Endotoxin testing: past and contemporary methods, ecological impact, and developing of alternatives

Abstract

In the biotechnology industry, endotoxin testing is a ubiquitous procedure that has a fascinating history. It has impacted not only patients, but also the environment, and has the potential to be improved upon in the future. It is crucial that any drugs introduced to the body maintain a high degree of sterility, lest the drug designed to save a life is the cause of a different life-threatening disease. The predominant method used today is Limulus Amoebocyte Lysate, commonly referred to as LAL, which uses horseshoe crab blood. Since LAL is obtained by harvesting the blood of live horseshoe crabs, there is an ecological impact that comes with this type of endotoxin testing. Endotoxin testing with LAL is a vital and effective method of ensuring the safety of drug products, but it is a limited resource. Because of its necessity, it is pertinent that we develop alternatives to LAL in case it is no longer a viable option. Any alternatives should have an efficacy similar to that of LAL, but should not depend as heavily on harvesting the blood of horseshoe crabs since it is unsustainable in the long term