Detection Of Endotoxin And Non-Endotoxin Pyrogens By MAT

An Interview With Anne Connors, Senior Field Marketing Manager BioMonitoring, MilliporeSigma and Lamin Jallow, Microbiology Applications Scientist, MilliporeSigma

Pyrogens are substances that induce a rise in the body temperature of a human being or an animal, to the point of becoming a health concern. The pyrogens that contaminate pharmaceutical products most frequently are lipopolysaccharides (LPS), also known as endotoxins, which are major components of the outer membrane of Gram-negative bacteria. Endotoxins constitute a subgroup of pyrogens, albeit the most relevant one for the safety of pharmaceuticals. This is why all other pyrogens are collectively referred to as non-endotoxin pyrogens, a heterogeneous group in terms of chemical structure. However, such non-endotoxin pyrogens can pose risks to patient safety as well. Testing parenteral drugs for the most significant group of pyrogens (i.e., endotoxins) is crucial, and testing them for all types of pyrogen is elevating patient safety to a higher level.

Continue reading to learn more about regulations regarding the detection and elimination of pyrogens has evolved over the years as well as a robust and sensitive system that is a non-animal-based method for the detection of endotoxin and non-endotoxin pyrogens.