cells. An ex vivo procedure involves the harvest of cells or tissue from an animal. These cells or tissue are then cultured and used to assess the activity of a test article. Pacific BioLabs has performed cGMP USP glucagon bioassays for over 15 years and is one of the few CROs performing this assay.
Glucagon Bioidentity Assay – Procedure
To perform the assay, liver cells are removed from a rat to create a primary culture. The test article is then applied to this culture. 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.