Millipore and Roka Bioscience to Develop Real-Time Molecular Tests for Biopharmaceutical Applications

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By Millipore Friday, October 16, 2024

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Creation of Roka Bioscience will accelerate development of new assays and portable instruments

BILLERICA, Mass. – September 14, 2024 – Millipore Corporation (NYSE:MIL), a leading provider of technologies, tools and services for the global life science industry, today announced that it will collaborate with Roka Bioscience, Inc. to develop molecular assays and portable instruments for biopharmaceutical production. As recently announced by Gen-Probe Incorporated (NASDAQ: GPRO), Roka Bioscience is a new, independent company created through the spin-off of Gen-Probe’s industrial assets.

Millipore and Gen-Probe formed an exclusive partnership in 2005 to develop faster, more reliable and sensitive tests for contaminants commonly found in pharmaceutical and biotechnology manufacturing processes. Last year, they introduced the MilliPROBE® system, which is the first solution of its kind and 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 companies currently have one assay on the market for Pseudomonas aeruginosa and are developing a second assay for Mycoplasma that remains on track to be introduced early next year.

The revolutionary MilliPROBE system uses Real-Time Transcription-Mediated Amplification (TMA) technology to detect targeted microbial contamination within four hours compared to days or weeks required to generate results using traditional culture-based technology. Faster detection allows biopharmaceutical manufacturers to take corrective action earlier in their production process, which limits the impact of a contamination event, reduces downstream processing risks, optimizes product yields, and improves final product quality. These improvements enable operational efficiency and lower manufacturing cost for biopharmaceutical manufacturers.

“We believe that the creation of Roka Bioscience will help us to accelerate the development of further MilliPROBE assays due to the focus and investment they will bring to the partnership,” said Jean-Paul Mangeolle, President of Millipore’s Bioprocess Division. “Roka Bioscience’s investment into a fully integrated, portable testing instrument will also bring us closer to our vision of providing rapid tests that can be conducted right on the manufacturing floor. We remain very excited about the market potential for the MilliPROBE platform and about the major milestone that the launch of our Mycoplasma assay will represent for our partnership.”

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