Lonza expands endotoxin testing solution

Published: 13-Apr-2021

The PyroWave Reader add-on has been designed specifically for use with the sustainable PyroGene Recombinant Factor C (rFC) Assay

Lonza has announced an expansion to its PyroTec PRO Automated Robotic Solution for endotoxin testing. The 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 accommodate different assay types in the same run and powered by the WinKQCL Endotoxin Analysis Software, the system is designed to further increase 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’s reportedly 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 focusing on the development of biotherapeutics carrying a higher risk of endotoxin contamination. The PyroTec PRO Automated Robotic Solution is aimed to enable 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, the company says.

Orla Cloak, Director of Testing and Informatics Solutions, Lonza BioScience said: "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."

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