12 Apr 2021
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- The PyroTec® PRO Automated Solution combined with the PyroWave® Reader option expands the range of endotoxin testing types available on the platform to now include the PyroGene® Recombinant Factor C assay
- The addition of the PyroWave® XM Fluorescent Reader complements the existing absorbance readers used in traditional LAL-based assays
- Full integration with the WinKQCL® Endotoxin detection and analysis software enables automated testing that meets data integrity requirements
Quote from Orla Cloak, Director of Testing and Informatics Solutions, Lonza BioScience:
“This new addition to our established PyroTec® PRO Solution provides laboratories with greater ability to reduce errors and increase throughput while retaining their trusted endotoxin method. Customers can utilize the best method for their specific sample requirements while also furthering their efforts to more fully automate the QC lab and increase utilization of sustainable solutions.”
Basel, Switzerland, 12 April 2021 – Lonza has announced an expansion to its popular PyroTec® PRO Automated Robotic Solution for endotoxin testing. The new PyroWave® Reader add-on has been designed specifically for use with the sustainable PyroGene® Recombinant Factor C (rFC) Assay. This brings a third test type option to the platform, allowing QC microbiologists to choose the endotoxin test method best suited for their testing needs. The PyroTec®PRO Solution, now compatible with Lonza’s PYROGENT®-5000 Turbidimetric LAL (Limulus Amebocyte Lysate) Assay, Kinetic-QCL® Chromogenic LAL Assay and the PyroGene® rFC Assay, expands the options available for streamlined, automated endotoxin testing.
The PyroWave® Reader add-on is built upon the original release of the PyroTec® PRO Automated System that includes two absorbance readers for traditional LAL-based assays. Able to easily accommodate different assay types in the same run and powered by the world-class WinKQCL® Endotoxin Analysis Software, this complete system further increases the efficiencies and data integrity gained from automated endotoxin testing.
The PyroGene® rFC Assay is an animal-free method for endotoxin detection that works through a single enzymatic step. It has been shown to be equivalent to other photometric endotoxin methods that use LAL to detect endotoxins according to the parameters listed in the USP chapter <1225> “Validation of Compendial Procedures”. These parameters include linearity, specificity, precision, accuracy, and limit of detection.
The need for accurate and dependable endotoxin testing technology continues to grow, especially with the pharmaceutical industry increasingly focusing on the development of innovative biotherapeutics that carry a higher risk of endotoxin contamination. Through process optimization and automation of routine manual tasks, the PyroTec®PRO Automated Robotic Solution enables users to streamline and improve the performance of the QC laboratory, increasing lab efficiency and productivity. Automated endotoxin testing can also substantially reduce the potential for human error, enhancing the accuracy, reliability, and traceability of results.
For more information about the PyroTec® PRO Automated System, visit www.lonza.com/endotoxin-automation.