LimuleX

Project "LimuleX" data sheet

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 Project objective

A pyrogen is a fever inducing substance when introduced or released into the bloodstream, typically produced by a bacteria. Bacterial endotoxins are lipopolysaccharides present in the cell walls of Gram-negative bacteria. Pyrogen testing is a fundamental necessity in quality control for product safety in the regulated biomedical industries. For example, parenteral preparations have to be pyrogen-free because administration of pyrogens may induce fever, shock or even death. The severity of the adverse reaction depends on the concentration and biological activity of the respective pyrogen. The gold standard and de facto industry norm for pyrogen tests is a reagent called LAL (Limulus Amoebocyte Lysate). However, for the past 60 years, the sole source for making LAL has been the blue blood of the Atlantic Horseshoe Crab. Even at current harvest rates, the product is unsustainable. Demand is forecast to more than double in the next 5 years. Moreover, there are longstanding challenges in the upstream side of the LAL supply chain. Sothic produce a bio-identical LAL using proprietary cell technology. This removes the declining animal source from the equation, modernizing the outdated supply chain and making a better quality product. Sothic replace the use of unsustainable animal-derived reagents with scalable production of high-quality biomolecules.