The use of E. Coli in the production of biologics leads to high endotoxin levels in the material
passed from upstream fermentation to downstream purification. There are several challenges in
removing that endotoxin to meet FDA standards, including endotoxin’s stability over a wide pH
range and the small size of endotoxin molecules. In this work, we test commercially available
products marketed at removing endotoxin and evaluate them for endotoxin reduction and yield.
The products tested are Mustang Q membranes, Sartobind STIC PA membranes, Proteus
endotoxin removal spin columns, and a Triton X-100 protocol. All products decreased the
endotoxin levels of the samples tested while producing good yield, but scalability, ease of use,
and product purity vary. We also simulate the endotoxin level of a process development lab
environment where bacterial fermentations are regularly performed to measure the baseline lab
endotoxin level and generally find a low level of endotoxin in the lab environment. Finally, we
test common NaOH cleaning procedures to quantify the reduction in endotoxin that may be
achieved in a real-life working lab environment.