It has been almost a year since we first wrote about the importance of controlling your cultures against the onset of Mycoplasma contamination, and the statements we made back then are just as – if not more – important right now. The statistics – that 25% of all cultures are contaminated with Mycoplasma, and the limitations – that Mycoplasma is very hard to detect with regular light microscopes – still hold. Between then and now, the scientific community has increasingly highlighted the importance of developing and validating new methods for the more efficient detection of Mycoplasma in cultures.
The European Pharmacopiea 2.6.7 Mycoplasmas specifies the requirements for the validation of a nucleic acid-based test for Mycoplasmas. Because the potential consequences of Mycoplasma-contaminated cultures are significant, implementing rapid methods for the testing of cell therapy products can accelerate their validation and release, which is of significant therapeutic and commercial benefit.
With this in mind, the European Medicines Agency (EMA) approved a real time polymerase chain reaction (Real-Time PCR) Mycoplasma test in June 2013 for the testing and release of a lot of matrix-applied characterized autologous cultured chondrocytes (MACI®) which were approved back in April of the same year.
Mycoplasma RT-PCR detection systems are becoming more commonplace as an increasing number of scientific papers reports on their efficacy and speed. Regulatory agencies and validation programs are beginning to see the benefits that these detection systems bring and will begin incorporating them more thoroughly as part of release tests for cell therapy programs.
On 9 December 2014, the European Compliance Academy is hosting a Mycoplasma Testing Conference in Heidelberg, Germany which will feature many prominent speakers and companies. The one-day meeting will highlight new technologies for the detection of Mycoplasmas and the current research in the area, where RT-PCR systems are expected to take a central role.
With the above in mind, it is clear that containing Mycoplasma contamination is a critical aspect of cell therapy product development, and the awareness of the need for improved, more rapid detection approaches that will streamline the release process for cell therapies. We are curious to hear about your experiences with Mycoplasma contamination: do you think about it and how big of a part of your R&D/cell therapy process development scheme does it occupy? Write us or share your thoughts in the comments.
Finally, don’t forget to check out Akron’s own, industry-leading Mycosolutions RT-PCR kit, which will be available the first week of October.