Rapid mycoplasma testing achieves faster results
Eurofins Lancaster Laboratories’ new validated Rapid Mycoplasma Detection Test overcomes time-consuming challenges of the standard 28-day compendial method for mycoplasma testing. For GMP and non-GMP assays, Eurofins Lancaster Laboratories now delivers same-day preliminary results, while ensuring rapid, robust and reliable culture-free mycoplasma detection that is less prone to matrix interferences. To execute this rapid technology, Eurofins Lancaster Laboratories uses EMD Millipore’s MilliPROBE® Real Time Detection System for Mycoplasma.
“Traditional mycoplasma testing procedures are time consuming, requiring a 28-day duration; however, this time requirement is not amenable for obtaining the rapid lot release testing results needed for biopharmaceutical products that have short half-lives or those that are in high market demand,” says Dr. Jeri Ann Boose, Director of Biopharmaceutical Services at Eurofins Lancaster Laboratories. “The lengthy assay period is also not conducive to the rapid screening of raw materials intended for use in future production, nor to the rapid in-process screening of intermediates for the purpose of detecting and containing contamination events. Our new assay eliminates clients’ fast turnaround time challenges.”
Meeting European Pharmacopeia 2.6.7 guidelines, Eurofins Lancaster Laboratories’ new rapid mycoplasma test is comparable in sensitivity to the 28-day culture-based compendial method. And the EMD Millipore’s MilliPROBE® Real Time Detection System has the capability of processing a volume of material comparable to that tested in the compendial method, making it preferable to rapid mycoplasma detection methods that have volume limitations. In addition, the system incorporates features that allow it to preferentially detect viable mycoplasmas.