Skip to main content

Mammalian Cell Culture Capacity for Biopharmaceutical Manufacturing

Part of the Advances in Biochemical Engineering/Biotechnology book series (ABE,volume 139)

Keywords

  • Biomanufacturing
  • Biopharmaceuticals
  • Capacity
  • Contract manufacturing
  • Excess capacity
  • Forecast
  • Mammalian cell culture
  • Single-use

This is a preview of subscription content, access via your institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • DOI: 10.1007/10_2013_215
  • Chapter length: 41 pages
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
eBook
USD   349.00
Price excludes VAT (USA)
  • ISBN: 978-3-642-54050-9
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Hardcover Book
USD   449.99
Price excludes VAT (USA)
Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8
Fig. 9
Fig. 10
Fig. 11
Fig. 12
Fig. 13

Abbreviations

BLA:

Biologics License Application

BPSA:

BioProcess Systems Alliance

CMO:

Contract manufacturing organization

GMP:

Good manufacturing practice

MAA:

Marketing Authorization Application

ROW:

Rest of world

WFI:

Water for injection

References

  1. BioProcess Technology Consultants (2011) The State of Mammalian Cell Culture Biomanufacturing. BioProcess Technology Consultants, Inc. http://www.bptc.com/ECommerce/Reports. Accessed 31 Dec 2012

  2. Norman P (2011) Monoclonal antibodies in the pipeline: a segment of major growth. Cambridge Healthtech Institute. http://www.insightpharmareports.com/monoclonalantibodiesreport. Accessed 31 Dec 2012

  3. Visiongain (2011) Therapeutic monoclonal antibodies: world market 2011–2021. Visiongain LTD. http://www.visiongain.com/Report/685/Therapeutic-Monoclonal-Antibodies-World-Market-2011-2021. Accessed 31 Dec 2012

  4. Ginsberg PL et al (2002) The road ahead for biologics manufacturing. U.S. Bancorp Piper Jaffray Equity Research

    Google Scholar 

  5. Molowa DT (2001) The state of biologics manufacturing. J.P. Morgan Securities Inc., New York

    Google Scholar 

  6. Molowa DT (2002) The state of biologics manufacturing: part 2. J.P. Morgan Securities Inc., New York

    Google Scholar 

  7. Diamasi JA et al (2003) The price of innovation: new estimates of drug development costs. J Health Econ 22(2):151–185

    Google Scholar 

  8. Pavlou AK, Reichert JM (2004) Recombinant protein therapeutics-success rates, market trends and values to 2010. Nat Biotechnol 22(12):1513–1519

    Google Scholar 

  9. Algra D (2002) Dealing with the capacity crunch in biopharma. Presented at bioLOGIC2002, 5–7 June 2002, Geneva

    Google Scholar 

  10. Downey W (2008) Biopharma CMO market report. Contract Pharma 10(4):58–63

    Google Scholar 

  11. Liu C, Downey W (2010) State of the Bio-CMO market. Contract Pharma 12(3):54–59

    Google Scholar 

  12. Soiron R (2011) Lonza 2011 full year results—25 January 2012. Lonza Group Ltd. http://www.lonza.com/~/media/Assets/about-lonza/Investor%20Information%20-%20All%20Reports%20Presentation/20120125FYR.ashx. Accessed 31 Dec 2012

  13. Boehringer Ingelheim GmbH (2011) Corporate Magazine 2011 annual report. Boehringer Ingelheim GmbH. http://www.boehringer-ingelheim.com/content/dam/internet/opu/com_EN/document/01_news/08_APC/APC_2012/BoehringerIngelheim_Annual_Report_2011_complete.pdf. Accessed 31 Dec 2012

  14. Downey W (2012) Bio-CMO industry trends. Contract Pharma 14(4):70–75

    Google Scholar 

  15. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Office of Regulatory Affairs (US) (2008) Guidance for industry—cGMP for phase I investigational drugs. Department of Health and Human Services. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070273.pdf. Accessed 31 Dec 2012

  16. Reynolds EB (2011) The changing geography of biomanufacturing. The Industrial Performance Center, Massachusetts Institute of Technology. http://web.mit.edu/ipc/publications/pdf/IPC11-001.pdf. Accessed 31 Dec 2012

  17. Machulski J (2002) Case study of Lonza’s 20,000 L cell culture facility project. Presented at Barnett international’s biomanufacturing conference, 30 Sept 2002–1 Oct 2002, Boston, MA

    Google Scholar 

  18. Stout J (2011) Shire’s manufacturing strategy and new flexible facility. Presented at International Business Communication Life Sciences’ Seventh international biopharmaceutical manufacturing and development summit, 12–14 Sept 2011, San Diego, CA

    Google Scholar 

  19. Ciambrone B (2011) Bravely deploying single use technologies at commercial scale. Presented at International Business Communication Life Sciences’ Eighth international single-use applications for biopharmaceutical manufacturing conference, 6–8 June 2011, Boston, MA

    Google Scholar 

  20. Jones SD, Ransohoff TC (2011) Single use products for bioproduction: available options for cell culture and downstream processing. Am Pharm Rev 14(4):12–20

    Google Scholar 

  21. Roebers JR (2009) Future trends in biopharmaceutical operations and facilities. Presented at International Business Communications Life Sciences’ Bioprocess international conference, 12–16 Oct 2009, Raleigh, NC

    Google Scholar 

  22. Hodge G (2004) Disposable components enable a new approach to biopharmaceutical manufacturing. BioPharm Int 17(3):38–49

    Google Scholar 

  23. Fromison J (2009) Disposables in clinical manufacturing. Am Pharm Rev 12(2):20–27

    Google Scholar 

  24. Ransohoff TC (2011) Manufacturing capacity trends and disposable technologies. Presented at the World Antibody Manufacturing and Development Summit, Pre-conference workshop, 24 May 2011, Boston, MA

    Google Scholar 

  25. Levine HL (2009) Challenges and solutions for biopharmaceutical manufacturing. Presented at Cambridge HealthTech Institute, PepTalk conference, 14–20 Jan 2009, San Diego, CA

    Google Scholar 

  26. Steininger B (2008) Platform technology to accelerate drug discovery and development—a small company’s CMC approach to understand GDF biology. Presented at the International Society for Pharmaceutical Engineering’s 2008 annual meeting, 26–29 Oct 2008, Boca Raton, FL

    Google Scholar 

  27. Brodeur CM (2011) What’s next after achieving rapid capacity increase and flexibility through the use of disposables? Presented at International Business Communications Life Sciences’ Seventh international biopharmaceutical manufacturing and development summit, 12–14 Sept 2011, San Diego, CA

    Google Scholar 

  28. Singh V (1999) Disposable bioreactor for cell culture using wave-induced agitation. Cytotechnology 30(1–3):149–158

    CAS  CrossRef  Google Scholar 

  29. Eibl R et al (2010) Disposable bioreactors: the current state-of-the-art and recommended applications in biotechnology. Appl Microbiol Biotechnol 86(1):41–49

    CAS  CrossRef  Google Scholar 

  30. Robinson JM (2009) An alternative to the scale-up and distribution of pandemic influenza vaccine. Biopharm Int 22(Suppl):12–20

    Google Scholar 

  31. Noe W (2011) A brief review on evolving cell culture based manufacturing processes & technology drivers over the past 25 years. Presented at Cambridge Healthtech Institute’s Peptalk conference, 13–17 Jan 2011, San Diego, CA

    Google Scholar 

  32. Smelko JP et al (2011) Performance of high intensity fed-batch mammalian cell cultures in disposable bioreactor systems. Biotechnol Prog 27(5):1358–1364

    CAS  CrossRef  Google Scholar 

  33. Craig J, Bhella R (2011) A step towards standardizing films for single-use bioprocessing vessels. BioProcess Int 9(Suppl 2):42–46

    Google Scholar 

  34. Whitford W (2011) Improving process monitoring capabilities in SUB bioprocess development. Presented at International Business Communications Life Sciences’ Antibody development and production week, 16–18 March 2011, Bellevue, WA

    Google Scholar 

  35. ATMI, Inc. (2011) ATMI announces helium integrity testing for single-use bioprocess vessels. ATMI, Inc. http://files.shareholder.com/downloads/ATMI/1541192980x0x455083/3d94c718-a252-4e70-af65-373dea6e24bb/ATMI_News_2011_3_29_General_Releases.pdf. Accessed 31 Dec 2012

  36. Ransohoff TC (2012) The use of disposable technologies in biopharmaceutical purification processes. Presented at American Association of Pharmaceutical Scientists’ annual meeting and exposition, 14–18 Oct 2012, Chicago, IL

    Google Scholar 

  37. Pollard D (2012) Extracting the full potential of single use. Presented at International Business Communication Life Sciences’ Ninth annual single-use applications for biopharmaceutical manufacturing conference, 14–16 June 2012, San Francisco, CA

    Google Scholar 

  38. Lee EK (2010) Single-use technologies in biologics and vaccines manufacturing industries. Presented at the fourth national conference on clinical research vaccines and biologics summit 2010, 4 June 2010, Kuala Lumpur, Malaysia

    Google Scholar 

  39. GE Healthcare Life Sciences (2012) GE Healthcare launches modular biopharmaceutical factory, KUBio. GE Healthcare Life Sciences. http://www.genewscenter.com/Press-Releases/GE-Healthcare-launches-modular-biopharmaceutical-factory-KUBio-3ac1.aspx. Accessed 31 Dec 2012

  40. Sinclair A et al (2008) The environmental impact of disposable technologies. BioPharm Int 21(Suppl 11):S4–S11

    Google Scholar 

  41. Rawlings B, Pora H (2009) Environmental impact of single-use and reusable bioprocess systems. Bioprocess Int 7(2):18–25

    Google Scholar 

  42. Pora H, Rawlings B (2009) Managing solid waste from single-use systems in biopharmaceutical manufacturing. Bioprocess Int 7(1):18–25

    Google Scholar 

  43. Disposables Subcommittee of the Bio-Process Systems Alliance (2007) Guide to disposal of single-use bioprocess system. Bioprocess Int 5(11):22–28

    Google Scholar 

  44. Hagen B (2011) CMO management: resolving problems, mitigating risks, and capturing opportunities. Presented at the International Quality and Productivity Center’ 12th contract manufacturing for pharmaceuticals and biotech conference, 23–25 May 2011, Berkeley, CA

    Google Scholar 

  45. Wright R (2011) Buttoning down the pharma supply chain. Life Science Leader. http://www.lifescienceleader.com/magazine/past-issues3/item/3628-buttoning-down-the-pharma-supply-chain. Accessed 31 Dec 2012

  46. Darnell JR (2010) Time to revisit supplier quality management. BioPharm Int 25(11):18–20

    Google Scholar 

  47. Martin J (2011) Single-use technology-balancing the risks and rewards. BioPharm Int 24(Suppl):22–25

    Google Scholar 

  48. Steininger B (2011) Challenges in using single-use systems for pilot development and GMP process. Presented at International Business Communications Life Sciences’ Eighth international single-use applications for biopharmaceutical manufacturing conference, 6–8 June 2011, Boston, MA

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Dawn M. Ecker .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and Permissions

Copyright information

© 2013 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

Ecker, D.M., Ransohoff, T.C. (2013). Mammalian Cell Culture Capacity for Biopharmaceutical Manufacturing. In: Zhou, W., Kantardjieff, A. (eds) Mammalian Cell Cultures for Biologics Manufacturing. Advances in Biochemical Engineering/Biotechnology, vol 139. Springer, Berlin, Heidelberg. https://doi.org/10.1007/10_2013_215

Download citation