Mycosafe®: Mycoplasma Control for Quality Assurance
Mycoplasma Reference Standard Strains
Validation Standards & Controls according to EP, USP, JP and ChP Requirements for Application in NAT- & Culture-based Mycoplasma Testing of 'Classical' Biopharmaceuticals and ATMPs in Pharma QC, Cell & Gene Therapies, and Regenerative Medicine

Mycosafe® reference standard strains, developed by Prof. Renate Rosengarten, are specifically designed to address the critical issue of mycoplasma contamination in biopharmaceutical production and cell culture systems. These standardized strains serve as a reliable and validated resource for quality control and assurance, ensuring compliance with regulatory requirements.
Characterized by their low genome copy number to colony-forming unit (GC/CFU) ratios, Mycosafe® strains enhance the sensitivity and accuracy of detection methods, including PCR. Additionally, they offers heat-inactivated strains, providing a safe alternative for testing in environments where handling live mycoplasma cells may pose contamination risks.
By offering ready-to-use preparations, Mycosafe® reference standard strains streamline laboratory workflows, reduce contamination risks, and support the rapid and effective testing of biologics and cell therapies. Their adoption is essential for maintaining product integrity and ensuring patient safety in the rapidly evolving biopharmaceutical landscape.
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