Lonza Introduces Next Generation Endotoxin Detection Software

April 01,2009 Basel, Switzerland

Lonza Group Ltd., the global life sciences company, announces the next generation in software to collect and report quantitative Endotoxin test results. This software has been exclusively developed by Lonza for Endotoxin detection systems globally for over 20 years.

WinKQCL® 4 software is the evolution of Lonza’s industry leading endotoxin detection and analysis software, providing a fully-integrated quantitative solution for testing, data management and reporting. Dynamic trending functionality allows comparative assessment of process, product, and analyst performance over time. WinKQCL® 4 provides valuable information supporting quality and process control decisions. And intelligent user interfaces provide easy-to-use “drag-n-drop” and SpeedFill™ features that minimize key strokes, reducing data entry time and improving template creation efficiency. WinKQCL® 4 supports current and new customers globally with multi-lingual interfaces in English, French, German, Italian, Japanese, and Spanish.

The WinKQCL® 4 software automatically searches for available readers and communicates with robotic control systems. WinKQCL® 4 software meets the FDA 21 CFR Part 11 requirements for electronic records and signatures. It is a complete enterprise system that offers remote real-time viewing and approving of endotoxin detection results from a networked database. Doug Danne, Head of Lonza’s Rapid Testing Systems business summarized by saying, “We are proud to offer this comprehensive solution to customers of all sizes worldwide. Version 4’s analytical tools and user interfaces provide truly meaningful advancements in endotoxin detection”.

About Lonza Rapid Testing Systems

Lonza Rapid Testing Systems in Walkersville, Maryland has been providing endotoxin detection products and services since the 1970s beginning with the gel clot LAL assay. Lonza was the first manufacturer to develop and commercialize a quantitative LAL method. In 1981, the QCL-1000â endpoint chromogenic LAL assay gave the LAL-user the ability to quantify the amount of endotoxin in its test sample. With the acquisition of the PYROGENTâ gel clot LAL in 1986, Lonza strengthened its gel clot products offering. Lonza scientists continued to develop an easier and more sensitive quantitative method and in 1989, launched Kinetic-QCL, the kinetic chromogenic LAL method that revolutionized Endotoxin detection testing.

With the Kinetic-QCL method, came the first generation of dedicated endotoxin detection software. In the 20 years since the first endotoxin test was run with the software onboard the Kinetic-QCL plate reader, test methods and the software have seen significant advances. In 2002, Lonza brought to market an endotoxin detection method that does not rely on the horseshoe crab as the source of the raw material. Lonza’s PyroGene® assay uses a recombinant form of the horseshoe crab’s endotoxin-sensitive Factor C. The PyroGene assay offers exceptional performance and improved lot-to-lot consistency versus biologically based products while reducing dependency on the horseshoe crab. As the assay methods have continued to evolve over the years, so has endotoxin detection software from Lonza.


About Lonza

Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets.

Lonza is headquartered in Basel, Switzerland and is listed on the SIX-Swiss Exchange. In 2008, Lonza had sales of CHF 2.937 billion. Further information can be found at www.lonza.com.


For further Information:

Lonza Rapid Testing Systems Sr. Product Manager
Name Maribeth Janke, Ph.D
Tel 301.898.7025 x2323
Fax 301.845.4024
Email maribeth.janke@lonza.com

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