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Millipore Launches the New MilliPROBE® Detection System for Mycoplasma

Millipore Corporation
290 Concord Road
Billerica, Massachusetts 01821
phone: +1 978-715-4321

Millipore Corporation, a leading provider of technologies, tools and services for the global life science industry, announced the launch of a new product from its ground-breaking collaboration with Roka Bioscience to develop faster, more robust tests for contaminants in pharmaceutical and biotechnology manufacturing. The MilliPROBE® Detection System for Mycoplasma is the first solution of its kind for the early detection of Mycoplasma contamination in the highly regulated biopharmaceutical manufacturing industry.

"The launch of our new MilliPROBE System represents a breakthrough innovation and is the culmination of four years of collaborative work to change the way the industry tests for Mycoplasma," said Jean-Paul Mangeolle, President of Millipore's Bioprocess Division. "The system builds on Millipore’s strength in mycoplasma risk management. It integrates our industry-leading sample preparation technologies and testing expertise with core molecular diagnostics technologies developed by Gen-Probe, Incorporated (and recently licensed to Roka Bioscience), to deliver a unique solution that addresses an immediate and critical market need. We are extremely excited about the market opportunity for the MilliPROBE System."

Mycoplasma is a small, slow-growing and self-replicating bacteria that is extremely difficult to detect and eliminate from biopharmaceutical manufacturing processes. Mycoplasma contamination can have costly consequences for biopharmaceutical manufacturers, who must often destroy an entire drug batch and shut down production facilities for an extended period when Mycoplasma contamination is detected.

The MilliPROBE Detection System for Mycoplasma, the newest assay in Millipore’s MilliPROBE platform aimed at rapid microbial detection, cuts detection time from between 28 and 35 days (for traditional culture-based technology) to just four hours. Faster and more robust detection enables biopharmaceutical manufacturers to test more frequently and take corrective action earlier in the production process, reducing financial risks and optimizing product yields.

"The MilliPROBE system is unique because it can be operated by technicians with limited molecular training, while meeting the stringent requirements of the biopharmaceutical quality control lab," noted Roland Heinrich, Millipore Vice President, Process Monitoring. "It includes a novel Millipore sample preparation device designed to handle complex bioreactor samples in larger volumes than other mycoplasma testing products. It also includes Gen-Probe’s new Background Reduction Technology (the first of its kind), which protects the assay from contamination that can cause false positive results - a prevalent testing problem representing substantial financial risk for customers."

"We will continue to leverage our ongoing partnership with Roka Biosciences to introduce additional MilliPROBE assays in the future," Heinrich added.

In 2005, Millipore and Gen-Probe, based in San Diego, California, formed an exclusive partnership to develop faster, more reliable and sensitive tests for contaminants commonly found in pharmaceutical and biotechnology manufacturing processes. In September, 2009, Millipore transferred its collaboration to Roka Bioscience, an independent company created through the spin-off of Gen-Probe’s industrial assets.

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