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      A Rapid and Sensitive Nucleic Acid Amplification Technique for Mycoplasma Screening of Cell Therapy Products

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          Abstract

          Mycoplasma species (spp.) bacteria can infect cell cultures, posing a potential threat to recipients of cell therapy products. Conventional Mycoplasma testing methods are highly sensitive but typically require a minimum of 28 days to produce results. This delay is problematic if rapid results are needed to inform treatment decisions. Nucleic acid amplification technique (NAT) methods have been gaining favor for Mycoplasma testing due to their speed and specificity; however, they must first be qualified as meeting or exceeding the sensitivity of the compendial method. We present herein a NAT method for the detection of Mycoplasma that circumvents the need for live Mycoplasma spp. in the test procedure by instead being qualified using Mycoplasma spp. genomic DNA. We have demonstrated a lower limit of detection that exceeds the regulatory requirements set by Health Canada. This assay is now being used to screen clinical cell therapy products manufactured at our center.

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          Mycoplasma contamination of cell cultures: Incidence, sources, effects, detection, elimination, prevention.

          Hans G. Drexler, Cord C. Uphoff (2002)
          The contamination of cell cultures by mycoplasmas remains a major problem in cell culture. Mycoplasmas can produce a virtually unlimited variety of effects in the cultures they infect. These organisms are resistant to most antibiotics commonly employed in cell cultures. Here we provide a concise overview of the current knowledge on: (1) the incidence and sources of mycoplasma contamination in cell cultures, the mycoplasma species most commonly detected in cell cultures, and the effects of mycoplasmas on the function and activities of infected cell cultures; (2) the various techniques available for the detection of mycoplasmas with particular emphasis on the most reliable detection methods; (3) the various methods available for the elimination of mycoplasmas highlighting antibiotic treatment; and (4) the recommended procedures and working protocols for the detection, elimination and prevention of mycoplasma contamination. The availability of accurate, sensitive and reliable detection methods and the application of robust and successful elimination methods provide powerful means for overcoming the problem of mycoplasma contamination in cell cultures.
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            Fatal outcome of a disseminated dual infection with drug-resistant Mycoplasma hominis and Ureaplasma parvum originating from a septic arthritis in an immunocompromised patient.

            Colin Mackenzie, Nicole Nischik, Rainer Kram … (2010)
            Mycoplasma hominis and Ureaplasma parvum are rare causes of severe and fatal infections. The diagnosis of infection with mycoplasma is dependent on clinical suspicion and microbiological diagnosis, and often relies on molecular methods that do not readily detect antibiotic resistance. This may be of increasing importance as illustrated in the case below. Copyright © 2010 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
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              The scope of mycoplasma contamination within the biopharmaceutical industry.

              Shayn E Armstrong, Jill A Mariano, Daniel Lundin (2010)
              Mycoplasma is well recognized as one of the most prevalent and serious microbial contaminants encountered within the manufacturing of biopharmaceuticals from the research phase to clinical development and production. The potential for mycoplasma contamination within cell culture systems was first identified by Robinson et al. in 1956. Presently, contamination rates in established cell cultures have been reported between 15 and 35% with considerably higher occurrence cited in certain selected populations. In the last few years, there has been an expansion of diagnostic approaches for mycoplasma detection with the development and validation of rapid microbiological methods. The objective of this study was to determine current levels of mycoplasma infection of cell cultures, cell substrates and biologicals within a client based population. Retrospective comparison of 40,000 sample results was done to determine total contaminations rates amongst four (4) individual analytical assays. The establishment of reference data, such as existing contamination rates, becomes important in the critical appraisal of rapid microbiological methods for the detection of mycoplasma.
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                Author and article information

                Contributors
                Robert A. Holt
                Journal
                Journal ID (nlm-ta): Mol Ther Methods Clin Dev
                Journal ID (iso-abbrev): Mol Ther Methods Clin Dev
                Title: Molecular Therapy. Methods & Clinical Development
                Publisher: American Society of Gene & Cell Therapy
                ISSN (Electronic): 2329-0501
                Publication date PMC-release: 30 January 2020
                Publication date Collection: 12 June 2020
                Publication date (Electronic): 30 January 2020
                Volume: 17
                Pages: 393-399
                Affiliations
                [1 ]Canada’s Michael Smith Genome Sciences Centre, BC Cancer, Vancouver, BC V5Z 1L3, Canada
                [2 ]Trev and Joyce Deeley Research Centre, BC Cancer, Victoria, BC V8R 6V5, Canada
                [3 ]Department of Biochemistry and Microbiology, University of Victoria, Victoria, BC V8W 2Y2, Canada
                [4 ]Department of Medical Genetics, University of British Columbia, Vancouver, BC V6T 1Z4, Canada
                [5 ]Terry Fox Laboratory, BC Cancer, Vancouver, BC V5Z 1L3, Canada
                [6 ]Department of Medicine, University of British Columbia, Vancouver, BC V6T 1Z3, Canada
                [7 ]Blood and Marrow Transplant Program, Ottawa Hospital Research Institute, Ottawa, ON K1H 8L6, Canada
                [8 ]Molecular Biology & Biochemistry, Simon Fraser University, Burnaby, BC V5A 1S6, Canada
                Author notes
                [∗ ]Corresponding author: Robert A. Holt, Canada’s Michael Smith Genome Sciences Centre, BC Cancer, Vancouver, BC V5Z 1L3, Canada. rholt@ 123456bcgsc.ca
                Article
                Publisher ID: S2329-0501(20)30020-6
                DOI: 10.1016/j.omtm.2020.01.009
                PMC ID: 7044503
                PubMed ID: 32128343
                SO-VID: 15dfd29e-7cbf-44be-bb42-e28f346b2fbb
                Copyright © © 2020 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 5 December 2019
                Date accepted : 17 January 2020
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                Subject: Article

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