The FDA’s Pyrogen and Endotoxin Testing Q&A Guidance

  • Leading innovation for endotoxin detection products, services and software

  • Gain from our practical knowledge and endotoxin expertise

  • WinKQCL™ software platform has supported the pharmaceutical industry worldwide for over 20 years

Listen to Allen Burgenson, Lonza's Regulatory Affairs Manager,

review the FDA’s latest guidance on Pyrogen and Endotoxin Testing


Duration: 27:22


Endotoxin Detection is a part of Lonza BioScience’s QC Testing and Analytical Services that offers a comprehensive QC platform.

Endotoxin Detection Expertise 

Lonza has been providing endotoxin detection products and services for nearly 40 years, leading the way in innovation for products, methods and software.In the 1980s, Lonza developed and commercialized the first FDA licensed endpoint quantitative Limulus Amebocyte Lysate (LAL) assay, QCL-1000™ Endpoint Chromogenic LAL Assay. We continued to improve upon the quantitative technologies by launching the Kinetic-QCL™ LAL Assay, the kinetic chromogenic LAL method that revolutionized endotoxin detection testing.In 2003, Lonza brought to market an endotoxin detection method that does not rely on the use of horseshoe crab blood as the raw material. The PyroGene™ assay uses a recombinant form of Factor C (rFC), the endotoxin-sensitive protein that initiates the LAL clotting cascade.   The recombinant technology is endotoxin-specific, eliminating false-positive glucan reactions. It offers exceptional performance and reliable, lot-to-lot consistency, compared to biologically based products, while reducing the dependency on the horseshoe crab.  In 2009, 510(K) submissions were FDA-approved using PyroGene™ rFC as a final release test. 


Welcome to the Evolution 
Recognizing the importance that software plays in accurate analysis and reporting, Lonza has made significant investments in software and has its own in-house development systems and programmers, dedicated to producing robust endotoxin detection software.

WinKQCL™ Software is Lonza’s industry leading endotoxin detection and analysis software offering a fully-integrated solution for quantitative endotoxin detection testing, data management and reporting needs. WinKQCL™ Software meets 21 CFR Part 11 technical requirements for electronic records and signatures, audit trails and database archiving.


Endotoxin Testing Services 
Our Endotoxin Testing Services (U.S. and Europe) are designed for customers from the pharmaceutical industry, medical device companies, research and environmental laboratories.

Our laboratories in Walkersville, Maryland and Verviers, Belgium, are located in cGMP-certified manufacturing plants, providing a high level of expertise in methods for endotoxin testing.


USP and EP Compliant 
Pharmaceutical-grade testing includes all of the validation steps required during a product validation program and requested by regulatory authorities to be compliant with the current harmonized Bacterial Endotoxins Test (BET) as defined in the U.S. Pharmacopeia (USP) and European Pharmacopeia (EP). For the medical device industry, our service complies with the USP Monograph General Chapter, Citation <161> Transfusion and Infusion Assemblies and Similar Medical Devices.


As a primary manufacturer of LAL, we offer a wide range of endotoxin testing solutions to fit your requirements.  From the simplicity of gel clot testing to the productivity of fully robotic systems, Lonza covers the LAL evolutionary scale. 


Global Endotoxin Testing Summit

In 2015, Lonza introduced its first Global Endotoxin Testing Summit to create a casual forum for users, vendors and regulators to come together and discuss hot topics within the endotoxin testing industry. Based on actual user feedback, the summit covers a range of topics from endotoxin testing basics and regulatory updates to current hot-button topics like Low Endotoxin Recovery.

The Global Endotoxin Testing Summit is a unique forum where attendees not only come together to discuss topics significant to the endotoxin detection industry, but also gain hands-on insight into the biology ecological role of the animal so precious to our work – the horseshoe crab.  In collaboration with the Ecological Research and Development Group (ERDG)  and their Just Flip ‘em!® program, attendees of the Lonza summit will have the opportunity to visit a Horseshoe Crab Sanctuary Beach during the peak of spawning season to save and “flip” crabs that have been stranded on shore. 

The Global Endotoxin Testing Summit is where innovative and exciting ideas are shared amongst those who play a critical role in shaping how we execute endotoxin testing in QC labs on a daily basis. Visit the Global Endotoxin Testing Summit home page for more details about the next event.