New Rapid Mycoplasma Test Delivers Speed, Sensitivity And Specificity

Lancaster, PA - Eurofins Lancaster Laboratories has launched a new validated Rapid Mycoplasma Detection Test, overcoming time-consuming challenges of the standard 28-day compendial method for mycoplasma testing. For GMP and non-GMP assays, Eurofins Lancaster Laboratories can now deliver 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.

Mycoplasma contamination of cell lines used to produce biopharmaceutical products can disrupt cellular growth and metabolism and lead to changes in gene expression, resulting in decreased product quantity and quality. For these reasons, worldwide regulatory agencies require that biotechnological products produced in cell substrates be tested to ensure the absence of mycoplasma contamination. “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 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.

For more information, contact Cliff Schorr: cschorr@lancasterlabs.com

About Eurofins Lancaster Laboratories
Founded in 1961, Eurofins Lancaster Laboratories is one of the largest commercial contract laboratories in the world, providing comprehensive laboratory services in the pharmaceutical, biopharmaceutical, food and environmental sciences. Eurofins Lancaster Laboratories serves clients from a diverse range of businesses and industries, including Fortune 100 Industrial companies, the world’s largest pharmaceutical/biopharmaceutical companies as well as local and national governments. With facilities in Lancaster, Pennsylvania and Dungarvan, Ireland, Eurofins Lancaster Laboratories has a global capacity of 260,000 square feet and employs 1,200 employees worldwide.

Eurofins Lancaster Laboratories is part of Eurofins Scientific.
Eurofins Scientific is the world leader in environmental laboratory services, food and bio/pharmaceutical products testing and a global market leader in agroscience, genomics and central laboratory services. With over 12,000 staff in more than 170 laboratories across 32 countries, Eurofins offers a portfolio of over 100,000 reliable analytical methods for evaluating the safety, identity, composition, authenticity, origin and purity of biological substances and products. As one of the most innovative and quality oriented international players in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the expanding demands of regulatory authorities around the world.