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Real-Time Test for Detecting Microbial Contamination in Biopharmaceutical Applications

Millipore Corporation and Gen-Probe have launched the first product from their collaboration to create faster, sensitive, more robust tests for detecting contaminants in pharmaceutical and biotechnology manufacturing processes. The MilliPROBE system is the first solution of its kind for biopharmaceutical manufacturing. It combines Millipore's leading, industry-accepted sample prep methodologies with Gen-Probe's advanced, proven nucleic acid technologies to deliver both speed and sensitivity in one microbial screening tool.

The MilliPROBE system uses Real-Time Transcription-Mediated Amplification (TMA) technology to detect targeted microbial contamination within hours compared to the days or weeks usually required to generate results using traditional culture-based technology.

The collaboration's first MilliPROBE assay targets the bacterium Pseudomonas aeruginosa and is designed as an in-process, early warning system to provide faster, more effective detection of P. aeruginosa in purified water used during drug production.

The assay was designed to ensure a higher degree of water quality throughout manufacturing processes where the contaminant can be a serious quality and safety concern. The components of the MilliPROBE system are developed, manufactured and tested to work together to provide customers a complete solution that generates consistent, dependable results.

Building on the technological innovation of the initial MilliPROBE assay, Millipore and Gen-Probe intend to continue to develop new assays for additional contaminants over the next few years. These assays are expected to provide further significant improvements in speed, sensitivity, and specificity and incorporate future sample prep innovations that will allow real-time TMA technology to be applied to more challenging biopharmaceutical applications and target microorganisms.

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Source : Millipore Corp View Company Information

Posted on January 15, 2008