BioProcess International Poster Feature: EtoxiClear™: A New Adsorbent for the Efficient Removal of Endotoxin From Biopharmaceuticals

Last week, we put out a Call for Posters so that you could share your research and findings with your scientific community at the BioProcess International Conference this coming September 16-19, 2013, in Boston.  This week, we'll be looking at the two winning posters that were presented at the 2012 BioProcess International Event.  Monday, we featured Characterization of a Biomanufacturing Fermentation Process Using a New DOE Approach: Definitive Screening Designs.  Today, we feature the other winner of the BPI International poster contest.

EtoxiClear™: A New Adsorbent for the Efficient Removal of Endotoxin From Biopharmaceuticals

by Ben Galarza, Jason Shipp, Buzz Lobbezoo, Jennie Walden and Steve Burton

ProMetic BioSciences Ltd

About the poster:

Endotoxin or lipopolysaccharides (LPS) are highly toxic components of the cell wall of Gram-negative bacteria and are often present in significant amounts in bacterial cell culture 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.

This technical poster addresses the issues of removal of endotoxin from biological preparations. Specific reference will be made to a new synthetic ligand affinity adsorbent, EtoxiClear™, which exhibits high affinity for endotoxin, low protein binding and can be depyrogenated using sodium hydroxide. The bi-dentate ligand, attached to PBL’s proprietary base matrix – PuraBead®, binds in a spatially selective and optimal manner to the LPS molecule with a dynamic binding capacity for endotoxin in excess of 1,000,000 EU/mL of adsorbent (5 minute residence time). A number of biomolecules with different isoelectric points were used to demonstrate efficient recovery and clearance of residual endotoxin across the pH range. Protein recoveries in excess of 95% are achievable with endotoxin clearance to below 0.1 EU/mg protein.

Download the poster here.

If you'd like to join the Poster Hall at this year's BioProcess International, find out more at the webpage!

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