Endotoxin Control In The Process Development Lab: From Upstream Bacterial Fermentation To Downstream Purification Processes

By Grace X Tan, Salvador Vazquez Reyes, Natalie Kay, Kady Oakley, Shawn Nie, and Dogan Ornek , Boston Institute of Biotechnology, 225 Turnpike Road, Southborough, MA 01772

Endotoxin in clarified E. coli lysate can exceed 1 billion EU/mL, and it has to fall by many orders of magnitude before a product meets the FDA threshold. Researchers at the Boston Institute of Biotechnology (Grace X Tan, Salvador Vazquez Reyes, Natalie Kay, Kady Oakley, Shawn Nie, and Dogan Ornek) tested four commercially available removal approaches on an enzymatic protein, weighing endotoxin reduction and yield against scalability, ease of use, and product purity. They also measured the endotoxin baseline of a working process development lab and tested how well common NaOH cleaning procedures reduce it on tubing and chromatography systems. The results raise a practical question about when environmental contamination starts to matter in a purification run.

Explore the data and see how the methods compared.