Endotoxin removal and prevention for pre‐clinical biologics production

• DOI: 10.1002/biot.201200220
• Publication Date: 2012-10-19T11:01:07Z
• Authors: Anne Serdakowski ...; Brendan Kerins; William R. Tschantz; Kasey Mackay
• Keywords: Endotoxins; 0301 basic medicine; Biological Products; 0303 health sciences; 03 medical and health sciences; Drug Industry; Escherichia coli; Humans; Recombinant Proteins; Biotechnology; Chromatography, Liquid

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