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Endotoxin removal and prevention for pre‐clinical biologics production
Author(s) -
Serdakowski London Anne,
Kerins Brendan,
Tschantz William R.,
Mackay Kasey
Publication year - 2012
Publication title -
biotechnology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.144
H-Index - 84
eISSN - 1860-7314
pISSN - 1860-6768
DOI - 10.1002/biot.201200220
Subject(s) - recombinant dna , chemistry , contamination , biology , biochemistry , gene , ecology
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.