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Comprehensive Endotoxin Services with a special expertise in Low Endotoxin Recovery (LER) including hold-time studies, test protocol development and validation.
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Routine Endotoxin Testing & Feasibility Studies:
We offer routine endotoxin testing as well as feasibillity and comparison studies using rFC and conventional methods.
Our method validation services include all of the validation steps required during a product validation and requested by regulatory authorities.
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 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.
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:
We are 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, validation, training and support.
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