Millipore and Roka Bioscience to Develop Molecular Tests for Biopharmaceutical Manufacturing

Millipore is partnering with Roka Bioscience to develop molecular assays and portable instruments for biopharmaceutical production. Roka Bioscience was recently 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 more sensitive tests for contaminants commonly found in pharmaceutical and biotechnology manufacturing processes. Last year, they introduced the MilliPROBE® system, which combines Millipore’s sample-prep methodologies with Gen-Probe’s nucleic acid technologies into 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. “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,” says 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.”

The MilliPROBE system uses real-time transcription-mediated amplification technology to detect targeted microbial contamination within four hours compared to days or weeks required to generate results using traditional culture-based technology, according to Millipore. Faster detection allows biopharmaceutical manufacturers to take corrective action earlier in the production process thus improving operational efficiency and lowering manufacturing costs.