Bioprocess: Robustness with Respect to Mycoplasma Species

References

1. 1.↵
   1. Razin S.,
   2. Hayflick L.

   Highlights of Mycoplasma Research–an Historical Perspective. Biologicals 2010, 38 (2), 183–190.

   OpenUrlCrossRefPubMedGoogle Scholar
2. 2.↵
   1. Hay R. J.

   Operator-Induced Contamination in Cell Culture Systems. Dev. Biol. Stand. 1991, 75, 193–204.

   OpenUrlPubMedGoogle Scholar
3. 3.↵
   U.S. Food and Drug Administration, Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals, Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 1993.

   Google Scholar
4. 4.↵
   Council of Europe, Mycoplasmas, Chapter 2.6.7. In European Pharmacopoeia (Ph. Eur.), 6th Edition, Council of Europe: Strasbourg, France, 2007; pp 149–152.

   Google Scholar
5. 5.↵
   1. Wang J.,
   2. Johnson S.,
   3. Brown M.,
   4. Lute S.,
   5. Agarabi C.,
   6. Dabrazhynetskaya A.,
   7. Chizhikov V.,
   8. Brorson K.

   Mycoplasma Clearance and Risk Analysis in a Model Bioprocess. PDA J. Pharm. Sci. Technol. 2017, 71 (2), 99–114.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
6. 6.↵
   1. Dabrazhynetskaya A.,
   2. Furtak V.,
   3. Volokhov D.,
   4. Beck B.,
   5. Chizhikov V.

   Preparation of Reference Stocks Suitable for Evaluation of Alternative NAT-Based Mycoplasma Detection Methods. J. Appl. Microbiol. 2014, 116 (1), 100–108.

   OpenUrlGoogle Scholar
7. 7.↵
   1. Drexler H. G.,
   2. Uphoff C. C.

   Mycoplasma Contamination of Cell Cultures: Incidence, Sources, Effects, Detection, Elimination, Prevention. Cytotechnology 2002, 39 (2), 75–90.

   OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
8. 8.↵
   1. Lazarev V. N.,
   2. Levitskii S. A.,
   3. Basovskii Y. I.,
   4. Chukin M. M.,
   5. Akopian T. A.,
   6. Vereshchagin V. V.,
   7. Kostrjukova E. S.,
   8. Kovaleva G. Y.,
   9. Kazanov M. D.,
   10. Malko D. B.,
   11. Vitreschak A. G.,
   12. Sernova N. V.,
   13. Gelfand M. S.,
   14. Demina I. A.,
   15. Serebryakova M. V.,
   16. Galyamina M. A.,
   17. Vtyurin N. N.,
   18. Rogov S. I.,
   19. Alexeev D. G.,
   20. Ladygina V. G.,
   21. Govorun V. M.

   Complete Genome and Proteome of Acholeplasma laidlawii. J. Bacteriol. 2011, 193 (18), 4943–4953.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
9. 9.↵
   1. Weisburg W. G.,
   2. Tully J. G.,
   3. Rose D. L.,
   4. Petzel J. P.,
   5. Oyaizu H.,
   6. Yang D.,
   7. Mandelco L.,
   8. Sechrest J.,
   9. Lawrence T. G.,
   10. Van Etten J.,
   11. Maniloff J.,
   12. Woese C. R.

   A Phylogenetic Analysis of the Mycoplasmas: Basis for Their Classification. J. Bacteriol. 1989, 171 (12), 6455–6467.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
10. 10.↵
    1. Bae J. E.,
    2. Jeong E. K.,
    3. Lee J. I.,
    4. Kim I. S.,
    5. Kim J.-S.

    Evaluation of Viral Inactivation Efficacy of a Continuous Flow Ultraviolet-C Reactor (UVivatec). Korean J. Microbiol. Biotechnol. 2009, 37 (4), 377–382.

    OpenUrlGoogle Scholar
11. 11.↵
    1. Bergmann K.

    UV-C Irradiation: A New Viral Inactivation Method for Biopharmaceuticals. Am. Pharm. Rev. 2014, 17 (6). https://www.americanpharmaceuticalreview.com/Featured-Articles/169257-UV-C-Irradiation-A-New-Viral-Inactivation-Method-for-Biopharmaceuticals (accessed June 20, 2018).

    Google Scholar
12. 12.↵
    1. Kurth J.,
    2. Waldmann R.,
    3. Heith J.,
    4. Mausbach K.,
    5. Burian R.

    Efficient Inactivation of Viruses and Mycoplasma in Animal Sera Using UVC Irradiation. Dev. Biol. Stand. 1999, 99, 111–118.

    OpenUrlPubMedGoogle Scholar
13. 13.↵
    1. Brough H.,
    2. Antoniou C.,
    3. Carter J.,
    4. Jakubik J.,
    5. Xu Y.,
    6. Lutz H.

    Performance of a Novel Viresolve NFR Virus Filter. Biotechnol. Prog. 2002, 18 (4), 782–795.

    OpenUrlCrossRefPubMedGoogle Scholar
14. 14.↵
    1. Mann K.,
    2. Royce J.,
    3. Carbrello C.,
    4. Smith R.,
    5. Zhu R.-R.,
    6. Zeng Y.,
    7. Leahy A.,
    8. Priest M.,
    9. Raman V.,
    10. Nick Harrington J. S.,
    11. Bliss S.,
    12. Bryant W.,
    13. Nguyen N.,
    14. Le S.,
    15. DeCesaro D.,
    16. Perreault J.,
    17. Goddard P.,
    18. Orlando J.,
    19. Rautio K.

    Protection of Bioreactor Culture from Virus Contamination by Use of a Virus Barrier Filter. BMC Proc. 2015, 9 (Suppl. 9), 14–19. P22.

    OpenUrlGoogle Scholar
15. 15.↵
    1. Velugula-Yellela S. R.,
    2. Williams A.,
    3. Trunfio N.,
    4. Hsu C.-J.,
    5. Chavez B.,
    6. Yoon S.,
    7. Agarabi C.

    Impact of Media and Antifoam Selection on Monoclonal Antibody Production and Quality Using a High Throughput Micro-Bioreactor System. Biotechnol. Prog. 2018, 34 (1), 262–270.

    OpenUrlGoogle Scholar
16. 16.↵
    1. Zachariah M. R.,
    2. Tarlov M. J.,
    3. Etzel M.,
    4. Brorson K.,
    5. Aranha H.,
    6. Bailey M.,
    7. Bender J.,
    8. Carter J.,
    9. Chen Q.,
    10. Dowd C.,
    11. Jani R.,
    12. Jen D.,
    13. Kidd S.,
    14. Meltzer T.,
    15. Remington K.,
    16. Rice I.,
    17. Romero C.,
    18. Jornitz M.,
    19. Sekura C. M.,
    20. Sofer G.,
    21. Specht R.,
    22. Wojciechowski P.

    1. Lute S.,
    2. Riordan W.,
    3. Pease L. F. III.,
    4. Tsai D. H.,
    5. Levy R.,
    6. Haque M.,
    7. Martin J.,
    8. Moroe I.,
    9. Sato T.,
    10. Morgan M.,
    11. Krishnan M.,
    12. Campbell J.,
    13. Genest P.,
    14. Dolan S.,
    15. Tarrach K.,
    16. Meyer A.

    ; PDA Virus Filter Task Force; Zachariah M. R., Tarlov M. J., Etzel M., Brorson K., Aranha H., Bailey M., Bender J., Carter J., Chen Q., Dowd C., Jani R., Jen D., Kidd S., Meltzer T., Remington K., Rice I., Romero C., Jornitz M., Sekura C. M., Sofer G., Specht R., Wojciechowski P.; A Consensus Rating Method for Small Virus-Retentive Filters. I. Method Development. PDA J. Pharm. Sci. Technol. 2008, 62 318–333.

    OpenUrlAbstract/FREE Full TextGoogle Scholar
17. 17.↵
    International Conference for Harmonisation, Quality Guideline Q5A: Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. ICH Geneva, 1997.

    Google Scholar
18. 18.↵
    1. Miesegaes G.,
    2. Bailey M.,
    3. Willkommen H.,
    4. Chen Q.,
    5. Roush D.,
    6. Blumel J.,
    7. Brorson K.

    Proceedings of the 2009 Viral Clearance Symposium. Dev. Biol. (Basel, Switz.) 2010, 133, 3–101.

    OpenUrlGoogle Scholar
19. 19.↵
    ASTM International, ASTM E2888-12 (2012) Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. ASTM: West Conshohocken, PA, 2012.

    Google Scholar
20. 20.↵
    1. Rosengarten R.,
    2. Citti C.,
    3. Glew M.,
    4. Lischewski A.,
    5. Droeße M.,
    6. Much P.,
    7. Winner F.,
    8. Brank M.,
    9. Spergser J.

    Host-Pathogen Interactions in Mycoplasma Pathogenesis: Virulence and Survival Strategies of Minimalist Prokaryotes. Int. J. Med. Microbiol. 2000, 290 (1), 15–25.

    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
21. 21.↵
    1. Citti C.,
    2. Blanchard A.

    Mycoplasmas and Their Host: Emerging and Re-Emerging Minimal Pathogens. Trends Microbiol. 2013, 21 (4), 196–203.

    OpenUrlCrossRefPubMedGoogle Scholar
22. 22.↵
    1. Rottem S.,
    2. Barile M. F.

    Beware of Mycoplasmas. Trends Biotechnol. 1993, 11 (4), 143–151.

    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar