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Willard Sun, Technical Sales Manager, Eurofins BioPharma Product Testing Shanghai, willard.sun@cpt.eurofinscn.com

Mycoplasma is a common type of cell line contamination that may affect the manufacture of bioproducts, so it should be carefully controlled throughout the bioprocess. Contamination with mycoplasma is traditionally detected by direct or indirect culture-based methods. However, these methods will take several weeks to yield results, so the step is increasingly seen as a bottleneck for releasing bioproducts. There is therefore a need for rapid alternative methods with a comparable sensitivity, specificity and species range, and the NAT method is becoming more and more accepted by biopharma companies in this regard. Several commercially available kits for mycoplasma detection exist on the market; these kits can detect less than 10 CFU of the most frequently encountered mycoplasma contaminants in mammalian cell cultures.

Before these kits can be used as a routine test in the production of cell culture-based biologicals, validation according to the pharmacopeias is a must, especially the European Pharmacopoeia and Japanese Pharmacopoeia. Eurofins BPT Shanghai collected all mycoplasma needed in the Ph. Eur. <2.6.7> and successfully set up a platform to help clients perform mycoplasma detection and qPCR method validation, including the culture-based method comparison component.

Eurofins BPT Shanghai Laboratory specializes in mycoplasma comparable validation services, which provide customers with a more comprehensive testing solution and more accurate test results in a shorter period of time. EBPT Shanghai can support the validation of all kinds of NAT method mycoplasma testing kits, such as:

Specificity: The ability to correctly determine mycoplasma in the presence of other components (e.g., foreign bacterial contamination, cell matrix, and host cells).

Detection limit: The limitation to detect all kinds of mycoplasma. In Ph. Eur. <2.6.7>, it is required that each dilution of each mycoplasma has 24 detection data, and the positive rate of detection needs to meet more than 95% in order to be used as the detection limit.

Robustness: Whether the measurement results are affected when the measurement conditions are slightly changed. For more information, contact: BPTSH@cpt.eurofinscn.com