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Volumn , Issue , 2013, Pages 487-526

Bright Future Outlook and Huge Challenges to Overcome: An Attempt to Write the Short Story of the Biopharma Industry with Current Status, Selected Issues, and Potential Solutions in Discovery, R&D, and Manufacturing

Author keywords

Biomarker; Biopharma industry; Biopharmaceutical; Chromatography, downstream processing; Engineering firm; Manufacturing cost; Process development; Process integration; QbD; R D cost; Sourcing; Upstream processing

Indexed keywords


EID: 84885497662     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9783527669417.ch22     Document Type: Chapter
Times cited : (4)

References (50)
  • 1
    • 34548324706 scopus 로고    scopus 로고
    • The cost of biopharmaceutical R&D: is biotech different? Manage
    • DiMasi, J.A. and Grabowski, H.G. (2007) The cost of biopharmaceutical R&D: is biotech different? Manage. Decis. Econ., 28, 469-479.
    • (2007) Decis. Econ. , vol.28 , pp. 469-479
    • DiMasi, J.A.1    Grabowski, H.G.2
  • 2
    • 84885531110 scopus 로고    scopus 로고
    • Harris Interactive: poll conducted online by between April 30 and May 14 2008
    • [2008(] Harris Interactive: poll conducted online by between April 30 and May 14 2008, published by International Herald Tribune, May
    • (2008) published by International Herald Tribune, May
  • 4
    • 84889966052 scopus 로고    scopus 로고
    • Current status of modern biopharmaceuticals: Approved products and trends in approvals, in Modern Biopharmaceuticals
    • Walsh, G. (2005) Current status of modern biopharmaceuticals: Approved products and trends in approvals, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 1 (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1-34.
    • (2005) Design, Development and Optimization 1ed.J.KnableinWiley-VCHVerlagGmbH , pp. 1-34
    • Walsh, G.1
  • 5
    • 84889979454 scopus 로고    scopus 로고
    • Manufacture of recombinant Biopharmaceuticals, in Modern Biopharmaceuticals
    • part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Wurm, F. (2005) Manufacture of recombinant Biopharmaceuticals, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 723-759.
    • (2005) Design, Development and Optimization , vol.3 , pp. 723-759
    • Wurm, F.1
  • 6
    • 84889998891 scopus 로고    scopus 로고
    • Advanced expression of biopharmaceuticals at industrial scale: the insulin success story, in Modern Biopharmaceuticals
    • part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Andersen, A.S. and Diers, I. (2005) Advanced expression of biopharmaceuticals at industrial scale: the insulin success story, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1033-1042.
    • (2005) Design, Development and Optimization , vol.3 , pp. 1033-1042
    • Andersen, A.S.1    Diers, I.2
  • 7
    • 84885548343 scopus 로고    scopus 로고
    • Healthcare trends and their impact on the biopharmaceutical industry: biopharmaceuticals come of age, in Modern Biopharmaceuticals
    • part VIII (ed. J. Knablein), Wiley-VCH Verlag GmbH, p
    • Moscho, A., Schafer, M. A., and Yarema, K. (2005) Healthcare trends and their impact on the biopharmaceutical industry: biopharmaceuticals come of age, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VIII (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1711-1739.
    • (2005) Design, Development and Optimization , vol.4 , pp. 1711-1739
    • Moscho, A.1    Schafer, M.A.2    Yarema, K.3
  • 8
    • 84889960726 scopus 로고    scopus 로고
    • The development of Herceptin1: paving the way for individualized cancer therapy, in Modern Biopharmaceuticals
    • part I (ed. J. Knablein), Wiley-VCH Verlag GmbH, p
    • Gutjahr, T. (2005) The development of Herceptin1: paving the way for individualized cancer therapy, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 1, part I (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 127-149.
    • (2005) Design, Development and Optimization , vol.1 , pp. 127-149
    • Gutjahr, T.1
  • 9
    • 84890004131 scopus 로고    scopus 로고
    • Contract manufacturing of biopharmaceuticals including antibodies or antibody fragments, in Modern Biopharmaceuticals
    • part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Hempel, J.C. et al. (2005) Contract manufacturing of biopharmaceuticals including antibodies or antibody fragments, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1083-1142.
    • (2005) Design, Development and Optimization , vol.3 , pp. 1083-1142
    • Hempel, J.C.1
  • 10
    • 84890004632 scopus 로고    scopus 로고
    • Modern antibody technology: the impact on drug development, in Modern Biopharmaceuticals
    • part V (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Moroney, S. and Pluckthun, A. (2005) Modern antibody technology: the impact on drug development, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part V (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1147-1186.
    • (2005) Design, Development and Optimization , vol.3 , pp. 1147-1186
    • Moroney, S.1    Pluckthun, A.2
  • 11
    • 84889995203 scopus 로고    scopus 로고
    • Thirty years of monoclonal antibodies: a long way to pharmaceutical and commercial success, in Modern Biopharmaceuticals
    • part V (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Gottschalk, U. and Mundt, K. (2005) Thirty years of monoclonal antibodies: a long way to pharmaceutical and commercial success, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part V (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1105-1145.
    • (2005) Design, Development and Optimization , vol.3 , pp. 1105-1145
    • Gottschalk, U.1    Mundt, K.2
  • 12
    • 84885534597 scopus 로고    scopus 로고
    • AIDS gene therapy: a vector selectively able to destroy latently HIV-1-infectedCells, in Modern Biopharmaceuticals
    • part II (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • V́azquez, F.L. and Oya, R. (2005) AIDS gene therapy: a vector selectively able to destroy latently HIV-1-infectedCells, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 2, part II (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 549-559.
    • (2005) Design, Development and Optimization , vol.2 , pp. 549-559
    • Vázquez, F.L.1    Oya, R.2
  • 13
    • 84889983969 scopus 로고    scopus 로고
    • Rational siRNA design for RNA interference: optimization for therapeutic use, in Modern Biopharmaceuticals
    • part I (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Boese, Q. and Khvorova, A., (2005) Rational siRNA design for RNA interference: optimization for therapeutic use, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 1, part I (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 243-264.
    • (2005) Design, Development and Optimization , vol.1 , pp. 243-264
    • Boese, Q.1    Khvorova, A.2
  • 14
    • 84889964545 scopus 로고    scopus 로고
    • Combinatorial RNA-based Therapies for HIV-1, in Modern Biopharmaceuticals
    • part II (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Morris, K.V. and Rossi, J.J. (2005) Combinatorial RNA-based Therapies for HIV-1, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 2, part II (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 569-577.
    • (2005) Design, Development and Optimization , vol.2 , pp. 569-577
    • Morris, K.V.1    Rossi, J.J.2
  • 15
    • 34247170389 scopus 로고    scopus 로고
    • Programmed packaging: a new drug delivery system and its application to Gene therapy, in Modern Biopharmaceuticals
    • part VI (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Kogure, K., Akita, H., Kamiya, H., and Harashima, H. (2005) Programmed packaging: a new drug delivery system and its application to Gene therapy, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VI (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1521-1534.
    • (2005) Design, Development and Optimization , vol.4 , pp. 1521-1534
    • Kogure, K.1    Akita, H.2    Kamiya, H.3    Harashima, H.4
  • 16
    • 84889954515 scopus 로고    scopus 로고
    • Novel vaccine adjuvants based on cationic peptide delivery systems, in Modern Biopharmaceuticals
    • part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Lingnau, K., Klade, C., Buschle, M., and von Gabain, A. (2005) Novel vaccine adjuvants based on cationic peptide delivery systems, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1419- 1440.
    • (2005) Design, Development and Optimization , vol.4 , pp. 1419-1440
    • Lingnau, K.1    Klade, C.2    Buschle, M.3    von Gabain, A.4
  • 17
    • 84889986358 scopus 로고    scopus 로고
    • Ligand-based targeting of disease: From antibodies to small organic (synthetic) ligands, in Modern Biopharmaceuticals
    • part V (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Silacci, M. and Neri, D. (2005) Ligand-based targeting of disease: From antibodies to small organic (synthetic) ligands, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part V (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1271-1289.
    • (2005) Design, Development and Optimization , vol.3 , pp. 1271-1289
    • Silacci, M.1    Neri, D.2
  • 18
    • 84889958217 scopus 로고    scopus 로고
    • Spheramine1: a cell therapeutic approach to Parkinson's disease, in Modern Biopharmaceuticals
    • part I (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Reissig, E., Graf, H., and Kapp, F.-J., (2005) Spheramine1: a cell therapeutic approach to Parkinson's disease, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 1, part I (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 325-348.
    • (2005) Design, Development and Optimization , vol.1 , pp. 325-348
    • Reissig, E.1    Graf, H.2    Kapp, F.J.3
  • 19
    • 84885543977 scopus 로고    scopus 로고
    • The evolving role of oral spray insulin in the treatment of diabetes, in Modern Biopharmaceuticals
    • part VI (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Modi, P., (2005) The evolving role of oral spray insulin in the treatment of diabetes, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VI (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1445-1460.
    • (2005) Design, Development and Optimization , vol.4 , pp. 1445-1460
    • Modi, P.1
  • 21
    • 84885556808 scopus 로고    scopus 로고
    • Chapter 8 Process Economy in Handbook of Process Chromatography
    • Hagel, L., Jagschies, G., and Sofer, G. (2007) Chapter 8: Process Economy in Handbook of Process Chromatography, 2nd edn, Elsevier Academic Press, pp. 189-218.
    • (2007) 2nd edn, Elsevier Academic Press , pp. 189-218
    • Hagel, L.1    Jagschies, G.2    Sofer, G.3
  • 23
    • 84885518037 scopus 로고    scopus 로고
    • IBM Global Business Services Pharma The Threshold of Innovation, Somers, NY
    • 2004 from (accessed 27 December, 2012)
    • IBM Global Business Services Pharma 2010, The Threshold of Innovation, Somers, NY, 2004 from http://www-935.ibm.com/services/de/bcs/pdf/2006/pharma_2010.pdf (accessed 27 December, 2012).
    • (2010)
  • 24
    • 57749086529 scopus 로고    scopus 로고
    • Consideration for developing biopharmaceuticals: FDA perspective, in Modern Biopharmaceuticals
    • part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Brorson, K. et al. (2005) Consideration for developing biopharmaceuticals: FDA perspective, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1637- 1667.
    • (2005) Design, Development and Optimization , vol.4 , pp. 1637-1667
    • Brorson, K.1
  • 25
    • 84889956486 scopus 로고    scopus 로고
    • The regulatory environment for biopharmaceuticals in the EU, in Modern Biopharmaceuticals
    • part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Wenzel, A.F. and Sonnega, C.E.A. (2005) The regulatory environment for biopharmaceuticals in the EU, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1669- 1701.
    • (2005) Design, Development and Optimization , vol.4 , pp. 1669-1701
    • Wenzel, A.F.1    Sonnega, C.E.A.2
  • 26
    • 84889970670 scopus 로고    scopus 로고
    • Large-scale detection of genetic variation: the key to personalized medicine, in Modern Biopharmaceuticals
    • part I (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Geistlinger, J. and Ahnert, P. (2005) Large-scale detection of genetic variation: the key to personalized medicine, in Modern Biopharmaceuticals - Design, Development and Optimization, part I (ed. J. Knablein), Wiley-VCH Verlag GmbH, vol. 1, p. 71-93.
    • (2005) Design, Development and Optimization , vol.1 , pp. 71-93
    • Geistlinger, J.1    Ahnert, P.2
  • 27
    • 84885536813 scopus 로고    scopus 로고
    • The role of pharmacogenetics and pharmacongenomics, Modern Biop ha rmaceuticals De s i gn, D ev e lo p me n t a nd Optimization
    • part I (ed. J. Knablein) Wi le y-V CH Ve r la g G mbH
    • Huang, S .-M. an d Les ko, L. (2 005) The role of pharmacogenetics and pharmacongenomics, Modern Biop ha rmaceuticals - De s i gn, D ev e lo p me n t a nd Optimization, vol. 1, part I (ed. J. Knablein), Wi le y-V CH Ve r la g G mbH, p. 50-64.
    • (2005) , vol.1 , pp. 50-64
    • Huang, S.M.1    Les ko, L.2
  • 31
    • 84885515865 scopus 로고    scopus 로고
    • US FDA Guidance for Industry
    • May
    • US FDA (2006) Guidance for Industry, Q8 Pharmaceutical Development, May
    • (2006) Q8 Pharmaceutical Development
  • 33
    • 34247474373 scopus 로고    scopus 로고
    • Quality: design space for biotech products
    • Rathore, A.S., Branning, R., and Cecchini, D. (2007) Quality: design space for biotech products. BioPharm, 20 (4).
    • (2007) BioPharm , vol.20 , Issue.4
    • Rathore, A.S.1    Branning, R.2    Cecchini, D.3
  • 34
    • 46249092863 scopus 로고    scopus 로고
    • High-throughput screening of chromatographic separations: I. method development and column modeling
    • Coffman, J.L., Kramarczyk, J.F., and Kelley, B.D. (2008) High-throughput screening of chromatographic separations: I. method development and column modeling. Biotechnol. Bioeng., 100 (4), 605-618.
    • (2008) Biotechnol. Bioeng. , vol.100 , Issue.4 , pp. 605-618
    • Coffman, J.L.1    Kramarczyk, J.F.2    Kelley, B.D.3
  • 36
    • 84885520936 scopus 로고    scopus 로고
    • Utilizing an advanced high-throughput microbioreactor experimentation system. Presented at PDA
    • San Diego CA, January 2007
    • Stokelman, A. (2007) Utilizing an advanced high-throughput microbioreactor experimentation system. Presented at PDA: Emerging Manufacturing and Quality Control Technologies, San Diego CA, January 2007.
    • (2007) Emerging Manufacturing and Quality Control Technologies
    • Stokelman, A.1
  • 37
    • 84885504977 scopus 로고    scopus 로고
    • Chapter 2 Process capability in Handbook of Process Chromatography
    • Hagel, L., Jagschies, G., and Sofer, G. (2007) Chapter 2: Process capability in Handbook of Process Chromatography, 2nd edn, Elsevier Academic Press, pp. 23-39.
    • (2007) 2nd edn, Elsevier Academic Press , pp. 23-39
    • Hagel, L.1    Jagschies, G.2    Sofer, G.3
  • 38
    • 84885537286 scopus 로고    scopus 로고
    • Impact and benefits of applying QbD in cell line development to downstream process development
    • Boston MA, October 1
    • Reddy, P. (2007) Impact and benefits of applying QbD in cell line development to downstream process development. Presented at IBC Bioprocess International, Boston MA, October 1.
    • (2007) Presented at IBC Bioprocess International
    • Reddy, P.1
  • 39
    • 84885540505 scopus 로고    scopus 로고
    • A new technology standard for safety and efficacy in factor VIII replacement therapy: designing an advanced category rFVIII concentrate, in Modern Biopharmaceuticals
    • part II (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Riedel, N. and Dorner, F. (2005) A new technology standard for safety and efficacy in factor VIII replacement therapy: designing an advanced category rFVIII concentrate, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 2, part II (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 419-447.
    • (2005) Design, Development and Optimization , vol.2 , pp. 419-447
    • Riedel, N.1    Dorner, F.2
  • 40
    • 77956945657 scopus 로고    scopus 로고
    • Alternative strategies and new cell lines for high-level production of biopharmaceuticals
    • part IV (ed. J. Knablein), Wiley-VCH VerlagGmbH
    • Rose, T.,Winkler, K., Brundke, E., et al. (2005) Alternative strategies and new cell lines for high-level production of biopharmaceuticals, in Modern Biopharmaceuticals - Design,Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH VerlagGmbH, p. 761-776.
    • (2005) in Modern Biopharmaceuticals Design,Development and Optimization , vol.3 , pp. 761-776
    • Rose, T.1    Winkler, K.2    Brundke, E.3
  • 42
    • 84889996874 scopus 로고    scopus 로고
    • Use of the glutamine synthetase (GS) expression system for the rapid development of highly productive mammalian cell processes, in Modern Biopharmaceuticals
    • part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Birch, J.R., Mainwaring, D.O., and Racher, A.J., Use of the glutamine synthetase (GS) expression system for the rapid development of highly productive mammalian cell processes, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 809-830.
    • Design, Development and Optimization , vol.3 , pp. 809-830
    • Birch, J.R.1    Mainwaring, D.O.2    Racher, A.J.3
  • 43
    • 84885513817 scopus 로고    scopus 로고
    • Platform facility fit issues for high titer processes
    • Anaheim, CA, September 26
    • Trexler-Schmidt, M. (2008) Platform facility fit issues for high titer processes. Presented at IBC Bioprocess International, Anaheim, CA, September 26.
    • (2008) Presented at IBC Bioprocess International
    • Trexler-Schmidt, M.1
  • 44
    • 84885524979 scopus 로고    scopus 로고
    • Reconfiguration of a commercial biologics facility to a launch facility for new product introductions: balancing process and engineering solutions
    • Anaheim, CA, Septermber 26
    • Gadam, S. (2008) Reconfiguration of a commercial biologics facility to a launch facility for new product introductions: balancing process and engineering solutions. Presented at IBC Bioprocess International, Anaheim, CA, Septermber 26.
    • (2008) Presented at IBC Bioprocess International
    • Gadam, S.1
  • 45
    • 35348866110 scopus 로고    scopus 로고
    • Very large scale monoclonal antibody purification: the case for conventional unit operations
    • Kelley, B. (2007) Very large scale monoclonal antibody purification: the case for conventional unit operations. Biotechnol. Prog., 23, 995-1008.
    • (2007) Biotechnol. Prog. , vol.23 , pp. 995-1008
    • Kelley, B.1
  • 46
    • 84889956145 scopus 로고    scopus 로고
    • Producing modern biopharmaceuticals, in Modern Biopharmaceuticals
    • part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Apeler, H. (2005) Producing modern biopharmaceuticals, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1021-1031.
    • (2005) Design, Development and Optimization , vol.3 , pp. 1021-1031
    • Apeler, H.1
  • 47
    • 84889958106 scopus 로고    scopus 로고
    • Humanized glycosylation: production of biopharmaceuticals in a moss bioreactor, in Modern Biopharmaceuticals
    • part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
    • Gorr, G. and Wagner, S. (2005) Humanized glycosylation: production of biopharmaceuticals in a moss bioreactor, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 919-927.
    • (2005) Design, Development and Optimization , vol.3 , pp. 919-927
    • Gorr, G.1    Wagner, S.2
  • 50
    • 33749236399 scopus 로고    scopus 로고
    • Established bioprocesses for producing antibodies as a basis for future planning. Adv. Biochem
    • Engin/Biotechnol., Springer Verlag Berlin, Heidelberg, published online 8 June
    • Farid, S.S. (2006) Established bioprocesses for producing antibodies as a basis for future planning. Adv. Biochem. Engin/Biotechnol., Springer Verlag Berlin, Heidelberg, published online 8 June.
    • (2006)
    • Farid, S.S.1


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