Project description
Towards more sustainable endotoxin testing
Bacteria produce lipopolysaccharides, which may induce strong immune reactions including fever and shock. This is why all pharmaceutical products undergo rigorous endotoxin or pyrogen testing. The gold standard method involves the reagent Limulus amoebocyte lysate (LAL), which is extracted from the horseshoe crab, Limulus polyphemus. The aim of the EU-funded LimuleX project is to address the growing demand for LAL in a sustainable manner. Using proprietary cell technology, researchers have succeeded in producing a bio-identical LAL reagent in an animal-free manner. Moreover, the LimuleX LAL reagent constitutes a better-quality product and is in line with the animal replacement, reduction and refinement principles.
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equation, modernizing the outdated supply chain and making a better quality product.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.
Fields of science
- natural sciencesbiological sciencesmicrobiologybacteriology
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- natural sciencesbiological sciencesbiochemistrybiomolecules
- social scienceseconomics and businessbusiness and managementbusiness models
- medical and health sciencesmedical biotechnologycells technologies
Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
T12 P1HX BLACKROCK CORK
Ireland
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.