Millipore And Gen-Probe Launch First Real-Time Test For Detecting Microbial Contamination In Biopharmaceutical Applications

Main Category: Pharma Industry / Biotech Industry
Also Included In: Pharmacy / Pharmacist
Article Date: 10 Jan 2008 - 2:00 PDT

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Millipore Corporation (NYSE:MIL) and Gen-Probe (NASDAQ:GPRO) announced the launch of the first product from their ground-breaking 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. Faster detection allows biopharmaceutical manufacturers to take corrective action earlier in the production process, which reduces downstream processing risks, optimizes product yields, and improves final product quality. These improvements may result in better operational efficiency and lower manufacturing cost for product manufacturers.

"The launch of our first MilliPROBE product represents a significant scientific breakthrough and demonstrates the promise new technologies offer for quick and accurate detection of microbial contaminants in biopharmaceutical processes," said Martin Madaus, Chairman & CEO of Millipore. "For the first time, Millipore's biotechnology and pharmaceutical customers have a viable alternative to culture-based tests that can take several days to generate results. We are excited about the progress we have made in our collaboration with Gen-Probe and we look forward to developing additional assays using the MilliPROBE system over the next few years."

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 Pseudomonas 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.

"We are pleased with the initial results of this collaborative effort between Millipore and Gen-Probe," said Hank Nordhoff, Chairman, President and CEO of Gen-Probe. "Scientists from both companies are breaking new ground in combining best-in-class technologies to meet the needs of pharmaceutical and biopharmaceutical manufacturers. We believe there is a bright future for this new generation of rapid, real-time TMA-based screening tools."

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.

About Millipore

Millipore (NYSE: MIL) is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, we collaborate with customers to confront the world's challenging human health issues. From research to development to production, our scientific expertise and innovative solutions help customers tackle their most complex problems and achieve their goals. Millipore Corporation is an S&P 500 company with more than 6,100 employees in 47 countries worldwide. For more information, visit the Millipore website at http://www.millipore.com.

About Gen-Probe

Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has approximately 25 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,000 people. For more information, go to http://www.gen-probe.com.

Forward Looking Statements

Millipore

The matters discussed herein, as well as in future oral and written statements by management of Millipore Corporation that are forward-looking statements, are based on current management expectations that involve substantial risks and uncertainties which could cause actual results to differ materially from the results expressed in, or implied by, these forward-looking statements.

Potential risks and uncertainties that could affect Millipore's future operating results include, without limitation, the inability to successfully integrate Serologicals or other acquired businesses; failure to achieve design wins into our pharmaceutical and biotechnology customers' manufacturing design phase for a particular drug; delay, suspension or termination of a customer's volume production; lack of availability of raw materials or component products on a timely basis; regulatory delay in the approval of new therapeutics; limitations on cash flow available for operations and investment due to increased debt service obligations; the inability to establish and maintain necessary product and process quality levels; reduced demand for cell culture products using bovine serum; the inability to realize the expected benefits of development, marketing, licensing and other alliances; competitive factors such as new membrane or chromatography technology; the inability to achieve anticipated cost benefits of our supply chain initiative; risks relating to our concentration of principal manufacturing operations; the inability to utilize technology in current or planned products due to overriding rights by third parties; potential environmental liabilities; conditions in the economy in general and in the bioscience and bioprocess markets in particular; foreign exchange fluctuations; reduced private and government research funding; exposure to product liability claims; and difficulties inherent in transferring or outsourcing of manufacturing operations. Please refer to our filings with the SEC, including our most recent Annual Report on Form 10-K, for more information on these and other risks that could cause actual results to differ.

Gen-Probe

Any statements in this press release about Gen-Probe's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, may, anticipate, estimate, intend, plan and would. For example, statements concerning customer adoption, the performance of future assays, and plans and objectives of management are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied.

Some of these risks, uncertainties and assumptions include but are not limited to: (i) the market for the sale of our new industrial products may not develop as expected, (ii) the development of new industrial products may not proceed as planned, (iii) we may not be able to compete effectively, (iv) we may not be able to maintain our current corporate collaborations, (v) we are dependent on Millipore for the distribution of some of our products, and (vi) our intellectual property may be infringed by third parties or invalidated. The foregoing list sets forth some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we file with the SEC, including our most recent annual report on Form 10-K and all subsequent periodic reports. We assume no obligation and expressly disclaim any duty to update forward-looking statements to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.

http://www.millipore.com
http://www.gen-probe.com