Rabbit Pyrogen Testing

Pyrogens are fever-producing agents such as bacterial endotoxins and chemicals. As the administration of substances containing pyrogens can lead to shock, fever or death, parenteral products are required to undergo testing to confirm the absence of these agents. We currently utilise the rabbit pyrogen bioassay for the detection of pyrogens, as it is an official pharmacopoeial requirement for parenteral products in most countries.

Some of the in vivo pyrogen testing has been replaced by the in vitro Limulus Amebocyte Lysate (LAL) test, which we also offer in house.  There remain, however, some toxins that cannot be detected via this in vitro model and some molecules which are incompatible with the test system. In these cases, pyrogen testing may still be required to ensure the safety of the product.

We have also recently verified the Monocyte Activation Test (MAT), which is our newest in vitro alternative for the assessment of pyrogenicity of pharmaceutical products and medical devices.

At Wickham Laboratories, we are committed to reducing, refining and replacing testing in laboratory animals and have a dedicated in vitro team investigating viable alternative methods for these types of testing.

For more information regarding our commitment to laboratory animal welfare, please visit the links in the sidebar.