Revolutionize Your Endotoxin Testing

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.

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.

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. 

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.

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.

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.