Optimizing capacity utilization by large scale 3000 L perfusion in seed train bioreactors

Biotechnology Progress

Volumn 29, Issue 1, 2013, Pages 222-229

  Pohlscheidt, Michael ^a   Jacobs, Melanie ^a   Wolf, Stefan ^a   Thiele, Joerg ^a   Jockwer, Alexander ^a   Gabelsberger, Josef ^a   Jenzsch, Marco ^a   Tebbe, Hermann ^a   Burg, Josef ^a  

^a ROCHE DIAGNOSTICS GMBH   (Germany)

Author keywords

Cell culture; Inclined settler; Large scale; Perfusion; Seed train

Indexed keywords

ANTIBODY MANUFACTURING; CAPACITY UTILIZATION; CELL DENSITY; CELL LINES; CELL RETENTION DEVICES; CGMP FACILITY; COST IMPROVEMENTS; FED BATCHES; INCLINED SETTLER; LARGE SCALE; MANUFACTURING COST; MEDIA FORMULATIONS; OPERATIONAL STRATEGIES; PERFUSION; PERFUSION RATE; PHARMACEUTICAL COMPANY; PRODUCT QUALITY; PRODUCTION CULTURE; RETENTION EFFICIENCIES;

BIOREACTORS; CELL CULTURE; CELLS; COMPETITION; CYTOLOGY; INNOVATION;

BATCH CELL CULTURE;

ANIMAL; ARTICLE; BIOREACTOR; CELL COUNT; CHO CELL; CRICETULUS; CULTURE TECHNIQUE; EQUIPMENT DESIGN; HAMSTER;

ANIMALS; BIOREACTORS; CELL COUNT; CELL CULTURE TECHNIQUES; CHO CELLS; CRICETINAE; CRICETULUS; EQUIPMENT DESIGN;

EID: 84873301460     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.1672     Document Type: Article

References (49)

1. Reichert JM. Monoclonal antibodies in the clinic. Nat Biotechnol. 2001; 19: 819-822.
2. Reichert JM. Therapeutic monoclonal antibodies: trends in development and approval in the US. Curr Opin Mol Ther. 2002; 4: 110-118.
3. Reichert JM, Pavolu A. Monoclonal antibodies market. Nat Rev Drug Discov. 2004; 3: 383-384.
4. Drapeau M, Sullivan F, Moniz Carpenter J. Special report: blockbuster then and now-trends for billion-dollar drugs. Spectrum Therapy Markets Emerging Technol. 2007; 12: 1-9.
5. Munos B. Lessons from 60 years of pharmaceutical innovation. Nat Rev. 2009; 8: 959-968.
6. Pohlscheidt M. Strategic Technology-Network-and Innovation Management. MBA Thesis, 2010; ETH Zurich, Switzerland.
7. Xie L, Wang DIC. Integrated approaches to the design of media and feeding strategies for fed batch cultures of animal cells. Trends Biotechnol. 1997; 15: 109-113.
8. Qi HN, Goudar CT, Michaels JD, Henzler HJ, Jovanovic GN, Konstantinov KB. Experimental and theoretical analysis of tubular membrane. Biotechnol Prog. 2003; 19: 1183-1189.
9. Wurm FM. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat Biotechnol. 2004; 22: 1393-1398.
10. Sethuramann N, Stadheim TA. Challenges in therapeutic glycoprotein production. Curr Opin Biotechnol. 2006; 17: 341-346.
11. Heath C, Kiss R. Cell culture process development: advances in process engineering. Biotechnol Prog. 2007; 23: 46-51.
12. Su WW. Bioreactors, Perfusion. Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology. Wiley; 2009: 1-17.
13. Shukla A, Thömmes J. Recent advances in large-scale production of monoclonal antibodies and related proteins. Trends Biotechnol. 2010; 28: 253-261.
14. Kompala D, Ozturk S. Optimization of high density perfusion bioreactors. In: Oztuk S, Hu W-S, editors. Cell Culture Technology for Pharmaceutical and Cellular Therapies. New York: Taylor and Francis; 2006: 349-416.
15. Voisard D, Meuwly F, Ruffieux PA, Baer G, Kadouri A. Potential of cell retention techniques for large-scale high-density perfusion culture of suspended mammalian cells. Biotechnol Bioeng. 2003; 82: 751-765.
16. Ryll T, Dutina G, Reyes A, Gunson J, Krummen L, Etcheverry T. Performance of small scale CHO perfusion cultures using an cell filtration device for cell retention: characterization of separation efficiency and impact of perfusion on product quality. Biotechnol Bioeng. 2000; 69: 440-449.
17. Woodside SM, Boweb BD, Piret JM. Mammalian cell retention devices for stirred perfusion bioreactors. Cytotechnology 1998; 28: 163-175.
18. Casthilo RC, Medrohno RA. Cell retention devices for suspended-cell perfusion cultures. Adv Biochem Eng Biotechnol. 2004; 74: 129-169.
19. Griffiths JB. Animal cell culture processes-batch or continuous? J Biotechnol. 1992; 22: 21-30.
20. Wang Z, Tan W, Poptic EJ, Belovich J. Feasibility of using a small-scale perfusion bioreactor with a novel cell retention device to inoculate a large-scale bioreactor. Conference Presentation at the American Chemical Society National Meeting, San Francisco, CA.
21. Chu L, Robinson DK. Industrial choices for protein production by large-scale cell culture. Curr Opin Biotechnol. 2001; 12: 180-187.
22. Henzler HJ. Kontinuierliche Fermentationmit tierischen Zellen-Teil 1: Aspekte der kontinuierlichen Prozessfuehrung. Chem Ingenieur Tech. 2012; 84: 1469-1481.
23. Henzler HJ. Kontinuierliche fermentationmit tierischen Zellen-Teil 2: Techniken und Methoden der Zellrueckhaltung. Chem Ingenieur Techn. 2012; 84: 1482-1496.
24. Kloth C, MacLsaaac G, Ghemrenariam H, Arunakumari A. Inoculum Expansion Methods, Recombinant Mammalian Cell Lines. Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation and Cell Technology. Wiley; 2010: 1-30.
25. Dowd JE, Jubb A, Kwok KE, Piret JM. Optimization and control of perfusion cultures using a viable cell probe and cell specific perfusion rates. Cytotechnology 2003; 42: 35-45.
26. Heidemann R, Mered M, Wang DQ, Gardner B, Zhang C, Michaels J, Henzler HJ, Abbas N, Konstantinov K. A new seed-train expansion method for recombinant mammalian cell lines. Cytotechnology 2002; 38: 99-108.
27. Dowd JE, Kwok KE, Piret JM. Glucose-based optimization of CHO-cell perfusion cultures. Biotechnol Bioeng 2001; 75: 252-256.
28. Wang MD, Yang M, Huzel N, Butler M. Erythropoietin production from CHO cells grown by continuous culture in a fluidized-bed bioreactor. Biotechnol Bioeng. 2002; 77: 194-202.
29. Lee JC, Chang HN, Oh DJ. Recombinant antibody production by perfusion cultures of rCHO cells in a depth filter perfusion system. Biotechnol Prog. 2005; 21: 134-139.
30. 2 in large-scale and high-density CHO cell perfusion culture. Cytotechnology 1996; 22: 65-78.
31. Smelko JP, Wiltberger KR, Hickman EF, Morris BJ, Blackburn TJ, Ryll T. Performance of high intensity fed-batch mammalian cell culture in disposable bioreactors. Biotechnol Prog 2011; 27: 1358-1364.
32. Lee JC, Chang HN, Oh DJ. Application of a cell-once-through perfusion strategy for production of recombinant antibody from rCHO cells in a centritech lab II centrifuge system. Biotechnol Prog 2007; 23: 1186-1197.
33. Tang YJ, Ohashi R, Hamel JFP. Perfusion culture of hybridoma cells for hyperproduction of igG2a monoclonal antibody in wave bioreactor-perfusion culture system. Biotechnol Prog 2007; 23: 255-264.
34. Searles JA, Todd P, Kompala DS. Viable cell recycle with an inclined settler in the perfusion culture of suspended recombinant Chinese hamster ovary cells. Biotechnol Prog 1994; 10: 198-206.
35. Pinto RCV, Medronho RA, Castilho LR. Separation of CHO cells using hydrocyclones. Cytotechnology 2008; 56: 57-67.
36. Avgerinos GC, Drapeu D, Socolow JS, Mao J, Hsiao, Broeze RJ. Spin filter perfusion system for high density cell culture: production of recombinat urinary type plasminogen activator in CHO cells. Nat Biotechnol. 1990; 8: 54-58.
37. 2 and/or osmolality on the growth and recombinant tPA production of CHO cells. Biotechnol Bioeng. 1996; 52: 152-160.
38. Pattison RN, Swamy J, Mendenhall B, Hwang B, Frohlich BT. Measurement and control of dissolved carbon dioxide in mammalian cell culture processes using an in situ fiber optic chemical sensor. Biotechnol Prog. 2000; 16: 769-774.
39. 2 stripping. Biotechnol J. 2011; 6: 1547-1556.
40. Huelscher M, Scheibler U, Onken U. Selective recycle of viable animal cells by coupling of airlift reactor and cell settler. Biotechnol Bioneng. 1992; 39: 442-446.
41. Hu WS, Piret JM. Mammalian cell culture processes. Curr Opin Biotechnol 1992; 3: 110-114.
42. Senger RS, Karim MN. Optimization of fed-batch parameters and harvest time of CHO cell cultures for a glycosylated product with multiple mechanisms of inactivation. Biotechnol Bioeng. 2007; 98: 378-390.
43. Jiang Z, Droms K, Geng Z, Casnocha S, Xiao Z, Gorfrien S, Jacobia SJ. Fed-batch cell culture process optimization-a rationally integrated approach. BioProcess Technical 2012; 10: 40-45.
44. Bibila TA, Robinson DK. In pursuit of the optimal fed batch process for monoclonal antibody production. Biotechnol Prog. 1995; 11: 1-13.
45. Roessler B, Luebben H, Kretzmer G. Temperature: a simple parameter for process optimization in fed-batch cultures of recombinant Chinese hamster ovary cells. Enzyme Microbial Technol. 1996; 18: 423-427.
46. Wong DCF, Wong DCF, Wong KTK, Goh LT, Heng CK, Yap MGS. Impact of dynamic online fed-batch strategies on metabolism, productivity and N-glycosylation quality in CHO cell cultures. Biotechnol Bioeng. 2005; 89: 164-177.
47. Lavric V, Ofiteru I, Woinaroschy A. A sensitivity analysis of the fed-batch animal-cell bioreactor with respect to some control parameters. Biotechnol Appl Biochem. 2005; 41: 29-35.
48. Whitford WG. Fed-batch mammalian cell culture in bioproduction. Bioprocess Int 2006; 4: 30-40.
49. Xie L, Zhou W. Fed-batch cultivation of mammalian cells for the production of recombinant proteins. In: Oztuk S, Hu W-S, editors. Cell Culture Technology for Pharmaceutical and Cellular Therapies. New York: Taylor and Francis; 2006: 349-416.