Decision-support tool for assessing biomanufacturing strategies under uncertainty: Stainless steel versus disposable equipment for clinical trial material preparation

Biotechnology Progress

Volumn 21, Issue 2, 2005, Pages 486-497

  Farid, Suzanne S ^a   Washbrook, John ^a   Titchener Hooker, Nigel J ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

COMPUTER SIMULATION; DECISION SUPPORT SYSTEMS; DRUG PRODUCTS; DRUG PRODUCTS PLANTS; MONTE CARLO METHODS; PROJECT MANAGEMENT; RISK ASSESSMENT;

BIOMANUFACTURING STRATEGIES; BIOPHARMACEUTICALS; DISPOSABLE EQUIPMENTS; RESOURCE UTILIZATION;

BIOTECHNOLOGY;

STAINLESS STEEL;

ARTICLE; CLINICAL TRIAL; DECISION SUPPORT SYSTEM; DISPOSABLE EQUIPMENT; MONTE CARLO METHOD;

CLINICAL TRIALS; DECISION SUPPORT TECHNIQUES; DISPOSABLE EQUIPMENT; MONTE CARLO METHOD; STAINLESS STEEL;

EID: 16344374342     PISSN: 87567938     EISSN: None     Source Type: Journal    
DOI: 10.1021/bp049692b     Document Type: Article

References (35)

1. Avgerinos, G. Biologics Manufacturing Risk Reduction Strategies. Presented at Biopharmaceutical Process Economics and Optimization, Washington, DC.; IBC, Sep. 30-Oct. 1, 1999.
2. Bernstein, D. F.; Hamrell, M. R. Integrating Drug Supply Issues with Strategic Preclinical and Clinical Development. Drug Inf. J. 2000, 34, 909-917.
3. Bibila, T. A.; Robinson, D. R. In Pursuit of the Optimal Fed-Batch Process for Monoclonal Antibody Production. Biotechnol. Prog. 1995, 11, 1-13.
4. Birch, J. R.; Bonnerjea, J.; Flatman, S.; Vranch, S. Production of monoclonal antibodies. In Monoclonal Antibodies: Principles and Application; Birch, J. R., Lennox, E. S., Eds.; Wiley-Liss, Inc.: New York, 1995; pp 231-265.
5. Breggar, M. M. Navigating Regulatory Maze Requires a Proactive Strategy. 1996 GEN Guides Editorial, 1996, 277-278.
6. Byrom, D. Role and Timing of Process Development for Biopharmaceutical Manufacture. Pharm. Technol. Eur. (BioPharm Eur.) 2000, 12 (3), 52-56.
7. Castillo, F. J. Hybridoma, Antibody Production. In Encyclopaedia of Bioprocess Technology: Fermentation, Biocatalysis and Bioseparation; Flickinger, M. C., Drew, S. W. Eds.; Wiley: New York, Chichester, 1999; Vol 5.
8. Chadd, H. E.; Chamow, S. C. Therapeutic Antibody Expression Technology. Curr. Opin. Biotechnol. 2001, 12, 188-194.
9. Clemento, A. New and Integrated Approaches to Successful Accelerated Drug Development. Drug Inf. J. 1999, 33, 699-710.
10. Farid, S. Industrial Antibody Production Processes: A Review. Adv. Biochem. Eng./Biotechnol. (in press)
11. Farid, S.; Novais, J. L.; Karri, S.; Washbrook, J.; Titchener-Hooker, N. J. A Tool for Modelling Strategic Decisions in Cell Culture Manufacturing. Biotechnol. Prog. 2000, 16 (5), 829-836.
12. Farid, S.; Washbrook, J.; Titchener-Hooker, N. J. Modelling Biopharmaceutical Manufacture: Design and Implementation of SIMBIOPHARMA. Comput. Chem. Eng. (submitted)
13. Foo, F.; Davies, E.; Titchener-Hooker, N. J.; Dunnill, P. Biopharmaceutical Process Development: Part 1, Information from the First Product Generation. Biopharm. Eur. 2001, 58-64.
14. Gerson, D. F. G.; Himes, V.; Hopper, R.; Khandke, L. Kohn, F.; Komotar, A.; Krumm, P.; Machulski, J.; Weisser, A.; Sciotto-Brown, S. Transfer of Processes from Development to Manufacturing. Drug Inf. J. 1998, 32, 19-26.
15. Hamers, M. N. Multiuse Biopharmaceutical Manufacturing. Bio/Technol. 1993, May, 561-570.
16. Hayes, R. H.; Wheelwright, S. C. Restoring Our Competitive Edge: Competing through Manufacturing; Wiley: New York, Chichester, 1984.
17. Kelley, B. D. Bioprocessing of Therapeutic Proteins. Curr. Opin. Biotechnol. 2001, 12 (2), 173-174.
18. Ladisch, M. R. Bioseparations Engineering: Principles, Practice, and Economics; Wiley: New York, Chichester, 2001; Chapter 8.
19. Lim, A. C.; Zhou, Y.; Washbrook, J.; Titchener-Hooker, N. J.; Farid, S. A Decisional-Support Tool To Model the Impact of Regulatory Compliance Activities in the Biomanufacturing Industry. Comput. Chem. Eng. 2004, 28 (5), 727-735.
20. Mackler, B. F.; Gamerman, G. E. A Perspective on Global Approval Strategies in the 1990s. 1996 GEN Guides Editorial 1996, 264-266.
21. Moilanen, T.; Martin, C. Financial Evaluation of Environmental Investments; Institution of Chemical Engineers: Rugby, England, 1996.
22. Mullen, J. The Position of Biopharmaceuticals in the Future. Presented at Production and Economics of Biopharmaceuticals-Transcending the Limits of Manufacturing Medicines; La Jolla CA, IBC., Nov. 13-15, 2000.
23. Mustafa, M. A.; Washbrook, J.; Lim, A. C.; Zhou, Y.; TitchenerHooker, N.; Morton, P.; Berezenko, S.; Farid, S. S. A Software Tool To Assist Business-Process Decision Making in the Biopharmaceutical Industry. Biotechnol. Prog. 2004, 20 (4), 1096-1102.
24. Mustafa, M. A.; Washbrook, J.; Lim, J.; Farid, S.; Titchener-Hooker, N. J. Novel software tools for evaluating integration within a downstream process: A case study of expanded-bed adsorption vs packed-bed adsorption. Presented at 225th American Chemical Society National Meeting, New Orleans, LA, 23-27 March, 2003.
25. Nelson, K. Cell Culture Manufacturing: An Economic Perspective from an Engineering Consultant. Presented at U.S. Biotechnology Symposium, Washington, DC, Nov-Dec, 1998.
26. Novais, J. L.; Titchener-Hooker, N. J.; Hoare, M. Economic Comparison Between Conventional and Disposables-Based Technology for the Production of Biopharmaceuticals. Biotechnol. Bioeng. 2001, 75 (2), 143-153.
27. Osborne, A. Evaluation of Project Economic Viability. Presented at MBI Training Programme: Design II, UCL, UK, May, 1997.
28. Sadana, A.; Beelaram, A. M. Efficiency and Economics of Bioseparation: Some Case Studies. Bioseparation 1994, 4, 221-235.
29. Savage, C. Scale-up and Bioproduction. Genet. Eng. News 2000, 65, 80.
30. Sinclair, A.; Monge, M. Quantitative Economic Evaluation of Single Use Disposables in Bioprocessing. Pharm. Eng. 2002, 22, 3, 20-34
31. Sinnott, R. K. Coulson and Richardson's Chemical Engineering (Chemical Engineering Design); Pergamon Press: Oxford, 1993; Vol. 6, pp 209-244.
32. Sofer, G.; Hagel, L. Handbook of Process Chromatography: A Guide to Optimization, Scale-up, and Validation; Academic Press: San Diego, London, 1997; Chapter 10.
33. Struck, M. M. Biopharmaceutical R&D Success Rates and Development Times. Bio/Technology 1994, 12, 675-677.
34. Walsh, G. Biopharmaceuticals: Biochemistry and Biotechnology; John Wiley & Sons: Chichester, 1998; Chapters 2, 3, and 10.
35. Xie, L.; Wang, D. I. C. High Cell Density and High Monoclonal Antibody Production through Medium Design and Rational Control in a Bioreactor. Biotechnol. Bioeng. 1996, 51, 725-729.