The immunoassay company Mercodia is launching a new assay for detection of the insulin analog Lispro.
Uppsala 19-01-24: The immunoassay company Mercodia is launching a new assay for detection of the insulin analog Lispro. This easy-to-use, high quality PK ELISA meets the pharmaceutical industry requirements for multiple phases of drug development.
Insulin lispro is a rapid-acting insulin analog that was first introduced in 1996 to treat people with diabetes. In research projects, as well as pharmacological projects it is important to be able to differentiate the insulin analog lispro from endogenous insulin and other insulin analogs. To this end, Mercodia has developed a highly specific antibody with these properties.
“We wanted this assay to qualify as a PK assay, so we had to follow several requirements for assay design as well as analytical performance as specified in industry guidelines. In addition, differentiating lispro not only from other rapid- and long-acting insulin analogs, but also from endogenous insulin, is a need that demands careful method development”, said Hanna Ritzén, Managing Director, Research and Development at Mercodia.
This novel Lispro ELISA is both sensitive and specific for the determination of insulin lispro. With six pre-diluted calibrators as well as anchor points and three controls in serum matrix, as evidenced by the robust assay performance characteristics, this method meets the requirements of EMA and FDA validation. The assay uses chemiluminescence detection and displays no interference from insulin auto-antibodies, and therefore no pre-treatment or dilution of samples is necessary, saving time and samples.
“This new Lispro ELISA is validated for use on human as well as porcine plasma and serum. Porcine is an important animal model for studies on diabetes and its treatment, and we have designed our assay not to cross react with endogenous insulin or proinsulin. This makes it possible to use on healthy pigs, releasing researchers of the economical and time-consuming burden of having to use diabetic pigs in their projects”, Hanna Ritzén concludes.
Learn more about the Mercodia Lispro NL-ELISA here.
Notes to the editor
About Mercodia
Mercodia is a world-leading developer, manufacturer and distributor of high quality immunoassays in the areas of diabetes, obesity and cardiovascular disease. We offer assays and services applicable to both human and animal models. We service a global market of over 100 countries with immunoassays spanning nine different species, covering basic, preclinical and clinical research sectors. Read more at www.mercodia.com
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