The newly updated General Chapter 2.6.7. Mycoplasmas, which has just been published in Issue 12.2 of the European Pharmacopoeia and will enter into force on 1 April 2026, has specified exactly the quality requirements for mycoplasma reference standard preparations.
These changes are crucial for ensuring the safety and quality of biopharmaceuticals and advanced therapy medicinal products (ATMPs).
The section on Nucleic acid amplification techniques (NAT) has been extensively revised to reflect the state of the art in science and technology. A limit of less than 10 is now proposed as the acceptance criterion for the GC/CFU ratio of reference preparations, unless otherwise justified.
To help you navigate these regulatory changes and support your quality control efforts, we offer the Mycosafe® Mycoplasma Reference Standards:
- Ready-to-Use Convenience: Eliminate preparation time with our easy-to-use formats, allowing you to focus on your testing.
- High Accuracy: Our calibrated strains provide precise detection, ensuring reliable results for your mycoplasma testing.
- Regulatory Compliance: Fully compliant with EMA, FDA, and PMDA standards, helping you meet all quality assurance requirements.
- Versatile Applications: Suitable for a wide range of testing methods, including PCR validation and routine quality control, making them ideal for diverse laboratory needs.
Available Strains:
- Mycoplasma pneumoniae
- Mycoplasma orale
- Acholeplasma laidlawii
- Mycoplasma hyorhinis
- Mycoplasma fermentans
- Mycoplasma salivarium
- Mycoplasma arginini
- Spiroplasma citri
- Mycoplasma gallisepticum
- Mycoplasma synoviae
Are you searching for mycoplasma standards or an alternative to the ones you are using? Contact us!
