The Swedish immunoassay company Mercodia developed a novel assay for the detection of the insulin analogue lispro in serum.
“Insulin lispro is widely used as a comparator, for efficacy and safety assessment, in biosimilar development during the course of its clinical development program to determine whether the generic drug performs as the brand drug. Insulin lispro is also used as a fast-acting insulin for glycemic control in diabetic patients,” Hanna Ritzén, managing director of research and development for Mercodia, told Endocrine Today. “To monitor and differentiate insulin lispro from other insulins will improve the outcome in drug development and clinical studies.”
As Ritzén explained, there is a need to differentiate Lispro, which has been used since 1996 to treat diabetes, from endogenous insulin and other analogues at both the research and pharmaceutical levels. Mercodia’s new assay, Lispro NL-ELISA, was designed to accomplish that goal. The assay features six pre-diluted calibrators and, according to Mercodia, meets EMA and FDA validation requirements. The company also stated in a press release that the new assay relies on chemiluminescence detection and does not require pre-treatment or dilution of samples.
“Up until now there has not been a commercial method available that is highly sensitive, specific to lispro, that requires low sample volume and gives high throughput,” Ritzén said. “Insulin lispro differs only by two amino acids compared to endogenous insulin, reversal of the proline at B-28 and the lysine at B-29, which is why it has been hard to develop specific antibodies against lispro.” – by Phil Neuffer
Disclosure: Ritzén reports she is an employee of Mercodia.