Challenges in Endotoxin Recovery

Endotoxins (also called lipopolysaccharides) are a major component of the outer membrane of Gram-negative bacteria and cause a strong immune response in animals. If they contaminate pharmaceuticals that are administered by injection or medical devices that come into contact with the patient's bloodstream, endotoxins can trigger fever, sepsis or any other serious illness. It is therefore essential that each batch of these pharmaceuticals and medical devices be screened for the presence of such pyrogens.

There is a range of tests available for the detection of endotoxins, including the rabbit pyrogen test (RPT) and tests based on the limulus ambrocyte lysate (LAL), which is derived from the blood cells of crab- grass. The sensitivity, reliability and ease of use of the LAL test make it the preferred method in most laboratories. However, an inhibitor phenomenon known as Low Endotoxin Recovery (LER) has raised questions about its use and has caused considerable concern in the industry.

 

 

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