A pyrogen is a chemical that activates the innate immune system, causing an increase in temperature (fever reaction) in a human or animal. They are a diverse collection of pollutants that include both microbial and non-microbial compounds. There are two types of pyrogens: endotoxins and non-endotoxin pyrogens (NEPs). Gram-negative bacteria produce endotoxins, which are toxic chemicals. Other microbial compounds, such as those obtained from Gram-positive bacteria or viruses, as well as pyrogens derived from yeasts and fungi, are non-endotoxin pyrogens. Rubber particles, microscopic plastic particles, and metal compounds in elastomers can all produce non-microbial pyrogenic chemicals.
According to the “Coherent Market Insights” Global Industry Insights, Trends, Outlook, and Opportunity Analysis of Pyrogen Testing Market.
Pyrogen testing is important in modern healthcare since it identifies the presence of pyrogen in a fever-causing bacterium. Lipopolysaccharides and lepoteichoic acid include pyrogen. Contaminated pyrogenic goods can induce hazardous side effects in humans, such as fever.
Pyrogen testing is used to determine the presence of pyrogens in pharmaceutical dosage forms and medical devices. Temperature dysregulation, bodyache, inflammation, shock, multiorgan failure, and other life-threatening issues can result from pyrogen-contaminated injections after they have been administered.
Pyrogen Testing Services
For over 30 years, we’ve been doing in vivo pyrogen testing with speed and accuracy, providing quick sample turnaround and technical competence. We use our own specific-pathogen-free rabbits in our specialised Good Manufacturing Practices compliant facilities to undertake this crucial component of our clients’ quality control programme. Protein-based, non-protein, and blood-based materials are among the test items. Both IMPs and approved medicinal products can be tested for pyrogenicity.
When testing for non-endotoxin pyrogens and other products for which LAL is insufficient, the rabbit pyrogen test (RPT) remains a suitable mammalian test paradigm. Regulatory authorities may also need one-time pyrogen testing to support endotoxin testing routinely. All in vivo rabbit pyrogen assays follow the USP, European, and/or Japanese Pharmacopeia.
