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Volumn 112, Issue 1, 2015, Pages 84-97

Application of bioreactor design principles and multivariate analysis for development of cell culture scale down models

Author keywords

Bioreactor design; Multivariate analysis; Process characterization; Quality by design; Scale down model; Scale up

Indexed keywords

BIOCONVERSION; BIOREACTORS; CELL CULTURE; CELLS; CYTOLOGY; DESIGN; MANUFACTURE; MASS TRANSFER; OXYGEN; QUALITY CONTROL; RECOMBINANT PROTEINS; VOLUMETRIC ANALYSIS;

EID: 84911408436     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.25330     Document Type: Article
Times cited : (40)

References (41)
  • 2
    • 77952051305 scopus 로고    scopus 로고
    • Designing in quality: Approaches to defining the design space for a monoclonal antibody process
    • Banerjee A. 2010. Designing in quality: Approaches to defining the design space for a monoclonal antibody process. BioPharm Int 23(5):26-40.
    • (2010) BioPharm Int , vol.23 , Issue.5 , pp. 26-40
    • Banerjee, A.1
  • 3
    • 0023725159 scopus 로고
    • Gas holdup in pneumatic reactors
    • Chisti MY, Moo-Young M. 1988. Gas holdup in pneumatic reactors. Chem Eng J 38(3):149-152.
    • (1988) Chem Eng J , vol.38 , Issue.3 , pp. 149-152
    • Chisti, M.Y.1    Moo-Young, M.2
  • 4
    • 0141756281 scopus 로고    scopus 로고
    • An integrated approach to optimization of Escherichia coli fermentations using historical data
    • Coleman MC, Buck KK, Block DE. 2003. An integrated approach to optimization of Escherichia coli fermentations using historical data. Biotechnol Bioeng 84(3):274-285.
    • (2003) Biotechnol Bioeng , vol.84 , Issue.3 , pp. 274-285
    • Coleman, M.C.1    Buck, K.K.2    Block, D.E.3
  • 5
    • 0032442233 scopus 로고    scopus 로고
    • 2 and osmolality on hybridoma cells: Growth, metabolism, and monoclonal antibody production
    • 2 and osmolality on hybridoma cells: Growth, metabolism, and monoclonal antibody production. Cytotechnology 28:213-227.
    • (1998) Cytotechnology , vol.28 , pp. 213-227
    • deZengotita, V.M.1    Kimura, R.2    Miller, W.M.3
  • 7
    • 84864776904 scopus 로고    scopus 로고
    • Development of a scaled-down aerobic fermentation model for scale-up in recombinant protein vaccine manufacturing
    • Farrell P, Sun J, Gao M, Sun H, Pattara B, Zeiser A, D'Amore T. 2012. Development of a scaled-down aerobic fermentation model for scale-up in recombinant protein vaccine manufacturing. Vaccine 30:5695-5698.
    • (2012) Vaccine , vol.30 , pp. 5695-5698
    • Farrell, P.1    Sun, J.2    Gao, M.3    Sun, H.4    Pattara, B.5    Zeiser, A.6    D'Amore, T.7
  • 8
    • 33745037702 scopus 로고    scopus 로고
    • A systematic approach for scale-down model development and characterization of commercial cell culture processes
    • Feng L, Hashimura Y, Pendleton R, Harms J, Collins E, Lee B. 2006. A systematic approach for scale-down model development and characterization of commercial cell culture processes. Biotechnol Prog 22(3):696-703.
    • (2006) Biotechnol Prog , vol.22 , Issue.3 , pp. 696-703
    • Feng, L.1    Hashimura, Y.2    Pendleton, R.3    Harms, J.4    Collins, E.5    Lee, B.6
  • 10
    • 34547874307 scopus 로고    scopus 로고
    • Fault detection and diagnosis in an industrial fed-batch cell culture process
    • Gunther JC, Conner JS, Seborg DE. 2007. Fault detection and diagnosis in an industrial fed-batch cell culture process. Biotechnol Prog 23(4):851-857.
    • (2007) Biotechnol Prog , vol.23 , Issue.4 , pp. 851-857
    • Gunther, J.C.1    Conner, J.S.2    Seborg, D.E.3
  • 11
    • 84893740303 scopus 로고    scopus 로고
    • Development and fine-tuning of a scale down model for process characterization studies of a monoclonal antibody upstream production process
    • Harmsen M, Stofferis J, Malphettes L. 2011. Development and fine-tuning of a scale down model for process characterization studies of a monoclonal antibody upstream production process. BMC Proc 5(Suppl 8):P70.
    • (2011) BMC Proc , vol.5 , pp. P70
    • Harmsen, M.1    Stofferis, J.2    Malphettes, L.3
  • 13
    • 84655167606 scopus 로고    scopus 로고
    • The potential of hydrodynamic damage to animal cells of industrial relevance: Current understanding
    • Hu W, Berdugo C, Chalmers JJ. 2011. The potential of hydrodynamic damage to animal cells of industrial relevance: Current understanding. Cytotechnology 63(5):445-460.
    • (2011) Cytotechnology , vol.63 , Issue.5 , pp. 445-460
    • Hu, W.1    Berdugo, C.2    Chalmers, J.J.3
  • 14
    • 79952202624 scopus 로고    scopus 로고
    • Maximizing productivity of CHO cell-based fed-batch culture using chemically defined media conditions and typical manufacturing equipment
    • Huang YH, Hu W, Rustandi E, Chang K, Yusuf-Makagiansar H, Ryll T. 2010. Maximizing productivity of CHO cell-based fed-batch culture using chemically defined media conditions and typical manufacturing equipment. Biotechnol Prog 26(5):1400-1410.
    • (2010) Biotechnol Prog , vol.26 , Issue.5 , pp. 1400-1410
    • Huang, Y.H.1    Hu, W.2    Rustandi, E.3    Chang, K.4    Yusuf-Makagiansar, H.5    Ryll, T.6
  • 15
    • 84911385992 scopus 로고    scopus 로고
    • Q9 Quality risk management; Geneva, Switzerland
    • International Conference on Harmonization. Q9 Quality risk management; Geneva, Switzerland, 2006.
    • (2006)
  • 16
    • 0026416587 scopus 로고
    • Lethal events during gas sparging in animal cell culture
    • Jobses I, Martens D, Tramper J. 1991. Lethal events during gas sparging in animal cell culture. Biotechnol Bioeng 37(5):484-490.
    • (1991) Biotechnol Bioeng , vol.37 , Issue.5 , pp. 484-490
    • Jobses, I.1    Martens, D.2    Tramper, J.3
  • 17
    • 0026440937 scopus 로고
    • Improved scale-up strategies of bioreactors
    • Ju LK, Chase GG. 1992. Improved scale-up strategies of bioreactors. Bioprocess Eng 8(1-2):49-53.
    • (1992) Bioprocess Eng , vol.8 , Issue.1-2 , pp. 49-53
    • Ju, L.K.1    Chase, G.G.2
  • 18
    • 33847173754 scopus 로고    scopus 로고
    • Application of multivariate analysis toward biotech processes: Case study of a cell culture unit operation
    • Kirdar AO, Conner JS, Baclaski J, Rathore AS. 2007. Application of multivariate analysis toward biotech processes: Case study of a cell culture unit operation. Biotechnol Prog 23(1):61-67.
    • (2007) Biotechnol Prog , vol.23 , Issue.1 , pp. 61-67
    • Kirdar, A.O.1    Conner, J.S.2    Baclaski, J.3    Rathore, A.S.4
  • 19
    • 45149094660 scopus 로고    scopus 로고
    • Application of multivariate data analysis for identification and successful resolution of a root cause for a bioprocessing application
    • Kirdar AO, Green KD, Rathore AS. 2008. Application of multivariate data analysis for identification and successful resolution of a root cause for a bioprocessing application. Biotechnol Prog 24(3):720-726.
    • (2008) Biotechnol Prog , vol.24 , Issue.3 , pp. 720-726
    • Kirdar, A.O.1    Green, K.D.2    Rathore, A.S.3
  • 20
    • 33845391516 scopus 로고    scopus 로고
    • Process analytical technology beyond real-time analyzers: The role of multivariate analysis
    • Kourti T. 2006. Process analytical technology beyond real-time analyzers: The role of multivariate analysis. Crit Rev Anal Chem 36(3-4):257-278.
    • (2006) Crit Rev Anal Chem , vol.36 , Issue.3-4 , pp. 257-278
    • Kourti, T.1
  • 21
    • 84868481008 scopus 로고    scopus 로고
    • Multivariate analysis of cell culture bioprocess data-Lactate consumption as process indicator
    • Le H, Kabbur S, Pollastrini L, Sun Z, Mills K, Johnson K, Karypis G, Hu W. 2012. Multivariate analysis of cell culture bioprocess data-Lactate consumption as process indicator. J Biotechnol 162(2-3):210-223.
    • (2012) J Biotechnol , vol.162 , Issue.2-3 , pp. 210-223
    • Le, H.1    Kabbur, S.2    Pollastrini, L.3    Sun, Z.4    Mills, K.5    Johnson, K.6    Karypis, G.7    Hu, W.8
  • 22
    • 0026656093 scopus 로고
    • Advanced methods for bioreactor characterization
    • Luebbert A. 1992. Advanced methods for bioreactor characterization. J Biotechnol 25(1-2):145-182.
    • (1992) J Biotechnol , vol.25 , Issue.1-2 , pp. 145-182
    • Luebbert, A.1
  • 23
    • 4043130854 scopus 로고    scopus 로고
    • Quantitative studies of cell-bubble interactions and cell damage at different Pluronic F-68 and cell concentrations
    • Ma N, Chalmers JJ, Aunins G, Zhou W, Xie L. 2004. Quantitative studies of cell-bubble interactions and cell damage at different Pluronic F-68 and cell concentrations. Biotechnol Prog 20(4):1183-1191.
    • (2004) Biotechnol Prog , vol.20 , Issue.4 , pp. 1183-1191
    • Ma, N.1    Chalmers, J.J.2    Aunins, G.3    Zhou, W.4    Xie, L.5
  • 24
    • 0033585825 scopus 로고    scopus 로고
    • Cell death from bursting bubbles: Role of cell attachment to rising bubbles in sparged reactors
    • Meier SJ, Hatton TA, Wang DIC. 1999. Cell death from bursting bubbles: Role of cell attachment to rising bubbles in sparged reactors. Biotechnol Bioeng 62(4):469-478.
    • (1999) Biotechnol Bioeng , vol.62 , Issue.4 , pp. 469-478
    • Meier, S.J.1    Hatton, T.A.2    Wang, D.I.C.3
  • 25
    • 0037279448 scopus 로고    scopus 로고
    • 2 removal in large-scale fed-batch cultures
    • 2 removal in large-scale fed-batch cultures. Biotechnol Prog 19:45-51.
    • (2003) Biotechnol Prog , vol.19 , pp. 45-51
    • Mostafa, S.S.1    Gu, X.2
  • 26
    • 0025397851 scopus 로고
    • Structural features of nonionic polyglycol polymer molecules responsible for the protective effect in sparged animal cell bioreactors
    • Murhammer DW, Goochee CF. 1990. Structural features of nonionic polyglycol polymer molecules responsible for the protective effect in sparged animal cell bioreactors. Biotechnol Prog 6(2):142-148.
    • (1990) Biotechnol Prog , vol.6 , Issue.2 , pp. 142-148
    • Murhammer, D.W.1    Goochee, C.F.2
  • 27
    • 33747343749 scopus 로고    scopus 로고
    • Reactor engineering in large scale animal cell culture
    • Nienow AW. 2006. Reactor engineering in large scale animal cell culture. Cytotechnology 50(1-3):9-33.
    • (2006) Cytotechnology , vol.50 , Issue.1-3 , pp. 9-33
    • Nienow, A.W.1
  • 28
    • 0030440688 scopus 로고    scopus 로고
    • Engineering challenges in high density cell culture systems
    • Ozturk SS. 1996. Engineering challenges in high density cell culture systems. Cytotechnology 22:3-16.
    • (1996) Cytotechnology , vol.22 , pp. 3-16
    • Ozturk, S.S.1
  • 29
    • 84893737333 scopus 로고    scopus 로고
    • Leveraging multivariate analysis tools to qualify scaled-down models
    • In: Rathore AS, Sofer G, editors., 3rd edn. Boca Raton: CRC Press. p -.
    • Pieracci J, Yusuf-Makagiansar H. 2012. Leveraging multivariate analysis tools to qualify scaled-down models. In: Rathore AS, Sofer G, editors. Process validation in manufacturing of biopharmaceuticals, 3rd edn. Boca Raton: CRC Press. p 411-440.
    • (2012) Process validation in manufacturing of biopharmaceuticals , pp. 411-440
    • Pieracci, J.1    Yusuf-Makagiansar, H.2
  • 30
    • 15244342436 scopus 로고    scopus 로고
    • Scaling down of biopharmaceutical unit operations-Part I: Fermentation
    • 64
    • Rathore A, Krishnan R, Tozer S, Smiley D, Rausch S, Seely J. Scaling down of biopharmaceutical unit operations-Part I: Fermentation. BioPharm Int 2005. 60(62): 64, 67-68.
    • (2005) BioPharm Int , vol.60 , Issue.62 , pp. 67-68
    • Rathore, A.1    Krishnan, R.2    Tozer, S.3    Smiley, D.4    Rausch, S.5    Seely, J.6
  • 31
    • 60149106150 scopus 로고    scopus 로고
    • Quality by design for biopharmaceuticals
    • Rathore AS, Winkle H. 2009. Quality by design for biopharmaceuticals. Nat Biotechnol 27(1):26-34.
    • (2009) Nat Biotechnol , vol.27 , Issue.1 , pp. 26-34
    • Rathore, A.S.1    Winkle, H.2
  • 32
    • 77957362549 scopus 로고    scopus 로고
    • Combined data preprocessing and multivariate statistical analysis characterizes fed-batch culture of mouse hybridoma cells for rational medium design
    • Selvarasu S, Kim DY, Karimi IA, Lee D. 2010. Combined data preprocessing and multivariate statistical analysis characterizes fed-batch culture of mouse hybridoma cells for rational medium design. J Biotechnol 150(1):94-100.
    • (2010) J Biotechnol , vol.150 , Issue.1 , pp. 94-100
    • Selvarasu, S.1    Kim, D.Y.2    Karimi, I.A.3    Lee, D.4
  • 33
    • 77955411444 scopus 로고    scopus 로고
    • Practical considerations for DOE implementation in quality by design
    • Shivhare M, McCreath G. 2010. Practical considerations for DOE implementation in quality by design. BioProcess Int 8(6):22-30.
    • (2010) BioProcess Int , vol.8 , Issue.6 , pp. 22-30
    • Shivhare, M.1    McCreath, G.2
  • 34
    • 77956245938 scopus 로고    scopus 로고
    • Multivariate data analysis on historical IPV production data for better process understanding and future improvements
    • Thomassen YE, van Sprang ENM, van der Pol LA, Bakker WAM. 2010. Multivariate data analysis on historical IPV production data for better process understanding and future improvements. Biotechnol Bioeng 107(1):96-104.
    • (2010) Biotechnol Bioeng , vol.107 , Issue.1 , pp. 96-104
    • Thomassen, Y.E.1    van Sprang, E.N.M.2    van der Pol, L.A.3    Bakker, W.A.M.4
  • 35
    • 84893794827 scopus 로고    scopus 로고
    • Development of a scale down cell culture model using multivariate analysis as a qualification tool
    • Online early access]. Published Online: October 22, 2013. (accessed October 22, 2013).
    • Tsang V, Wang A, Yusuf-Makagiansar H, Ryll T. 2013. Development of a scale down cell culture model using multivariate analysis as a qualification tool. Biotechnol Prog [Online early access]. doi: 10.1002/btpr.1819. Published Online: October 22, 2013. http://onlinelibrary.wiley.com/doi/10.1002/btpr.1819/pdf (accessed October 22, 2013).
    • (2013) Biotechnol Prog
    • Tsang, V.1    Wang, A.2    Yusuf-Makagiansar, H.3    Ryll, T.4
  • 36
    • 34247541917 scopus 로고    scopus 로고
    • Rockville, MD: US Department of Health and Human Services.
    • US Food and Drug Administration. 2006. Guidance for industry: Q9 Quality risk management. Rockville, MD: US Department of Health and Human Services.
    • (2006) Guidance for industry: Q9 Quality risk management
  • 37
    • 0018491753 scopus 로고
    • Review of measuring methods and results in nonviscous gas-liquid mass transfer in stirred vessels
    • Van't Riet K. 1979. Review of measuring methods and results in nonviscous gas-liquid mass transfer in stirred vessels. Ind Eng Chem Process Des Dev 18(3):357-364.
    • (1979) Ind Eng Chem Process Des Dev , vol.18 , Issue.3 , pp. 357-364
    • Van't Riet, K.1
  • 38
    • 67650188204 scopus 로고    scopus 로고
    • Scale-up analysis for a CHO cell culture process in large-scale bioreactors
    • Xing Z, Kenty BM, Li ZJ, Lee SS. 2009. Scale-up analysis for a CHO cell culture process in large-scale bioreactors. Biotechnol Bioeng 103(4):733-746.
    • (2009) Biotechnol Bioeng , vol.103 , Issue.4 , pp. 733-746
    • Xing, Z.1    Kenty, B.M.2    Li, Z.J.3    Lee, S.S.4
  • 40
    • 77950143374 scopus 로고    scopus 로고
    • Engineering considerations for process development in mammalian cell cultivation
    • Zhang H, Wang W, Quan C, Fan S. 2010. Engineering considerations for process development in mammalian cell cultivation. Curr Pharm Biotechnol 11(1):103-112.
    • (2010) Curr Pharm Biotechnol , vol.11 , Issue.1 , pp. 103-112
    • Zhang, H.1    Wang, W.2    Quan, C.3    Fan, S.4
  • 41
    • 55549108737 scopus 로고    scopus 로고
    • NS0 cell damage by high gas velocity sparging in protein-free and cholesterol-free cultures
    • Zhu Y, Cuenca JV, Zhou W, Varma A. 2008. NS0 cell damage by high gas velocity sparging in protein-free and cholesterol-free cultures. Biotechnol Bioeng 101(4):751-760.
    • (2008) Biotechnol Bioeng , vol.101 , Issue.4 , pp. 751-760
    • Zhu, Y.1    Cuenca, J.V.2    Zhou, W.3    Varma, A.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.