Demasking Endotoxin in Biopharmaceuticals for Reliable Endotoxin Test Results

Endo-RS® Endotoxin Recovery Kit (Surfactant)

Endo-RS® is a novel sample preparation method enabling complete endotoxin recovery in biopharmaceutical drug formulations typically containing non-ionic surfactants such as Polysorbate 20, Polysorbate 80 or Octylphenol ethoxylates. Non-ionic surfactants are well known to cause Low Endotoxin Recovery (LER). Intensive studies of the phenomenon have shown that the physicochemical properties of surfactants render endotoxin molecules inaccessible (masked) for detection in such samples. The Endo-RS® Endotoxin Recovery Kit provides the essential reagents and a detailed guideline for evaluating and establishing an optimized endotoxin demasking protocol for each individual formulation containing surfactants. Applying the Endo-RS® Endotoxin Recovery Kit prior to endotoxin detection with the EndoLISA® Endotoxin Detection Assay will ensure FDA-compliant and accurate results in spike validation studies and routine quality control testing.

Scientific publications on the mechanism causing LER and the biological activity of masked endotoxin (click on the links!):

All reagents needed for endotoxin demasking are included in the kit:

Endo-RS®, Item no. 609065

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Included: Buffer, Disturber, Adsorber, Modulator 1, Modulator 2, Reconfigurator, Endotoxin, Endotoxin-free Water.

Procedure for establishing a routine test protocol with Endo-RS®:

1. Screening
Selection of the agents suitable for the specific formulation

2. Optimization
Adjustment of protocol

3. Detection
Quantification of demasked (accessible) endotoxin with the EndoLISA® assay