Endotoxin Detection Service - Low Endotoxin Recovery (LER)

Custom demasking protocol development and complete validation for biopharmaceutical formulations containing surfactants:

Endotoxin Hold Time Studies: In order to verify the reliability of the endotoxin assay, time-dependent endotoxin spiking studies with undiluted drug product lots are required by the FDA. The drug product lots are spiked with specified endotoxin levels, and held for several days (depending on matrix) before being assayed.

Demasking Protocol Development: Hyglos has unique expertise in the processes behind endotoxin masking and is specialized in developing and validating custom demasking protocols. The new methods Endo-RS® and EndoLISA® combined provide the technological basis for accurate determination of endotoxins in biopharmaceuticals containing surfactants (e.g. polysorbate). The Endo-RS® sample preparation can also be applied in combination with conventional BET test methods, such as LAL, which requires an optimization of the interface. As biopharmaceutical formulations differ in concentrations and compositions, for each formulation an optimized protocol is needed.

With extensive experience and strong customer orientation, Hyglos Custom Endotoxin Service is well positioned to supply the Pharma and Biotech industry with services customized to your quality control and regulatory needs. Contact us today to learn more!