PDA Letter Article

Five Critical Endotoxin Testing Concerns

by Jennifer Farrington, PhD, Associates of Cape Cod, and Friedrich von Wintzingerode, PhD, Roche Diagnostics GmbH


As pharmaceutical manufacturing processes continue to become more streamlined and therapy delivery continues to evolve, so has endotoxin control. Five topics in particular have dominated recent discussions around endotoxin control: low endotoxin recovery, non-LAL detection methods, modulating impurities, data integrity and depyrogenation.