Mycosafe^® Mycoplasma Reference Standards

Mycosafe^® Mycoplasma Reference Standards, developed by Professor Renate Rosengarten, are specifically designed for validating mycoplasma detection methods and for use as positive controls in routine mycoplasma testing of 'classical' biopharmaceuticals and cell and gene therapy products by ensuring compliance with regulatory requirements. These reference standard preparations therefore serve as a reliable tool in quality control and quality assurance to address the critical issue of mycoplasma contamination in biopharmaceutical production and cell culture systems.

Characterized by a low ratio of genome copies (GC) to the total mycoplasma cells (in colony-forming units, CFU) confirming the scientific accuracy of their production process, Mycosafe^® Mycoplasma Reference Standards ensure an objective and unbiased comparability of NAT-based and culture-based mycoplasma detection methods, including Real-time PCR methods. Additionally, Mycosafe^® Mycoplasma Reference Standards are offered not only as viable but also as heat-inactivated cell preparations, which provide a safe alternative for mycoplasma testing in environments where handling live mycoplasma cells may pose contamination risks.

As ready-to-use commercial products, Mycosafe^® Mycoplasma Reference Standards streamline laboratory workflows and thus reduce contamination risks. They enable the implementation of rapid and reliable mycoplasma testing methods for biopharmaceutical and cell and gene therapy products, making them essential for maintaining product quality and ensuring patient safety in the rapidly evolving biopharmaceutical industry.

The Mycosafe^® Mycoplasma Reference Standards will be available soon! Connect with our experts to get notified when they're available or to get more information!