What Are Endotoxins and Why Are They a Top Priority in Drug Manufacturing?
Endotoxins are a type of harmful substance that can be found in the outer membrane of certain bacteria. If these substances get into a drug product and are administered to a patient, they can cause a severe immune response, including fever, inflammation, and in extreme cases, septic shock. This is why testing for endotoxins is one of the most critical steps in the production of injectable drugs, medical devices, and biologics. For decades, the primary method for this test involved the use of horseshoe crab blood, but today, advanced technologies like recombinant Factor C (rFC) are providing a more sustainable and precise alternative. The rigorous and continuous testing for endotoxins highlights the extreme caution the biopharmaceutical industry takes to ensure product purity and patient safety. It is a fundamental and dominant segment within the growing Biologics Safety Testing Market.