Endotoxin testing is a critical quality control procedure used in pharmaceutical, biotechnology, and medical device industries to detect and quantify endotoxins—lipopolysaccharides (LPS) found in the outer membrane of Gram-negative bacteria. These substances are potent pyrogens and can cause severe immune responses, including fever, sepsis, or toxic shock, if introduced into the human body through injectable drugs, vaccines, or implantable medical devices. The presence of endotoxins in these products poses a significant safety risk, making their detection an essential step in manufacturing.
There are several methods for endotoxin testing, with the most widely used being the Limulus Amebocyte Lysate (LAL) assay. Derived from the blood of the horseshoe crab, the LAL test is highly sensitive and can detect even trace amounts of endotoxins. Other techniques include the Monocyte Activation Test (MAT), which simulates human immune responses, and recombinant Factor C (rFC) assays, which eliminate the need for animal-derived components.
Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate strict endotoxin limits for various product categories, ensuring patient safety. Manufacturers are required to validate their testing methods, establish acceptable endotoxin levels, and perform routine testing throughout the production process. The development of non-animal alternatives and advancements in detection technologies continue to improve the efficiency, sensitivity, and sustainability of endotoxin testing, solidifying its role in safeguarding public health.