ATMPs represent one of the fast growing fields of novel therapies that are based on genes, tissues or cells. These highly innovative medicines offer revolutionary new prospects for the treatment of diseases or injuries. However, it is critical to maintain the quality and safety of ATMPs throughout the production cycle. One important aspect is avoiding mycoplasma contamination.
Mycoplasmas are ubiquitous and practically invisible bacterial contamination of cell cultures, which can induce undesirable changes to cell cultures such as altered growth rates, morphological changes, chromosomal aberrations, and altered cell metabolism. Therefore, the complete batch of ATMPs must be discarded when mycoplasma contamination is present.
Mycoplasma contamination is most commonly detected by the traditional “cell culture” and “indicator cell” method. However, despite their effectiveness, the methods are time-consuming and laborious, which hinders the release of products with short shelf lives. In addition, it is critical to detect mycoplasma contamination during the manufacturing process as soon as possible, to ensure a quick intervention, saving time and resources. Therefore, rapid nucleic acid amplification techniques (NAT), as an alternative for this culture-based method, may be used for in-process control or batch releases (EP 2.6.7, USP <63>), which decreases time-to-results from weeks to hours.
In this application note, the validation of the MycoTOOL mycoplasma real-time PCR kit from Roche is described, in which the matrix, sensitivity and specificity of the assay was tested. In a sample volume of 1 mL, we were able to recognize all the mycoplasma species at 10 CFU/mL as required by the EP 2.6.7. Using the NAT-based PCR method, we can offer fast, reproducible and sensitive results for in-process control and product release testing of ATMPs.
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