Endotoxin Testing (LAL)

 Endotoxin Testing (LAL)

Lipopolysaccharides (LPS) are bacterial endotoxins, and are components of Gram-negative bacterial walls known to cause fevers and diseases. Endotoxin testing of biologicals manufactured in bacteria is a necessity to ensure that the therapeutic product is endotoxin free. We offer endotoxin services at a several stages in the drug manufacturing and production process including:

Bulk Lot Release Testing

Final Product Release Testing

Raw Material Testing

Limulous amoebocyte lysate (LAL) is the test performed as this is based in the biology of the horseshoe crab which produces LAL enzymes in blood cells to bind and inactivate endotoxin from invading bacteria. This was accepted by the US FDA as an endotoxin test method in 1983. USP requires pooled testing of a production lot for the presence of bacterial endotoxin.

LAL - endotoxin tests with a variety of assay options including:

Quantitative and qualitative testing

Gel-clot method (LAL test)

Chromogenic methods (USP Chromogenic)

The Gel-clot method and the chromogenic method are approved for all phases of therapeutic product development. It is appropriate for multiple types of therapeutics including monoclonal antibodies, vaccines, recombinant proteins, cell therapy and gene therapy.

The gel clot test with the LAL test is for endotoxin detection only with GMP format typically being used for lot release testing of final products for injection in humans. The USP chromogenic method is based on the activation of a serine protease (coagulase) by the endotoxin, which is the rate-limiting step of the clotting cascade. This is a quantitative method and measures the activation of the serine protease as opposed to the end result of this activation, which is clotting.

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