PDA Letter Article

Five Critical Endotoxin Testing Concerns

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

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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.