The safety of injectable medicinal drugs is critically dependent on reliable quality control ensuring the absence of pyrogens, predominantly endotoxins, throughout drug development and routine manufacturing. For the last few decades, endotoxin testing has evolved to reach today’s optimized test systems that include robust reagents, traceable reference standards, data integrity compliant software, and qualified instrumentation.

However, traditional endotoxin tests still rely on a natural resource, the Limulus amebocyte lysate (LAL) prepared from the blue blood of the horseshoe crab. While conservation efforts have led to stable populations in North America, other populations are under pressure. Robust industry growth and global harmonization of pharmaceutical production sites have increased the interest and demand for sustainable pyrogen and endotoxin testing reagents and automated systems that provide reliable results throughout the drug development process.

Based on decades of experience in pyrogen testing, Lonza provides a portfolio of testing solutions to meet your current endotoxin and pyrogen testing needs, while providing qualified options to sustain your future growth:

• Traditional and sustainable test systems – Gel clot, turbidimetric and chromogenic LAL and recombinant factor C  assays in a variety of sizes and sensitivities meet all of your testing requirements
• Regulatory compliance – World-class WinKQCL® Endotoxin Detection and Analysis Software ensures data compliance from stand-alone instruments to large network communications
• Automation – Reduce errors and repetitive manual steps with the PyroTec® Pro Automated Solution for endotoxin testing

The next chapter in endotoxin testing. . . Let's write it together.

Visit: bioscience.lonza.com/endotoxin-testing