Endotoxin removal and prevention for pre-clinical biologics production

Abstract

The removal of endotoxin from protein solutions and its prevention are key to the success of recombinant protein production due to the possible pyogenic response in mammals caused by contaminated samples. In the pre-clinical situation, protein production is often carried out in a non-good manufacturing practice (GMP) setting, utilizing bacterial DNA for transient transfection and non-validated cleaning techniques. Here, we present our findings evaluating various options for endotoxin removal, and propose strategies for endotoxin prevention with emphasis on chromatographic separations, endotoxin-removing membranes and on-column wash strategies. © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.