- Mycosafe® reference standard strains streamline laboratory workflows, reduce contamination risks, and support the rapid and effective testing of biologics and cell therapies.
- Reliable and validated, Mycosafe® reference standard strains are ideal for quality control and assurance, ensuring compliance with regulatory requirements.
Mycoplasma contamination is a significant concern in the biopharmaceutical industry, particularly in the production of biologics and cell therapies. These small bacteria can compromise the integrity of cell cultures and lead to serious quality control issues.
Regulatory bodies such as the FDA, EMA, and JP provide guidelines for mycoplasma testing. These guidelines specify the required methods, validation processes, and acceptable limits for mycoplasma levels in pharmaceutical products. Compliance with these regulations is crucial for product approval and market access.
Among the methods described in the pharmacopoeias, the ones based on nucleic acid testing (NAT) are being adopted more and more as they provide faster results than compendial growth-based methods.
However these alternative methods require considerable validation effort to demonstrate that they are comparable to the growth-based methods with respect to sensitivity and reliability before they can be implemented as a routine QC release test.
One of the challenges is to demonstrate the limit of detection of the method, which must be less than or equal to 10 CFU/mL as per pharmacopoeia requirements. Furthermore, the relationship between the amount of genetic material and the number of actual living mycoplasma cells in the sample, two variables that correlate, must be determined. This relationship can be characterized by the GC/CFU ratio, in which CFU represents the number of viable cells and GC the number of copies of genetic material present.
A low GC/CFU ratio ensures that the quantification of mycoplasma cells is accurate. Ideally it is around 1, in which case one genome copy indicates the presence of one living cell. This helps in validating PCR methods and ensures that the detected genetic material corresponds only to viable organisms, which is essential for effective contamination monitoring.
A determined GC/CFU ratio allows for comparability across different testing methods and laboratories, enhancing the reliability of results.
The upcoming revision of the Ph. Eur. 2.6.7 MYCOPLASMAS will specify quality requirements of mycoplasma strain preparations for the validation of nucleic acid amplification techniques. The GC/CFU ratio should be as low as possible and smaller than 10, unless otherwise justified.
Preparing an inoculum that matches these requirements is a challenge that requires skills in mycoplasma expansion, harvest and nucleic acid titration.
However, ready to use commercial preparations of CFU-calibrated and GC-titrated mycoplasma standard strains can ease the validation burden of alternative methods considerably.
Mycosafe® Mycoplasma Culture Reference Standards are ready-to-use low-GC/CFU cell suspensions of mycoplasmas in the mid-log growth phase. They can serve a wide range of quality control and other quantitative testing applications, and they are widely used particularly as validation standards and controls for implementing mycoplasma testing by real-time PCR. Originally made commercially available by Professor Rosengarten in 2012 under her trademark Mycosafe®, they are flash-frozen culture preparations of type and reference field strains of mycoplasma species that are required by regulation as test or positive control organisms for mycoplasma testing and/or that have additional product relevance as potential contaminants of 'classical' biopharmaceuticals and/or of advanced therapy medicinal products (ATMPs).
These ready-to-use, deep-frozen preparations of mycoplasma strains have a defined, low CFU (colony-forming units) or GC (genetic content) concentration.
They can be used for a variety of mycoplasma testing applications such as:
- Validation of routine mycoplasma PCR tests
- Generic and product specific validation of mycoplasma testing methods
- Growth promotion testing of culture media for mycoplasmas
- Disinfectant challenge tests
The Mycosafe® Mycoplasma Reference Standard portfolio comprises 10 mycoplasma strains in either viable or heat-inactivated format. These products are now distributed by Merck.
By enhancing the reliability and efficiency of PCR assays, these strains contribute significantly to the overall safety and quality of biologics and cell therapies. As the industry continues to evolve, the integration of advanced testing methods and standardized reference materials will be essential for maintaining high standards of quality control and regulatory compliance.
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