Development and validation of a multiplex quantitative polymerase chain reaction assay for the detection of Mollicutes impurities in human cells, cultured under good manufacturing practice conditions, and following European Pharmacopoeia requirements and the International Conference on Harmonization guidelines

References

• Razin S, Hayflick L. Highlights of mycoplasma research: an historical perspective. Biologicals. 2010;38:183–90.
   Google Scholar
• Shahhosseiny MH, Hosseiny Z, Khoramkhorshid HR, Azari S, Shokrgozar MA. Rapid and sensitive detection of Mollicutes in cell culture by polymerase chain reaction. J Basic Microbiol. 2010;50:171–8.
   Google Scholar
• Uphoff CC, Drexler HG. Detection of mycoplasma contaminations. Methods Mol Biol. 2005;290:13–23.
   Google Scholar
• Uphoff CC, Drexler HG. Eradication of mycoplasma contaminations. Methods Mol Biol. 2005;290:25–34.
   Google Scholar
• Drexler HG, Uphoff CC. Mycoplasma contamination of cell cultures: incidence, sources, effects, detection, elimination, prevention. Cytotechnology. 2002;39:75–90.
   PubMed Web of Science ®Google Scholar
• Rawadi G, Dussurget O. Advances in PCR-based detection of mycoplasmas contaminating cell cultures. PCR Methods Appl. 1995;4:199–208.
   Google Scholar
• Rottem S, Naot Y. Subversion and exploitation of host cells by mycoplasmas. Trends Microbiol. 1998;6:436–40.
   PubMed Web of Science ®Google Scholar
• Gorin NC. Autologous stem cell transplantation for adult acute leukemia. Curr Opin Oncol. 2002;14:152–9.
   PubMed Web of Science ®Google Scholar
• Li Pira G, Ivaldi F, Tripodi G, Martinengo M, Manca F. Positive selection and expansion of cytomegalovirus-specific CD4 and CD8 T cells in sealed systems: potential applications for adoptive cellular immunoreconstitution. J Immunother. 2008;31:762–70.
   Google Scholar
• World Health Organization. Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. 32nd report. WHO Technical Report Series No. 823. Geneva: World Health Organization; 1992. Annex 1.
   Google Scholar
• European Union. Directive 2004/23/EC of the European Parliament and of the Council on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells. Official Journal of the European Union; Strasbourg, 31 March 2004.
   Google Scholar
• Zoon KC, Food and Drug Administration Points to Consider in the Characterization of Cell Lines used to Produce Biologicals. 21 CFR 610.30. Food and Drug Administration, Bethesda, MD, USA. 1993. http://www.fda.gov/cber/gdlns/ptccell.pdf. Accessed 24 May 2005.
   Google Scholar
• International Conference on Harmonization. ICH Q2 (R1) validation of analytical procedure: text and methodology. In: Proceedings of the International Conference on Harmonization, Geneva, 1995. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1_Guideline.pdf
   Google Scholar
• Razin S, Yogev D, Naot Y. Molecular biology and pathogenicity of mycoplasmas. Microbiol Mol Biol Rev. 1998;62: 1094–156.
   PubMed Web of Science ®Google Scholar
• Young L, Sung J, Stacey G, Masters JR. Detection of Mycoplasma in cell cultures. Nat Protoc. 2010;5:929–34.
   PubMed Web of Science ®Google Scholar
• Loens K, Ursi D, Goossens H, Ieven M. Molecular diagnosis of Mycoplasma pneumoniae respiratory tract infections. J Clin Microbiol. 2003;41:4915–23.
   PubMed Web of Science ®Google Scholar
• Harris R, Marmion BP, Varkanis G, Kok T, Lunn B, Martin J. Laboratory diagnosis of Mycoplasma pneumoniae infection. II. Comparison of methods for the direct detection of specific antigen or nucleic acid sequences in respiratory exudates. Epidemiol Infect. 1988;101:685–94.
   PubMed Web of Science ®Google Scholar
• Volokhov DV, Graham LJ, Brorson KA, Chizhikov VE. Mycoplasma testing of cell substrates and biologics: review of alternative non-microbiological techniques. Mol. Cell. Probes. 2011;1–9.
   Google Scholar
• European Directorate for the Quality of Medicines (EDQM), Council of Europe, Strasbourg, France. European pharmacopoeia 5.0. 2004 Section 2.6.7. Mycoplasma.
   Google Scholar
• Taylor S, Wakem M, Dijkman G, Alsarraj M, Nguyen M. A practical approach to RT-qPCR: publishing data that conform to the MIQE guidelines. Methods. 2010;50:S1–5.
   PubMed Web of Science ®Google Scholar
• Bustin SA, Benes V, Garson JA, Hellemans J, Huggett J, . The MIQE guidelines: minimum information for publication of quantitative real-time PCR experiments. Clin Chem. 2009;55:611–22.
   PubMed Web of Science ®Google Scholar
• Di Marco E, Cangemi G, Filippetti M, Melioli G, Biassoni R. Development and clinical validation of a real-time PCR using uni-molecular Scorpion-based probe for the detection of Mycoplasma pneumoniae in clinical isolates. New Microbiol. 2007;30:415–21.
   Google Scholar
• Zuker M. Mfold web server for nucleic acid folding and hybridization prediction. Nucleic Acids Res. 2003;31:3406–15.
   PubMed Web of Science ®Google Scholar
• Ropolo M, Daga A, Griffero F, Foresta M, Casartelli G, Zunino A, . Comparative analysis of DNA repair in stem and nonstem glioma cell cultures. Mol Cancer Res. 2009;7: 383–92.
   PubMed Web of Science ®Google Scholar
• Raso A, Negri F, Gregorio A, Nozza P, Mascelli S, De Marco P, . Successful isolation and long-term establishment of a cell line with stem cell-like features from an anaplastic medulloblastoma. Neuropathol Appl Neurobiol. 2008;34: 306–15.
   Google Scholar
• Boom R, Sol CJ, Salimans MM, Jansen CL, Wertheim-van Dillen PM, van der Noordaa J. Rapid and simple method for purification of nucleic acids. J Clin Microbiol. 1990;28: 495–503.
   PubMed Web of Science ®Google Scholar
• Kaur H, Arora A, Wengel J, Maiti S. Thermodynamic, counterion, and hydration effects for the incorporation of locked nucleic acid nucleotides into DNA duplexes. Biochemistry. 2006;45:7347–55.
   PubMed Web of Science ®Google Scholar
• USP32-NF27, General Chapter 1225, Validation of Compendial Methods, 2009.
   Google Scholar
• Harasawa R. Genetic relationships among mycoplasmas based on the 16S–23S rRNA spacer sequence. Microbiol Immunol. 1999;43:127–32.
   PubMed Web of Science ®Google Scholar
• Harasawa R, Kanamoto Y. Differentiation of two biovars of ureaplasma urealyticum based on the 16S–23S rRNA intergenic spacer region. J Clin Microbiol. 1999;37:4135–8.
   PubMed Web of Science ®Google Scholar
• McGarrity GJ, Kotani H. Detection of cell culture mycoplasmas by a genetic probe. Exp Cell Res. 1986 ;163:273–8.
   PubMed Web of Science ®Google Scholar
• Kong F, James G, Gordon S, Zelynski A, Gilbert GL. Species-specific PCR for identification of common contaminant Mollicutes in cell culture. Appl Environ Microbiol. 2001;67:3195–200.
   PubMed Web of Science ®Google Scholar
• Stormer M, Vollmer T, Henrich B, Kleesiek K, Dreier J. Broad-range real-time PCR assay for the rapid identification of cell-line contaminants and clinically important mollicute species. Int J Med Microbiol. 2009;299:291–300.
   Google Scholar
• Bove JM, Garnier M. In: Cassels AC. Developments in Plant Pathology, Pathogen and Microbial Contamination Management in Micropropagation. Dordrecht: Kluwer Academic Publishers; 1997. p. 45–60.
   Google Scholar