Removal of Endotoxins – From Bench to Process Scale

Endotoxins or lipopolysaccharides (LPS) are highly toxic components of the cell wall of Gram-negative bacteria, which are often present in significant amounts in bacterial cell expression systems such as E.coli. A number of methods have been adopted for the removal of endotoxin based on adsorption, in particular ion exchange chromatography. Although downstream processing can significantly reduce endotoxin levels in the product, efficient and cost effective removal of residual endotoxin from biopharmaceutical preparations remains a challenge. Prometic Bioseparations have developed an affinity chromatography adsorbent, EtoxiClear™, that is highly stable, robust and non-toxic, with a high affinity for bacterial endotoxin and low protein binding. EtoxiClear™ is a cost-effective and scalable technology designed for use in endotoxin removal applications including process development, sample/buffer preparation and product polishing steps used during cGMP manufacture of biological molecules. This application note describes the use of EtoxiClear™ to effectively remove endotoxin from a purified immunoglobulin protein solution at bench scale using the EvolveR™ column, and at process scale with the EvolveD™ column.