Millipore, the leading lab technology major has introduced the Milliprobe Detection System for Mycoplasma. The product is an outcome of the company's 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 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 launch of our new 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, Millipore's Bioprocess Division.
The system builds on the company's strength in mycoplasma risk management. It integrates industry-leading sample preparation technologies and testing expertise with core molecular diagnostics technologies developed by Gen-Probe, Incorporated.
Mycoplasma is a small, slow-growing and self-replicating bacteria that is extremely difficult to detect and eliminate from biopharmaceutical manufacturing processes. This Mycoplasma contamination can have costly consequences for biopharmaceutical manufacturers because it destroys an entire drug batch and shut down production facilities for an extended period when mycoplasma contamination is detected.
The product can be operated by technicians with limited molecular training, while meeting the stringent requirements of the biopharmaceutical quality control lab," said Roland Heinrich, Millipore Vice President, Process Monitoring.
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.