Rapid mycoplasma testing delivers sensitivity, specificity and speed to a broad scope of matrices

By Jeri Ann Boose, Ph.D., Eurofins Lancaster Laboratories, USA

Mycoplasmas are small, self-replicating prokaryotes that are common contaminants of mammalian cell culture. Mycoplasma contamination of cell lines used to produce biopharmaceutical products can disrupt cellular growth and metabolism and lead to changes in gene expression. These adverse cytopathological events can result in decreased product quantity and quality. As mycoplasma infections have been associated with numerous human diseases, world-wide regulatory agencies require that biotechnological products produced in cell substrates be tested to ensure the absence of mycoplasma contamination.

Current compendial mycoplasma testing procedures are 28 days in duration. This time requirement is not amenable for obtaining the rapid lot release testing results needed for biopharmaceutical products that have short half-lives or for which there is high market demand. The 28-day assay time is also not conducive to the rapid screening of raw materials used in production or to the rapid in-process screening of intermediates for the early detection of a mycoplasma contamination event.

Eurofins Lancaster Laboratories now offers the EMD Millipore MilliPROBE® Real Time Detection System for Mycoplasma, a rapid test comparable in sensitivity and specificity to the current 28-day compendial method. In addition to the fact that unaudited data can be sent the same day as testing, other advantages include the fact that the volume of material that can be put on test is comparable to that of the 28-day method and the fact that the method preferentially detects viable mycoplasmas. The system is also less prone to sample matrix effects than other commercially available rapid mycoplasma detection methods.

Eurofins, thanks to recent developments at Eurofins Lancaster Laboratories where they completed validation of the MilliPROBE® System this summer, has begun commercially offering both GMP and non-GMP versions of the assay to its international customers.
For more information, visit: http://pharm.lancasterlabs.com/biopharmaceutical/rapid-mycoplasma-testing

Contact: GMP_US@eurofins.com