|Lonza Verviers SPRL
Industrial Park Petit-Rechain, 4800 Verviers - BELGIUM
+33 8732 1611
About Lonza : Lonza is one of the world's leading and Most Trusted suppliers to the pharmaceutical, biotech and specialty ingredients market. We harness science and technology to create products That medium safer and Healthier living and That Enhance the overall quality of life.
Lonza is a leading expert and provider of high quality products for endotoxin detection 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 lancé first the Kinetic-QCL ™ LAL Assay, a kinetic chromogenic LAL method That Revolutionized endotoxin detection testing.
In 2003 brought` Lonza to the market year endotoxin detection method That Does not Rely on the use of horseshoe crab blood as the raw material. The pyrogenic ™ 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 reactions glucan. It offers exceptional performance and high batch-to-batch consistency, Compared to classical biologically based methods, while Reducing the dependency on the horseshoe crab. In 2009, 510 (K) submissions Were FDA-approved using pyrogenic ™ rFC as a final test release.
Recognizing the importance That software plays in accurate analysis and reporting, HAS Developed Lonza icts own endotoxin detection software.WinKQCL ™ SoftwareOffering is 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 CFR Part 21 11 technical requirements for electronic records and signatures, audit trails and archiving database.
To further Top supporting your data-integrity needs Lonza Developed a comprehensive informatics platform That controllers 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.