Lonza introduces next generation endotoxin detection software
Complete enterprise system offers remote real-time viewing and approving of endotoxin detection results from a networked database
Lonza Group, the global life sciences company, offers 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 more than 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 minimise key strokes, reducing data entry time and improving template creation efficiency.
WinKQCL® 4 supports current and new customers globally with multilingual 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.
‘We are proud to offer this comprehensive solution to customers of all sizes worldwide,’ said Doug Danne, head of Lonza’s Rapid Testing Systems business. Version 4’s analytical tools and user interfaces provide truly meaningful advancements in endotoxin detection.’
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 commercialise a quantitative LAL method.
In 1981, the QCL-1000® 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 PYROGENT® 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 revolutionised 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.
