Mycoplasma contamination can cause chromosome aberrations and shifts in metabolism and cell growth. Ultimately, it can kill a cell line. In cases of contamination a company may have to destroy an entire batch of the therapeutic and shut down production facilities for an extended period.
To speed detection of the contaminant Millipore has extended its MilliPROBE product line to cover Mycoplasma identification. Using this system a biologic manufacturer can test more frequently and take corrective action sooner, potentially saving the company money.
MilliPROBE is the first tool for early-detection of Mycoplasma contamination, according to Millipore, and is designed to improve on the culture-based systems which have been in use.
These take 28 to 35 days to detect the contaminant, compared to four hours for MilliPROBE. Furthermore, MilliPROBE can be used by technicians with limited molecular training, while still meeting quality control requirements for biologics.
MilliPROBE range
The Mycoplasma detection system is the product of Millipore’s collaboration with Roka Bioscience, which spun-off from Gen-Probe, the original research partner, in September 2009.
In January 2008 the partners released an early-detection test for Pseudomonas aeruginosa, a bacterium found in purified water. Now, the MilliPROBE range has been expanded with the launch of the Mycoplasma detection system.
Roka contributed its background reduction technology to the product. This protects the assay from contamination which can cause false positives. Decreasing the likelihood of this occurring potentially saves the company from taking unnecessary, costly actions.
The detection system also uses Millipore’s sample preparation device. Millipore has designed this to handle complex bioreactor samples in larger volumes than alternative Mycoplasma testing systems can manage.