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Low Endotoxin Recovery: A Mitigation Approach Case Study

This white paper discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference. Authors Dr Christian Faderl and Kevin L. Williams detail the steps for conducting a demasking study and walk through the process, providing a comprehensive case study.

"Once a development scheme has been achieved, the user can test this using different lots of materials (drug and test kits and reagents) and, if desired, using different analysts. Such a test, once developed, with validation performed and documented, should be no more difficult to perform routinely than any other QC bacterial endotoxin test (BET)," the authors state.

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Tackle LER Challenges in Endotoxin Testing

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Unmasking Endotoxins: A Sample Preparation Strategy To Overcome LER

This expert webinar dives into the science behind LER, its regulatory implications, and proven strategies to unmask endotoxins effectively.

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ENDOXPERTS™ Services

ENDOXPERTS™ Endotoxin Services by bioMérieux provide routine testing and feasibility studies as well as specialized services for analytical issues such as LER. Our work for leading pharmaceutical companies has resulted in validated methods for LER, fulfilling regulatory requirements. 

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WHITE PAPER

Low Endotoxin Recovery: A Comprehensive Overview for Biologic Drug Manufacturers

Endotoxin detection is an integral part of the quality control process, and LER muddles the reliability of results, which can result in risks to patient safety and noncompliance with regulations. 

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WHITE PAPER

The Hunt for the Missing Endotoxin

This white paper explores the causes and impact of low endotoxin recovery (LER) and presents solutions, including guidance on in-house protocol development, outsourcing considerations, and the use of the ENDO-RS® de-masking tool kit. It also features expert insights from Dr. Christian Faderl on how pharmaceutical manufacturers can effectively address masked endotoxins.

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