Bioprocess: Robustness with Respect to Mycoplasma Species

Talia Faison; Julie Wang; Sarah Johnson; Matthew Brown; Meng-Jung Chiang; Sherri Dolan; Carl Breuning; Sai Rashmika Velugula-Yellela; Scott Lute; Erica J. Fratz-Berilla; Kurt Brorson

doi:10.5731/pdajpst.2018.009613

References

1.↵
1. Razin S.,
2. Hayflick L.
Highlights of Mycoplasma Research–an Historical Perspective. Biologicals 2010, 38 (2), 183–190.
OpenUrl CrossRef PubMed
2.↵
1. Hay R. J.
Operator-Induced Contamination in Cell Culture Systems. Dev. Biol. Stand. 1991, 75, 193–204.
OpenUrl PubMed
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.
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.
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.
OpenUrl Abstract/FREE Full Text
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.
OpenUrl
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.
OpenUrl CrossRef PubMed Web of Science
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.
OpenUrl Abstract/FREE Full Text
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.
OpenUrl Abstract/FREE Full Text
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.
OpenUrl
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).
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.
OpenUrl PubMed
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.
OpenUrl CrossRef PubMed
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.
OpenUrl
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.
OpenUrl
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.
OpenUrl Abstract/FREE Full Text
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.
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.
OpenUrl
19.↵
ASTM International, ASTM E2888-12 (2012) Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. ASTM: West Conshohocken, PA, 2012.
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.
OpenUrl CrossRef PubMed Web of Science
21.↵
1. Citti C.,
2. Blanchard A.
Mycoplasmas and Their Host: Emerging and Re-Emerging Minimal Pathogens. Trends Microbiol. 2013, 21 (4), 196–203.
OpenUrl CrossRef PubMed
22.↵
1. Rottem S.,
2. Barile M. F.
Beware of Mycoplasmas. Trends Biotechnol. 1993, 11 (4), 143–151.
OpenUrl CrossRef PubMed Web of Science

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Keywords

[1] 1.↵
Razin S.,
Hayflick L.
Highlights of Mycoplasma Research–an Historical Perspective. Biologicals 2010, 38 (2), 183–190.
OpenUrl CrossRef PubMed

[2] Razin S.,

[3] Hayflick L.

[4] 2.↵
Hay R. J.
Operator-Induced Contamination in Cell Culture Systems. Dev. Biol. Stand. 1991, 75, 193–204.
OpenUrl PubMed

[5] Hay R. J.

[6] 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.

[7] 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.

[8] 5.↵
Wang J.,
Johnson S.,
Brown M.,
Lute S.,
Agarabi C.,
Dabrazhynetskaya A.,
Chizhikov V.,
Brorson K.
Mycoplasma Clearance and Risk Analysis in a Model Bioprocess. PDA J. Pharm. Sci. Technol. 2017, 71 (2), 99–114.
OpenUrl Abstract/FREE Full Text

[9] Wang J.,

[10] Johnson S.,

[11] Brown M.,

[12] Lute S.,

[13] Agarabi C.,

[14] Dabrazhynetskaya A.,

[15] Chizhikov V.,

[16] Brorson K.

[17] 6.↵
Dabrazhynetskaya A.,
Furtak V.,
Volokhov D.,
Beck B.,
Chizhikov V.
Preparation of Reference Stocks Suitable for Evaluation of Alternative NAT-Based Mycoplasma Detection Methods. J. Appl. Microbiol. 2014, 116 (1), 100–108.
OpenUrl

[18] Dabrazhynetskaya A.,

[19] Furtak V.,

[20] Volokhov D.,

[21] Beck B.,

[22] Chizhikov V.

[23] 7.↵
Drexler H. G.,
Uphoff C. C.
Mycoplasma Contamination of Cell Cultures: Incidence, Sources, Effects, Detection, Elimination, Prevention. Cytotechnology 2002, 39 (2), 75–90.
OpenUrl CrossRef PubMed Web of Science

[24] Drexler H. G.,

[25] Uphoff C. C.

[26] 8.↵
Lazarev V. N.,
Levitskii S. A.,
Basovskii Y. I.,
Chukin M. M.,
Akopian T. A.,
Vereshchagin V. V.,
Kostrjukova E. S.,
Kovaleva G. Y.,
Kazanov M. D.,
Malko D. B.,
Vitreschak A. G.,
Sernova N. V.,
Gelfand M. S.,
Demina I. A.,
Serebryakova M. V.,
Galyamina M. A.,
Vtyurin N. N.,
Rogov S. I.,
Alexeev D. G.,
Ladygina V. G.,
Govorun V. M.
Complete Genome and Proteome of Acholeplasma laidlawii. J. Bacteriol. 2011, 193 (18), 4943–4953.
OpenUrl Abstract/FREE Full Text

[27] Lazarev V. N.,

[28] Levitskii S. A.,

[29] Basovskii Y. I.,

[30] Chukin M. M.,

[31] Akopian T. A.,

[32] Vereshchagin V. V.,

[33] Kostrjukova E. S.,

[34] Kovaleva G. Y.,

[35] Kazanov M. D.,

[36] Malko D. B.,

[37] Vitreschak A. G.,

[38] Sernova N. V.,

[39] Gelfand M. S.,

[40] Demina I. A.,

[41] Serebryakova M. V.,

[42] Galyamina M. A.,

[43] Vtyurin N. N.,

[44] Rogov S. I.,

[45] Alexeev D. G.,

[46] Ladygina V. G.,

[47] Govorun V. M.

[48] 9.↵
Weisburg W. G.,
Tully J. G.,
Rose D. L.,
Petzel J. P.,
Oyaizu H.,
Yang D.,
Mandelco L.,
Sechrest J.,
Lawrence T. G.,
Van Etten J.,
Maniloff J.,
Woese C. R.
A Phylogenetic Analysis of the Mycoplasmas: Basis for Their Classification. J. Bacteriol. 1989, 171 (12), 6455–6467.
OpenUrl Abstract/FREE Full Text

[49] Weisburg W. G.,

[50] Tully J. G.,

[51] Rose D. L.,

[52] Petzel J. P.,

[53] Oyaizu H.,

[54] Yang D.,

[55] Mandelco L.,

[56] Sechrest J.,

[57] Lawrence T. G.,

[58] Van Etten J.,

[59] Maniloff J.,

[60] Woese C. R.

[61] 10.↵
Bae J. E.,
Jeong E. K.,
Lee J. I.,
Kim I. S.,
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.
OpenUrl

[62] Bae J. E.,

[63] Jeong E. K.,

[64] Lee J. I.,

[65] Kim I. S.,

[66] Kim J.-S.

[67] 11.↵
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).

[68] Bergmann K.

[69] 12.↵
Kurth J.,
Waldmann R.,
Heith J.,
Mausbach K.,
Burian R.
Efficient Inactivation of Viruses and Mycoplasma in Animal Sera Using UVC Irradiation. Dev. Biol. Stand. 1999, 99, 111–118.
OpenUrl PubMed

[70] Kurth J.,

[71] Waldmann R.,

[72] Heith J.,

[73] Mausbach K.,

[74] Burian R.

[75] 13.↵
Brough H.,
Antoniou C.,
Carter J.,
Jakubik J.,
Xu Y.,
Lutz H.
Performance of a Novel Viresolve NFR Virus Filter. Biotechnol. Prog. 2002, 18 (4), 782–795.
OpenUrl CrossRef PubMed

[76] Brough H.,

[77] Antoniou C.,

[78] Carter J.,

[79] Jakubik J.,

[80] Xu Y.,

[81] Lutz H.

[82] 14.↵
Mann K.,
Royce J.,
Carbrello C.,
Smith R.,
Zhu R.-R.,
Zeng Y.,
Leahy A.,
Priest M.,
Raman V.,
Nick Harrington J. S.,
Bliss S.,
Bryant W.,
Nguyen N.,
Le S.,
DeCesaro D.,
Perreault J.,
Goddard P.,
Orlando J.,
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.
OpenUrl

[83] Mann K.,

[84] Royce J.,

[85] Carbrello C.,

[86] Smith R.,

[87] Zhu R.-R.,

[88] Zeng Y.,

[89] Leahy A.,

[90] Priest M.,

[91] Raman V.,

[92] Nick Harrington J. S.,

[93] Bliss S.,

[94] Bryant W.,

[95] Nguyen N.,

[96] Le S.,

[97] DeCesaro D.,

[98] Perreault J.,

[99] Goddard P.,

[100] Orlando J.,

[101] Rautio K.

[102] 15.↵
Velugula-Yellela S. R.,
Williams A.,
Trunfio N.,
Hsu C.-J.,
Chavez B.,
Yoon S.,
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.
OpenUrl

[103] Velugula-Yellela S. R.,

[104] Williams A.,

[105] Trunfio N.,

[106] Hsu C.-J.,

[107] Chavez B.,

[108] Yoon S.,

[109] Agarabi C.

[110] 16.↵
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.
Lute S.,
Riordan W.,
Pease L. F. III.,
Tsai D. H.,
Levy R.,
Haque M.,
Martin J.,
Moroe I.,
Sato T.,
Morgan M.,
Krishnan M.,
Campbell J.,
Genest P.,
Dolan S.,
Tarrach K.,
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.
OpenUrl Abstract/FREE Full Text

[111] Zachariah M. R.,

[112] Tarlov M. J.,

[113] Etzel M.,

[114] Brorson K.,

[115] Aranha H.,

[116] Bailey M.,

[117] Bender J.,

[118] Carter J.,

[119] Chen Q.,

[120] Dowd C.,

[121] Jani R.,

[122] Jen D.,

[123] Kidd S.,

[124] Meltzer T.,

[125] Remington K.,

[126] Rice I.,

[127] Romero C.,

[128] Jornitz M.,

[129] Sekura C. M.,

[130] Sofer G.,

[131] Specht R.,

[132] Wojciechowski P.

[133] Lute S.,

[134] Riordan W.,

[135] Pease L. F. III.,

[136] Tsai D. H.,

[137] Levy R.,

[138] Haque M.,

[139] Martin J.,

[140] Moroe I.,

[141] Sato T.,

[142] Morgan M.,

[143] Krishnan M.,

[144] Campbell J.,

[145] Genest P.,

[146] Dolan S.,

[147] Tarrach K.,

[148] Meyer A.

[149] 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.

[150] 18.↵
Miesegaes G.,
Bailey M.,
Willkommen H.,
Chen Q.,
Roush D.,
Blumel J.,
Brorson K.
Proceedings of the 2009 Viral Clearance Symposium. Dev. Biol. (Basel, Switz.) 2010, 133, 3–101.
OpenUrl

[151] Miesegaes G.,

[152] Bailey M.,

[153] Willkommen H.,

[154] Chen Q.,

[155] Roush D.,

[156] Blumel J.,

[157] Brorson K.

[158] 19.↵
ASTM International, ASTM E2888-12 (2012) Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. ASTM: West Conshohocken, PA, 2012.

[159] 20.↵
Rosengarten R.,
Citti C.,
Glew M.,
Lischewski A.,
Droeße M.,
Much P.,
Winner F.,
Brank M.,
Spergser J.
Host-Pathogen Interactions in Mycoplasma Pathogenesis: Virulence and Survival Strategies of Minimalist Prokaryotes. Int. J. Med. Microbiol. 2000, 290 (1), 15–25.
OpenUrl CrossRef PubMed Web of Science

[160] Rosengarten R.,

[161] Citti C.,

[162] Glew M.,

[163] Lischewski A.,

[164] Droeße M.,

[165] Much P.,

[166] Winner F.,

[167] Brank M.,

[168] Spergser J.

[169] 21.↵
Citti C.,
Blanchard A.
Mycoplasmas and Their Host: Emerging and Re-Emerging Minimal Pathogens. Trends Microbiol. 2013, 21 (4), 196–203.
OpenUrl CrossRef PubMed

[170] Citti C.,

[171] Blanchard A.

[172] 22.↵
Rottem S.,
Barile M. F.
Beware of Mycoplasmas. Trends Biotechnol. 1993, 11 (4), 143–151.
OpenUrl CrossRef PubMed Web of Science

[173] Rottem S.,

[174] Barile M. F.

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Bioprocess: Robustness with Respect to Mycoplasma Species

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