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A bio-identical and non-animal replacement for the quality control reagent of pyrogen testing in the medical and pharmaceutical industries.

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equation, modernizing the outdated supply chain and making a better quality product.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.

Call for proposal

H2020-EIC-SMEInst-2018-2020

See other projects for this call

Sub call

H2020-SMEInst-2018-2020-1

Coordinator

SOTHIC BIOSCIENCE LIMITED
Net EU contribution
€ 50 000,00
Address
Buckley kiely heritage business park mahon industr estate
T12 P1HX Blackrock cork
Ireland

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Region
Ireland Southern South-West
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Other funding
€ 21 429,00