Endotoxin contamination and its adverse effects on human beings is a very important topic for the biotech manufacturing and formulation industry as well as medical device specialists and biomaterial scientists. When introduced into the bloodstream, endotoxins activate the immune system, resulting in the release of mediators, such as tumor necrosis factor, several interleukins, prostaglandins, colony stimulating factor, platelet activating factor, and free radicals having potent biological activity for adverse effects. Any superfluous endotoxin exposure must be strictly avoided to prevent complications, especially with intravenous medications. Endotoxin testing has therefore become an important part of the quality assessment of pharmaceutical preparations.

Most peptide drugs are delivered to patients via parenteral methods (injection). Endotoxin contamination of peptide can occur as a result of poor cGMP controls. Qualification, validation, and monitoring of process, equipment, water, and other controls are crucial for preserving product quality and integrity in cGMP manufacturing of peptides.

This cleanroom tip was taken from “Controlling Endotoxin Contamination During Peptide Manufacturing,” which appeared in the November/December 2012 issue of Controlled Environments.