Endotoxins are the structural component of lipopolysaccharide (LPS) of the cell wall of Gram-negative bacteria. They are mainly composed of O-antigen, core oligosaccharide, and lipid-A molecules. The presence of lipid-A in the bloodstream can cause cell apoptosis, and a large amount of Lipid-A will also produce various toxic effects, including fever, diarrhea, vomiting, and potentially fatal septic shock.
Since endotoxin can exist widely and stably in nature, and has potent toxicity, any injectable or implantable products that are labeled as pyrogen-free or sterile must undergo reliably and effectively testing for bacterial endotoxin. Indispensable in the pharmaceutical and biomedical industries, bacterial endotoxin testing (BET) is considered a basic safety requirement in these industries, and these quality control (QC) tests must comply with regulatory requirements enforced by the European and US Pharmacopoeias and US food and Drug Administration. Currently, the most comprehensive and widely used bacterial endotoxin test is the limulus amebocyte lysate (LAL) test, which has replaced the rabbit pyrogen test (RPT) and is considered a more sensitive and specific BET test.
The LAL test is formulated using specialized blood cells (amebocytes) obtained from the blue blood of the Atlantic horseshoe crab. They are the only immune defense system of the crab: the blood coagulation system. After encountering foreign substances like endotoxins, amoebocytes will produce clots to immobilize and kill pathogens. And the reaction is very sensitive, even minimal amounts of endotoxin can trigger this immune response.
We offer LAL assays (including gel clot LAL assay, turbidimetric LAL assay, and chromogenic LAL assay) and non-animal-derived recombinant Factor C (rFC) assay services. Customers can consult our researchers to obtain the most suitable LAL test program to meet their application needs.
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