Assessing Rapid Mycoplasma Detection

Mycoplasmas, distinguishable by their lack of cell wall, pose a threat to biopharmaceuticals such as vaccines and biologics. Mycoplasma contamination remains to be a significant problem for basic investigations as well as for manufacturing of biologics. Their contaminations represent a serious issue in virology since cell lines are used for cell culture of animal viruses. Humans and particular animal species are natural hosts of contaminating mycoplasma species. Humans who handle cell culture infected by Mycoplasma fermentans, M. orale, and M. hominis Thanks to rigorous “in process” testing, the contamination has not made its way to patients. Despite the success of these obsolete cell culture testing methods, there is a downfall. The noticeable flaw is time and money. Compared to other bacteria, Mycoplasma may not be as easily detected due to its slow growth and may persist in cell cultures for a long period of time. The European Pharmacopoeia has acquired an alte ative method for replacing the laborious 30-day testing for detecting mycoplasma contaminants in biopharmaceutical samples. Moving away from the time consuming test for detecting mycoplasma contaminants, there are alte ative methods such as electron microscopy, infrared spectroscopy, and histochemical staining. Until more recently, polymerase chain reaction (PCR) technology have been developed and tailored toward the detection of mycoplasma contamination of cell cultures. Imagine a researcher could reduce the time required to scree Mycoplasma by nearly a month; from 1 month to a day. The most common contaminants of cell lines such as Mycoplasma bovis, M. fermentans, M. hyorhinis, M. hominis, M. orale, M. and Acholeplasma laidlawii would easily be detected along with 18 other Mycoplasma species. Cited in scientific literature, there are numerous PCR-based methods for detecting Mycoplasma. Moreover, there are good number of commercially available PCR-based assays, providing researchers and people alike the controls and reagents needed to perform the experiment. These assays in particular seem to have higher sensitivity for detecting Mycoplasma contamination compared to old cell culture methods. Not only can a researcher detect mycoplasma contamination at a much faster rate, assessment of more samples versus culture method is possible. PCR based methods can bring high assurance of contamination-free vaccines and biopharmaceuticals, and relief to the World Health Organization (WHO) and the Food & Drug Administration (FDA). The advantages of increasing the speed of workflow for detecting Mycoplasma contamination in bioproducts and reduction of cost should be valid reasons why manufacturers should explore and embrace PCR technology over the old culture methods. Demonstrating the performance and the time required for both rapid mycoplasma method and the currently approved culture method for the sake of comparison would push the advancement of old culture methods into the right direction for biopharmaceutical companies. You can also read more about Biosafety testing and Bioassay Development. This article is published on behalf of BioOutsource - Europe's fastest growing contract testing organization based in Glasgow, Scotland. Providing contract testing services including Biosimilars Testing, Biologics Testing, Bioassay Development and Vaccine testing services.