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A pyrogen is a foreign substance that causes a fever (temperature elevation) in an animal’s body. Typically, pyrogenic substances include endotoxin and other bacterial byproducts. Vaccines and other injectable drugs must be confirmed to be pyrogen free according to regulatory requirements of 21CFR, USP, and EP.

The typical assay for endotoxin contamination detection is the LAL test. In some cases, the LAL test may not be feasible. These cases might include:

• Interference by the test article
• The presence of a compound capable of neutralizing endotoxins
• The presence of pyrogenic substances other than endotoxin,
• Certain regulatory requirements

BioReliance offers the rabbit pyrogen test, in addition to the LAL test, as an alternative assay for the detection of endotoxin and other pyrogens. The rabbit pyrogen test requires the injection of a small amount of batched test material into a rabbit’s blood stream, and monitoring for temperature increases.

Contact our experienced scientific staff to learn about more about rabbit pyrogen testing.

BioReliance also offers a general safety test to detect extraneous toxic contaminants.