ENDOZYME^® II GO

Most new users of Limulus-based tests want to review basic knowledge around endotoxin and endotoxin detection, while more experienced users want to review the practical aspects of testing with an eye toward meeting ever-changing regulatory expectations. They also want to generate laboratory dialog as to how to apply basic principles and “best practices” to increasingly complex tasks including method development, verification, validation and the routine testing of various drug types. This material can also serve as a supplement to a user’s basic endotoxin training.

With industry’s push to build a more diverse global supply chain, we find ourselves at a tipping point for the widespread adoption of alternative solutions like rFC — driven as much by industry, if not more, than regulators.

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.

Professor Jeak Ling Ding is a world-renowned pioneer in the field of molecular biotechnology. We spoke with Professor Ding to learn more about her career defining breakthrough to genetically engineer recombinant Factor C, and the importance of creating a sustainable and ethical alternative to replace traditional methods of endotoxin testing. 

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.