Mycoplasma, small bacteria that lack cell walls, are a hard-to-detect contaminant of cell lines and biopharmaceuticals that can pose a serious biosafety concern to human health. The bacteria are found in the plant and animal tissues used in cell culture media and are too small to remove using standard filters. To compound matters, mycoplasma contamination can we very difficult to detect as the bacteria are invisible to microscopes and have little effect on cell culture parameters.

RSSL’s mycoplasma testing methods are carried out under GMP and to ICH, European Pharmacopoeia and United States Pharmacopoeia guidelines and can deliver rapid results in the same day, if required. We will work with you to ensure the quality and safety of your biologic, whether you need rapid results from one sample or are looking to test a number of samples over a period of time, for further information or to discuss your needs further please contact us.

Rapid Mycoplasma Testing for ATMP Manufacturers

RSSL is the first company to offer a same-day mycoplasma testing service in the United Kingdom, making us the ideal partner laboratory for the ATMP sector.

The challenges posed by mycoplasma are particularly acute for manufacturers of autologous cell and gene therapies and other advanced therapy medicinal products (ATMPs). Production of autologous ATMPs entails taking a sample from a patient, processing it and administering it back into the same patient within 15 days.

Many ATMPs cannot be sterilised, have a short shelf life and are produced in small batches, making them both susceptible to contamination and unsuitable for agar and broth or in vitro indicator cell culture testing methods, which take up to 28 days to deliver results.

RSSL uses regulatory accepted PCR methods which offers a far faster alternative to manufacturers of ATMPs and other biologics and is better suited to short turnaround times. Using automated DNA extraction technologies and its established sample handling and tracking processes, our biopharmaceutical team will provide results by 5pm when it receives a sample for testing by 9:30am. For further information or to discuss your needs please contact us.

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