Mycoplasma testing: regulatory guidance and strategies for cGMP cell and gene therapy manufacturing

Mycoplasma, the smallest known free-living, self-replicating microorganisms, are potential contaminants of mammalian cell cultures, including biotherapeutic manufacturing cell cultures. As such, these cultures must be tested and are required to be free of Mycoplasma. Regulatory guidance globally for Mycoplasma testing has evolved, from strictly requiring culture-based testing methods to now accepting rapid molecular methods, including real-time quantitative PCR-based methods. This poster details a highly sensitive, specific, and robust method for rapid Mycoplasma detection for lot-release and in-process testing

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