contractpharmaApril 13, 2021
Tag: Lonza , PyroTec PRO , endotoxin testing
Lonza has expanded its 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 third test type option allows 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 on the original 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 WinKQCL Endotoxin Analysis Software, this complete 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 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 increasing focus 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, according to the company.
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