Mastering Low Endotoxin Injectable Drug Development: Critical Control Strategies In A High Stakes Domain
Endotoxin control is one of the most demanding and consequential aspects of injectable drug development. Endotoxins (heat-stable lipopolysaccharides originating from the outer membrane of Gram-negative bacteria) pose unique challenges due to their persistence, their resistance to sterilization, and their ability to trigger severe pyrogenic reactions even at trace levels. For…