Pyrogen testing defines a process used by drug manufacturers to determine the limitation of an acceptable level of febrile reaction in the patient to the administration. The most commonly used form of pyrogen test is to inject drugs into rabbits intravenously and measure the rise in temperature of rabbits. Typically, pyrogenic substances include microbes or their metabolites. Vaccines and other injectable drugs must be confirmed to be pyrogen free according to regulatory requirements of 21CFR, USP<151>, and EP.
The process of pyrogen testing typically involves several rabbits at a time within a 10-minute time, and drug is injected into ear veins of rabbits. The dosage for each rabbit depends on body weight, age, and gender. Lastly animals' rectal temperatures are recorded every 30 minutes until three hours later, if a fever does not develop, the solution is judged to be from toxins.
Advantages:
- It can be replicated and demonstrate the production of fever in humans
- Detects all kinds of injectable pyrogen unlike LAL test
Disavantages:
- Time consuming
- Expensive procedure
- It is pass/fail test than assay
- It cannot be used to test certain drugs that depresses the fever
- Tolerance to certain class of drugs and biological variation can develop in rabbits
A new pyrogen test technique, named as limulus amoebocyte lysate (LAL) test, has also been developed by scientists from Creative Proteomics. LAL is an aqueous extract of blood cells (amoebocytes) from the horseshoe crab, and reacts with toxin in drugs or medical raw materials. The LAL pyrogen testing could be 100 times more sensitive than the rabbit testing procedures.
Creative Proteomics offers general safety test, including rabbit pyrogen testing, LAL test and any other custom-made services to detect toxic contaminants, please contact our experienced and knowledgeable experts for more detailed information.
