About Lonza : Lonza is one of the world's most trusted suppliers to the pharmaceutical, biotech and specialty market. We harness science and technology to create products that support safer and healthier living and enhance quality of life.
Lonza is a leading expert and provider of high quality endotoxin detection products for nearly 40 years. Starting in the early 80s with the development of the first FDA licensed quantitative endpoint Limulus Amebocyte Lysate (LAL) assay, Lonza was constantly working on the improvement of the quantitative technologies and launched the Kinetic-QCL ™ LAL Assay, a kinetic chromogenic LAL method that revolutionized endotoxin detection testing.
In 2003 Lonza brought to the market an endotoxin detection method that does not rely on the use of horseshoe crab blood as raw materials. 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 high batch-to-batch consistency, compared to classical biologically based methods, while reducing the dependence on the horseshoe crab. In 2009, 510 (K) submissions were FDA-approved using PyroGene ™ rFC as a final release test.
Recognizing the importance of software in accurate analysis and reporting, Lonza has developed its own endotoxin detection software.WinKQCL ™ Softwareis offering a fully-integrated solution for managing, reporting and analyzing endotoxin assay results. It is the ideal tool to accompany your quantitative endotoxin detection. WinKQCL ™ Software is industry leading and meets 21 CFR Part 11 technical requirements for electronic records and signatures, audit trails and database archiving.
To further support your data-integrity Lonza developed a comprehensive informatics platform that automates quality control (QC) processes for all regulated manufacturing. The MODA ™ Solution encompasses automation of the full spectrum of QC activities including environmental monitoring (EM), utility testing, and product testing.