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ENDO-RS® enables full quantitative recovery of endotoxin in biopharmaceutical samples affected by Low Endotoxin Recovery (LER) independent of storage time and endotoxin concentration.
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In several scientific studies it has been demonstrated that biologics typically containing protein in high concentrations and non-ionic surfactants such as polysorbate in combination with chelating agents are likely to change the aggregate state of the analyte endotoxin in such a way that it is no longer accessible for detection with Factor C-based endotoxin tests such as Limulus Amebocyte Lysate (LAL) and Recombinant Factor C (rFC).
Selected scientific publications on LER and the biological activity of masked endotoxin:
• Masking of endotoxin in surfactant samples: Effects on Limulus-based detection systems - Reich et al, Biologicals, 2016
• Biological Activity of Masked Endotoxin - Schwarz et al, Nature, 2017
• Low Endotoxin Recovery, A Brief Overview - Wintzingerode (Roche), American Pharmaceutical Review, 2016
The ENDO-RS® method developed by Hyglos - a bioMérieux company, is a unique toolbox for sample preparation addressing masking of endotoxin at the root cause. The method enables complete endotoxin recovery in biopharmaceutical drug formulations affected by Low Endotoxin Recovery (LER). All needed reagents are included in the kit for developing a formulation-specific sample preparation protocol in combination with the EndoLISA® assay. It is possible to apply ENDO-RS® in combination with conventional LAL, but not directly without interface optimization.
Contact our ENDOXPERTSTM Services to find out how we develop a protocol according to regulatory requirements.
Endotoxin Recovery Kit (Surfactant)
A toolbox for demasking endotoxin in pharmaceutical formulations exhibiting Low Endotoxin Recovery (LER)
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