Under Mikkelsen’s leadership, Scan Dia Labs specialized in the ultra-sensitive, quantitative kinetic-turbidimetric LAL assay, one of several LAL methods recommended by pharmacopoeias like the United States Pharmacopeia (USP) and European Pharmacopoeia (EP). This technique measures the turbidity (cloudiness) caused by the gelation reaction between LAL and endotoxins, providing a precise quantification of endotoxin levels down to sub-picogram concentrations. The lab’s expertise extended to mastering all LAL assays, ensuring compliance with regulatory standards, such as those outlined in the U.S. FDA’s 2012 “Guidance for Industry: Pyrogen and Endotoxins Testing.” Scan Dia Labs, authorized by the Danish Health and Medicines Authority and regularly audited by international clients, became a cornerstone in the global effort to ensure product safety through reliable endotoxin detection.
 

Mikkelsen’s contributions helped solidify the LAL test’s status as the gold standard for bacterial endotoxin testing, replacing earlier methods like the rabbit pyrogen test, which was less specific and more cumbersome. His work at Scan Dia Labs not only advanced the technical capabilities of endotoxin testing but also supported its widespread adoption in pharmaceutical quality control, protecting patients from the risks posed by contaminated products. Today, the legacy of his efforts continues to influence modern testing practices, even as new technologies, like recombinant alternatives to LAL, emerge.