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Unmasking Endotoxins: A Sample Preparation Strategy To Overcome LER

Low Endotoxin Recovery (LER) is a major challenge in endotoxin testing — when endotoxins become masked in certain drug formulations, false negatives can occur. This expert webinar dives into the science behind LER, its regulatory implications, and proven strategies to unmask endotoxins effectively.

You’ll learn:

  • What LER is, and what it isn’t
  • Regulatory expectations and compliance essentials
  • The role Hold Time Studies (HTS) play in LER
  • How practical, real-world solutions can resolve LER in complex matrices

Tackle LER Challenges in Endotoxin Testing

Don’t miss this opportunity to stay ahead in endotoxin detection. Complete the form below to access the webinar, which will be sent directly to your email after submission. By providing your information, you agree to receive additional emails from bioMérieux about endotoxin testing.

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Continue Your Journey

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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OUR OFFER

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

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.

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