EndoTrap® HD Removed Endotoxin from Emergency Use Phage Cocktail for UTI Treatment
EndoTrap® HD endotoxin removal products were cited in a Baylor College of Medicine and University of California San Diego study by Austen Terwilliger et al., “Phage Therapy Related Microbial Succession Associated with Successful Clinical Outcome for a Recurrent Urinary Tract Infection.”
The Food and Drug Administration (FDA) granted approval for the emergency use of a phage cocktail for the study participant, a 56-year-old male liver transplant with recurrent prostate and urinary tract infections caused by an extended-spectrum beta-lactamase (ESBL)-producing E. coli strain.
EndoTrap® HD column, manufactured by Lionex GmbH, was used to remove endotoxin from a phage cocktail with the following concentration: HP3–7.5 × 109 plaque forming units (PFU)/mL (Accession KY608967); HP3.1–1.35 × 1010 PFU/mL (Accession OK275722); ES17–1.37 × 1010 PFU/mL (Accession MN508615); ES19–3.35 × 109 PFU/mL (Accession MN508616).
The final concentration of endotoxin units delivered per 109 PFU was 22.83 EU/dose, which was well within the 5 EU/kg/hr limit appropriate for the patient (weight 68.6 Kg).
The study goes on to describe the successful resolution of the complicated and recurrent infection following a combined treatment with the phage cocktail and ertapenem.
This content has been adapted from the paper below. You can find the entire paper via the link:
Terwilliger, Austen et al. “Phage Therapy Related Microbial Succession Associated with Successful Clinical Outcome for a Recurrent Urinary Tract Infection.” Viruses vol. 13,10 2049. 12 Oct. 2021, doi:10.3390/v13102049
EndoTrap® HD is an affinity chromatography resin based on a bacteriophage-derived protein which binds to endotoxins with high affinity and specificity. It removes endotoxins (lipopolysaccharides/LPS) from aqueous solutions of a wide range of samples such as proteins, antibodies, vaccines, nucleic acids, buffers and cell extracts with excellent sample recovery rate.
EndoTrap® HD is especially useful in the removal of endotoxin from phage preparations. A study by Ville Hietala et al., "The Removal of Endo- and Enterotoxins From Bacteriophage Preparations", compared different purification methods to determine the ideal method to remove endotoxin from phage.
The methods evaluated included precipitation with polyethylene glycol, ultracentrifugation, ultrafiltration, anion exchange chromatography, octanol extraction, two different endotoxin removal columns, and different combinations thereof.
The study concluded that "EndoTrap HD column was the optimal way to remove endotoxins from phage preparations. The use of the column needed only little hands-on-time and resulted in extremely low endotoxin-to-phage ratio with high phage recovery. In addition, the scale-up is straightforward. The purification of E. coli phage produced lower endotoxin concentration than that of the A. pittii phage, but even the fHyAci03 product was pure enough for parenteral administration. To our surprise, the Pierce endotoxin removal column behaved very differently: Even though the phage recoveries were good, there was only minimal improvement in the endotoxin-to-phage ratio."
Ilex Life Sciences LLC is an official distributor of LIONEX GmbH products. To learn more about EndoTrap® HD, please visit our EndoTrap® HD product page.