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Volumn 31, Issue 3, 2013, Pages 147-154

Single-use disposable technologies for biopharmaceutical manufacturing

Author keywords

[No Author keywords available]

Indexed keywords

CURRENT GOOD MANUFACTURING PRACTICES; DISPOSABLE TECHNOLOGY; DOWNSTREAM PURIFICATIONS; IMPROVE PERFORMANCE; MANUFACTURING FACILITY; MANUFACTURING PROCESS; PRODUCTION FACILITY; TECHNICAL ADVANCES;

EID: 84875253542     PISSN: 01677799     EISSN: 18793096     Source Type: Journal    
DOI: 10.1016/j.tibtech.2012.10.004     Document Type: Review
Times cited : (200)

References (43)
  • 4
    • 74949097431 scopus 로고    scopus 로고
    • Disposables in downstream processing
    • Springer, R. Eibl, D. Eibl (Eds.) Disposable Bioreactors
    • Gottschalk U. Disposables in downstream processing. Advances in Biochemical Engineering/Biotechnology 2010, Vol. 115:171-183. Springer. R. Eibl, D. Eibl (Eds.).
    • (2010) Advances in Biochemical Engineering/Biotechnology , vol.115 , pp. 171-183
    • Gottschalk, U.1
  • 5
    • 77951649247 scopus 로고    scopus 로고
    • The impact of disposables on project economics in a new antibody plant: a case study
    • Pais-Chanfrau J., et al. The impact of disposables on project economics in a new antibody plant: a case study. BioPharm. Int. 2009, 22:62-74.
    • (2009) BioPharm. Int. , vol.22 , pp. 62-74
    • Pais-Chanfrau, J.1
  • 6
    • 77953450970 scopus 로고    scopus 로고
    • 9th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
    • A Study of Biotherapeutic Developers and Contract Manufacturing Organizations, BioPlan Associates
    • Langer, E.S. (2012) 9th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. A Study of Biotherapeutic Developers and Contract Manufacturing Organizations, BioPlan Associates.
    • (2012)
    • Langer, E.S.1
  • 7
    • 77956690413 scopus 로고    scopus 로고
    • Biopharmaceutical benchmarks 2010
    • Walsh G. Biopharmaceutical benchmarks 2010. Nat. Biotechnol. 2010, 28:917-924.
    • (2010) Nat. Biotechnol. , vol.28 , pp. 917-924
    • Walsh, G.1
  • 8
    • 2442590862 scopus 로고    scopus 로고
    • New drugs for rheumatoid arthritis
    • Olsen N., Stein M. New drugs for rheumatoid arthritis. N. Engl. J. Med. 2004, 350:2167-2179.
    • (2004) N. Engl. J. Med. , vol.350 , pp. 2167-2179
    • Olsen, N.1    Stein, M.2
  • 9
    • 70449348153 scopus 로고    scopus 로고
    • Follow-on protein products: scientific issues, development and challenges
    • Rathore A. Follow-on protein products: scientific issues, development and challenges. Trends Biotechnol. 2009, 27:698-705.
    • (2009) Trends Biotechnol. , vol.27 , pp. 698-705
    • Rathore, A.1
  • 10
    • 84862008938 scopus 로고    scopus 로고
    • The need for innovation in biomanufacturing
    • Gottschalk U., et al. The need for innovation in biomanufacturing. Nat. Biotechnol. 2012, 30:489-492.
    • (2012) Nat. Biotechnol. , vol.30 , pp. 489-492
    • Gottschalk, U.1
  • 11
    • 77953655955 scopus 로고    scopus 로고
    • Industrialization of mAb production technology
    • Kelley B. Industrialization of mAb production technology. Monocl. Antibod. 2009, 1:443-452.
    • (2009) Monocl. Antibod. , vol.1 , pp. 443-452
    • Kelley, B.1
  • 12
    • 0032924570 scopus 로고    scopus 로고
    • Disposable bioreactor for cell culture using wave induced agitation
    • Singh V. Disposable bioreactor for cell culture using wave induced agitation. Cytotechnology 1999, 30:149-158.
    • (1999) Cytotechnology , vol.30 , pp. 149-158
    • Singh, V.1
  • 13
    • 33845936631 scopus 로고    scopus 로고
    • Serum-free suspension large-scale transient transfection of CHO cells in WAVE bioreactors
    • Haldankar R., et al. Serum-free suspension large-scale transient transfection of CHO cells in WAVE bioreactors. Mol. Biotechnol. 2006, 34:191-199.
    • (2006) Mol. Biotechnol. , vol.34 , pp. 191-199
    • Haldankar, R.1
  • 14
    • 1042264084 scopus 로고    scopus 로고
    • TubeSpin satellites: a fast track approach for process development with animal cells using shaking technology
    • De Jesusa M.J., et al. TubeSpin satellites: a fast track approach for process development with animal cells using shaking technology. Biochem. Eng. J. 2004, 17:217-223.
    • (2004) Biochem. Eng. J. , vol.17 , pp. 217-223
    • De Jesusa, M.J.1
  • 15
    • 13544257263 scopus 로고    scopus 로고
    • Transient gene expression in suspension HEK-293 cells: application to large-scale protein production
    • Baldi L., et al. Transient gene expression in suspension HEK-293 cells: application to large-scale protein production. Biotechnol. Prog. 2005, 21:148-153.
    • (2005) Biotechnol. Prog. , vol.21 , pp. 148-153
    • Baldi, L.1
  • 16
    • 33748996938 scopus 로고    scopus 로고
    • New disposable tubes for rapid and precise biomass assessment for suspension cultures of mammalian cells
    • Stettler M., et al. New disposable tubes for rapid and precise biomass assessment for suspension cultures of mammalian cells. Biotechnol. Bioeng. 2006, 95:1228-1233.
    • (2006) Biotechnol. Bioeng. , vol.95 , pp. 1228-1233
    • Stettler, M.1
  • 17
    • 34147112902 scopus 로고    scopus 로고
    • Scalable transient gene expression in Chinese hamster ovary cells in instrumented and noninstrumented cultivation systems
    • Muller N., et al. Scalable transient gene expression in Chinese hamster ovary cells in instrumented and noninstrumented cultivation systems. Biotechnol. Lett. 2007, 29:703-711.
    • (2007) Biotechnol. Lett. , vol.29 , pp. 703-711
    • Muller, N.1
  • 18
    • 44849102747 scopus 로고    scopus 로고
    • Harvest and recovery of monoclonal antibodies from large-scale mammalian cell culture
    • Shukla A., Kandula J. Harvest and recovery of monoclonal antibodies from large-scale mammalian cell culture. BioPharm. Int. 2008, 21:34-45.
    • (2008) BioPharm. Int. , vol.21 , pp. 34-45
    • Shukla, A.1    Kandula, J.2
  • 19
    • 0035313212 scopus 로고    scopus 로고
    • Membrane separations in biotechnology
    • Van Reis R., Zydney A. Membrane separations in biotechnology. Curr. Opin. Biotechnol. 2001, 12:208-211.
    • (2001) Curr. Opin. Biotechnol. , vol.12 , pp. 208-211
    • Van Reis, R.1    Zydney, A.2
  • 20
    • 84863481238 scopus 로고    scopus 로고
    • Vertical Integration of disposables in biopharmaceutical drug substance manufacturing
    • Shukla A., et al. Vertical Integration of disposables in biopharmaceutical drug substance manufacturing. Bioprocess Int. 2012, 10:34-47.
    • (2012) Bioprocess Int. , vol.10 , pp. 34-47
    • Shukla, A.1
  • 21
    • 77953414280 scopus 로고    scopus 로고
    • Introducing disposable systems into biomanufacturing - a CMO case study
    • Fuller M., Pora H. Introducing disposable systems into biomanufacturing - a CMO case study. Bioprocess Int. 2008, 6:30-36.
    • (2008) Bioprocess Int. , vol.6 , pp. 30-36
    • Fuller, M.1    Pora, H.2
  • 22
    • 77956253459 scopus 로고    scopus 로고
    • A fully disposable monoclonal antibody manufacturing train
    • Wilson J. A fully disposable monoclonal antibody manufacturing train. Bioprocess Int. 2006, 4:34-36.
    • (2006) Bioprocess Int. , vol.4 , pp. 34-36
    • Wilson, J.1
  • 23
    • 77951979046 scopus 로고    scopus 로고
    • Advances in large-scale production of monoclonal antibodies and related proteins
    • Shukla A., Thommes J. Advances in large-scale production of monoclonal antibodies and related proteins. Trends Biotechnol. 2010, 28:253-261.
    • (2010) Trends Biotechnol. , vol.28 , pp. 253-261
    • Shukla, A.1    Thommes, J.2
  • 25
    • 15244355050 scopus 로고    scopus 로고
    • New and unknown challenges facing biomanufacturing
    • Gottschalk U. New and unknown challenges facing biomanufacturing. BioPharm. Int. 2005, 18:24-28.
    • (2005) BioPharm. Int. , vol.18 , pp. 24-28
    • Gottschalk, U.1
  • 26
    • 33744983118 scopus 로고    scopus 로고
    • The Renaissance of protein purification
    • Gottschalk U. The Renaissance of protein purification. BioPharm. Int. 2006, 19:8-9.
    • (2006) BioPharm. Int. , vol.19 , pp. 8-9
    • Gottschalk, U.1
  • 27
    • 33947581496 scopus 로고    scopus 로고
    • Quantitation of interaction of lipids with polymer surfaces in cell culture
    • Altaras G., et al. Quantitation of interaction of lipids with polymer surfaces in cell culture. Biotechnol. Bioeng. 2007, 96:999-1007.
    • (2007) Biotechnol. Bioeng. , vol.96 , pp. 999-1007
    • Altaras, G.1
  • 28
    • 33846870604 scopus 로고    scopus 로고
    • Cholesterol delivery to NS0 cells: challenges and solutions in disposable linear low-density polyethylene-based bioreactors
    • Okonkowski J., et al. Cholesterol delivery to NS0 cells: challenges and solutions in disposable linear low-density polyethylene-based bioreactors. J. Biosci. Bioeng. 2007, 103:50-59.
    • (2007) J. Biosci. Bioeng. , vol.103 , pp. 50-59
    • Okonkowski, J.1
  • 29
    • 84864377622 scopus 로고    scopus 로고
    • Novel cholesterol feeding strategy enables cultivation of NS0 cells in low-density polyethylene-based bioreactors
    • Tao Y., et al. Novel cholesterol feeding strategy enables cultivation of NS0 cells in low-density polyethylene-based bioreactors. Biotechnol. Lett. 2012, 34:1453-1458.
    • (2012) Biotechnol. Lett. , vol.34 , pp. 1453-1458
    • Tao, Y.1
  • 32
    • 33644663961 scopus 로고    scopus 로고
    • Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative
    • Hinz D.C. Process analytical technologies in the pharmaceutical industry: the FDA's PAT initiative. Anal. Bioanal. Chem. 2006, 384:1036-1042.
    • (2006) Anal. Bioanal. Chem. , vol.384 , pp. 1036-1042
    • Hinz, D.C.1
  • 33
    • 43349088601 scopus 로고    scopus 로고
    • Pharmaceutical quality by design: product and process development, understanding, and control
    • Yu L.X. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm. Res. 2008, 25:781-791.
    • (2008) Pharm. Res. , vol.25 , pp. 781-791
    • Yu, L.X.1
  • 34
    • 84875254393 scopus 로고    scopus 로고
    • FDA, Final Report on Pharmaceutical cGMPs for the 21st Century - a Risk-based Approach, FDA
    • FDA (2003) Final Report on Pharmaceutical cGMPs for the 21st Century - a Risk-based Approach, FDA.
    • (2003)
  • 35
    • 80052185259 scopus 로고    scopus 로고
    • Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes
    • De Beer T., et al. Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. Int. J. Pharm. 2011, 417:32-47.
    • (2011) Int. J. Pharm. , vol.417 , pp. 32-47
    • De Beer, T.1
  • 36
    • 78649410389 scopus 로고    scopus 로고
    • Improved Process Analytical Technology (PAT) for Protein A chromatography using predictive PCA tools
    • Hou Y., et al. Improved Process Analytical Technology (PAT) for Protein A chromatography using predictive PCA tools. Biotechnol. Bioeng. 2011, 108:59-68.
    • (2011) Biotechnol. Bioeng. , vol.108 , pp. 59-68
    • Hou, Y.1
  • 37
    • 84862126576 scopus 로고    scopus 로고
    • Rapid evaluation for heterogeneities in monoclonal antibodies by liquid chromatography/mass spectrometry with a column-switching system
    • Kuribayashi R., et al. Rapid evaluation for heterogeneities in monoclonal antibodies by liquid chromatography/mass spectrometry with a column-switching system. J. Pharm. Biomed. Anal. 2012, 67-68:1-9.
    • (2012) J. Pharm. Biomed. Anal. , pp. 1-9
    • Kuribayashi, R.1
  • 38
    • 84857560234 scopus 로고    scopus 로고
    • Single-use equipment in biopharmaceutical manufacture: a brief introduction
    • John Wiley & Sons, R. Eibl, D. Eibl (Eds.)
    • Eibl D., et al. Single-use equipment in biopharmaceutical manufacture: a brief introduction. Single-use Technology in Biopharmaceutical Manufacture 2011, 1-11. John Wiley & Sons. R. Eibl, D. Eibl (Eds.).
    • (2011) Single-use Technology in Biopharmaceutical Manufacture , pp. 1-11
    • Eibl, D.1
  • 39
    • 79957617897 scopus 로고    scopus 로고
    • How multi-purpose is a single-use bioreactor?
    • Oosterhuis N., van den Berg H. How multi-purpose is a single-use bioreactor?. Biopharm. Int. 2011, 24:51-56.
    • (2011) Biopharm. Int. , vol.24 , pp. 51-56
    • Oosterhuis, N.1    van den Berg, H.2
  • 40
    • 14244252530 scopus 로고    scopus 로고
    • Orbital shaker technology for the cultivation of mammalian cells in suspension
    • Muller N., et al. Orbital shaker technology for the cultivation of mammalian cells in suspension. Biotechnol. Bioeng. 2004, 89:400-406.
    • (2004) Biotechnol. Bioeng. , vol.89 , pp. 400-406
    • Muller, N.1
  • 41
    • 79958043751 scopus 로고    scopus 로고
    • Efficient and reproducible mammalian cell bioprocesses without probes and controllers?
    • Tissot S., et al. Efficient and reproducible mammalian cell bioprocesses without probes and controllers?. N. Biotechnol. 2011, 28:382-390.
    • (2011) N. Biotechnol. , vol.28 , pp. 382-390
    • Tissot, S.1
  • 42
    • 84875245976 scopus 로고    scopus 로고
    • Characterization of novel pneumatic mixing for single-use bioreactor application
    • Lee B., et al. Characterization of novel pneumatic mixing for single-use bioreactor application. BMC Proc. 2011, 5:1-2.
    • (2011) BMC Proc. , vol.5 , pp. 1-2
    • Lee, B.1
  • 43
    • 80053542109 scopus 로고    scopus 로고
    • Performance of high intensity mammalian fed batch cell cultures in disposable bioreactors
    • Smelko J., et al. Performance of high intensity mammalian fed batch cell cultures in disposable bioreactors. Biotechnol. Prog. 2011, 27:1358-1364.
    • (2011) Biotechnol. Prog. , vol.27 , pp. 1358-1364
    • Smelko, J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.