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Revolutionize Your Endotoxin Testing

Embark on a journey that will challenge the traditional norms in endotoxin detection. Discover why rFC is the new standard, explore lab enhancements for streamlined efficiency, champion sustainability with the 3Rs, simplify data integrity through cutting-edge automation, and conquer complex samples in cell and gene therapy. 

Elevate your testing process today!

Revolutionize Your Endotoxin Testing

PART 1

Discover the Future of Endotoxin Detection with rFC and USP Chapter <86>

Endotoxin detection has long been reliant on the Limulus Amebocyte Lysate (LAL) method. The endotoxin detection landscape is evolving with the pending adoption of USP Chapter <86>. As LAL once eliminated the need for the rabbit test for the sake of scientific utility, recombinant Factor C (rFC) is becoming the new endotoxin test standard.

PART 2

Embrace rFC for Lab Transformation

Endotoxin detection is not just a regulatory requirement; it's a critical factor in ensuring pharmaceutical safety. It's time to discover the transformative power of Recombinant Factor C (rFC) and its journey from being an alternative assay to becoming a compendial method.

PART 3

Champion Sustainability: The 3R Revolution in Endotoxin Testing  

Recombinant Factor C (rFC) is a non-animal-derived reagent — since it is not harvested from wild animals as is LAL, the rFC assay helps alleviate pressures on its ecosystem derived from a growing demand for LAL. Additionally, because it is produced in an industrial lab, it is an inherently more reliable resource, ensuring greater supply chain security. 

PART 4

Data Integrity Management and Risk Mitigation Made Simple

The standards for proving data integrity have gotten stricter. Today, regulatory organizations from all over the world, such as the FDA, EMA, and PDMA, conduct audits more frequently, in a more extensive way, and observations are becoming more frequent. They demand that data is accurate and reliable. It’s in the best interest of pharmaceutical companies to design flexible and risk-based strategies to ensure data integrity.

PART 5

Solving the Endotoxin Detection Challenge for Difficult Samples

In the pharmaceutical industry, customers dealing with challenging products, particularly those in the cell and gene therapy sector, confront unique hurdles when it comes to ensuring product safety. This article explores the unique challenges faced by these customers in endotoxin testing and introduces our innovative solutions to address these challenges.

PART 6

Low Endotoxin Recovery (LER) and Biologic Drugs

Lets explore the critical importance of understanding endotoxin masking phenomenon and overcoming the Low Endotoxin Recovery (LER) challenges. In this article you’ll learn how innovative detection methods and protocols like Hold Time Studies (HTS) can help manufacturers enhance product safety and quality standards. 

eBook: Your Quick Guide To Better Endotoxin Testing

Unlock our comprehensive eBook that will guide you through endotoxin best practices, with valuable insight into support, development, and performance of Limulus-based testing.