Endotoxin Detection Services - including Low Endotoxin Recovery (LER)

Hyglos offers full Endotoxin Services with a special focus on samples affected by Low Endotoxin Recovery (LER) including hold-time studies, test protocol development and GMP-compliant validation.

With extensive experience and a strong and flexible customer orientation, Hyglos Endotoxin Services are well positioned to supply the Pharma and Biotech industry with services customized to your quality control and regulatory needs. Contact us for more information.

Method Validation & Feasibility Studies: Our method validation service includes all of the validation steps required during a product validation and requested by regulatory authorities. We also offer feasibillity and comparison studies using different methods of your choice available on the market (including rFC and conventional LAL).

Endotoxin Hold-Time Studies: In order to verify the reliability of the used endotoxin assay, we conduct and report time-dependent endotoxin spiking studies with undiluted drug product lots according to the regulatory requirements. The drug product lots are spiked with specified endotoxin levels and held for several days, depending on sample, before being assayed. A decline in endotoxin concentration over time is indicative of LER. The following are selected publications on the mechanism causing LER and the biological activity of masked endotoxin [click on the links!]:

Root-cause analysis of LER: In case of a drug product being affected by LER, a thorough investigation of the underlying causes of the phenomenon in the specific drug product is conducted, as well as for sample containers, API formulation and individual excipients.

Demasking Protocol Development: Hyglos 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. Our demasking service includes method transfer, training and support.