ENDOZYME^® II GO

This white paper reviews the causes contributing to low endotoxin recovery (LER), the impact it creates, as well as solutions which can rectify the issues it results in. We also discuss the advantages and disadvantages of developing your de-masking protocols in-house, and how you can use the ENDO-RS® de-masking tool kit to make the process easier from beginning to end. Following this, we outline the pros and cons of outsourcing your de-masking project, what you should look for in a third-party company, and why you can and should trust bioMérieux with your de-masking protocol development.

Both pharmaceutical companies and regulators have the same goal — ensuring continuous supply of safe drugs and therapies. Global pharmaceutical companies depend upon robust global supply chains to fulfil their endotoxin testing requirements to ensure patient safety. rFC is a safe, sustainable endotoxin testing solution that could mitigate many of the adverse trends impacting global supply chain consistency.

This case study 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.

From traditional to alternate endotoxin testing methods used for product release testing, there is an opportunity to waste less reagent and generate cost savings. Given that Limulus Amoebocyte Lysate (LAL) is packaged in vials (2.6 or 5.2mL) and reconstituted as needed, there is inevitable waste compared to using recombinant Factor C (rFC).