Millipore has launched Milliprobe, a new system to detect mycoplasma contamination in the biopharmaceutical manufacturing.
Milliprobe is a 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 company said in a pres release.
Millipore has developed the Milliprobe mycoplasma detection system in collaboration with Roka Bioscience.
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 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 company said.
“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,” stated Jean-Paul Mangeolle, president, Millipore’s Bioprocess Division.
The mycoplasma risk management system integrates sample preparation technologies and testing expertise with core molecular diagnostics technologies developed by Gen-Probe, Incorporated.
Milliprobe can be operated by technicians with limited molecular training, while meeting the stringent requirements of the biopharmaceutical quality control lab, according 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.
Millipore is a Life Science firm providing technologies, tools, and services for bioscience research and biopharmaceutical manufacturing.