Wickham Laboratories are excited to announce their most recent publication on “The Importance of Testing for Pyrogens in Raw and In-Process Materials”, written by Section Head of Endotoxin and Cytotoxicity Testing, Sophie Bell.
The article, published by International Biopharmaceutical Industry (IBI) in their December issue, discusses the effects pyrogens can have on humans and focuses on the three different methods used to test for pyrogens as well as why such testing is compulsory within the pharmaceutical and medical device industry.
An excerpt of this article as follows:
Pyrogens are substances that can induce shock, fever or death with the most common type of pyrogen being the gram-negative bacteria-derived lipopolysaccharide or endotoxin.
There are currently three approved methods for the testing of pyrogenicity; the rabbit pyrogen test (RPT), the bacterial endotoxin test (BET) using limulus amoebocyte lysate (LAL) and the monocyte activation test (MAT). Both the BET and the MAT were developed to replace the rabbit pyrogen test in effort to reduce the number of animals used in pyrogen testing.
If you are interested in reading the digital version in full, please visit the IBI website or a copy can also be requested directly from Wickham Laboratories.
As a GMP/GLP compliant laboratory with over 50 years of experience, Wickham Laboratories Ltd is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy. We conduct business with clients worldwide and the combined expertise of our laboratory technicians and managers enables us to be fully conversant with global regulatory expectations.
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