Resolving an Analytical Issue – Demasking of Endotoxin with Endo-RS® – hyglos

Leading manufacturers of biopharmaceuticals have determined that endotoxin (LPS) can be masked in biopharmaceutical formulations typically containing phosphate, polysorbate, and sugars. In a masked state, endotoxin is undetectable by the commonly used factor C detection methods such as the Limulus amebocyte lysate test (LAL). This phenomenon has also been denominated Low Endotoxin Recovery (LER). The German biotech company Hyglos is leading a dedicated research effort to develop an endotoxin demasking protocol for affected biopharmaceutical formulations. The project has now resulted in a sample preparation method enabling complete recovery of endotoxin out of affected formulations. The new method called Endo-RS® Endotoxin Recovery Kit comprises the following four steps: disturbing hydrogen bonding, adsorption of surfactants, displacement of the endotoxin and formation of endotoxin aggregates required for detection. The reagents in the kit provide a toolbox for demasking endotoxins. Due to differences in buffer compositions of masked samples, the amounts and concentrations of the required demasking reagents must be adapted for each individual formulation in order to optimize the endotoxin recovery. Endo-RS® is intended for sample preparation of biopharmaceutical drug formulations with subsequent endotoxin detection using the EndoLISA® Endotoxin Detection Assay. www.hyglos.com

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