References
1. Reichert JM, Rosensweig CJ, Faden LB, Dewitz MC. Monoclonal antibodies successes in the clinic. Nat Biotechnol. 2005;23:1073–1078.
2. Gottschalk U. The renaissance of protein purification. Supplement to BioPharm Int. 2006 June.
3. Datar RV, Cartwright, T., Rosen, C. Process economics of animal cell and bacterial fermentations: a case study analysis
of tPA. Bio/Technol. 1993;11:349–357.
4. Sadana A, Beelaram AM. Efficiency and economics of bioseparation: some case studies. Bioseparation. 1994;4:221–235.
5. Clemento A. New and integrated approaches to successful accelerated drug development. Drug Information J. 1999;33:699–710.
6. Mitchell P. Next-generation monoclonals less profitable than trailblazers? Nature Biotechnol. 2005;23:906.
7. Farid SS, Washbrook J, Titchener-Hooker NJ. Decision-support tool for assessing bio-manufacturing strategies under uncertainty:
stainless steel versus disposable equipment for clinical trial material preparation. Biotechnol Progress. 2005;21(2),486–497.
8. Kamarck ME. Building biomanufacturing capacity—the chapter and verse Nat Biotechnol. 2006;24:503–505.
9. Sommerfeld S, Strube J. Challenges in biotechnology production—generic processes and process optimization for monoclonal
antibodies. Chem Eng Proc. 2005;44(10):1123–1137.
10. Werner RG. Economic aspects of commercial manufacture of biopharmaceuticals. J Biotechnol. 2004;113:171–182.
11. Li F, Zhou JX, Yang X, Tressel T, Lee B. Current therapeutic antibody production and process optimization. BioProcessing
J. 2005 Sept/Oct;1–8.
12. Wheelwright SM. Protein purification: design and scale-up of downstream processing. New York: Hanser; 1991. chapter 1.
13. Dowd C, van Reis R. Cost reduction strategies in recovery process design. Proceedings of IBC's 4th International Conference
on Production and Economics of Biopharmaceuticals; 2001 Nov 14–15. San Diego, CA.
14. Ultee ME, Rea DW. Antibody purification. In: Flickinger MC, Drew SW, editors. Encyclopedia of bioprocess technology:
fermentation, biocatalysis, and bioseparation. New York: Wiley; 1999. vol 1.
15. Carson KL. Flexibility—the guiding principle for antibody manufacturing. Nat Biotechnol. 2005;23:1054-1058.
16. Kelley B. Very large scale monoclonal antibody purification: the case for conventional unit operations. Biotechnol Prog.
2007;23(5):995–1008.
17. Farid S. A decision-support tool for simulating the process and business perspectives of biopharmaceutical manufacture
[PhD thesis]. London (UK): University of London; 2001.
18. Farid SS, Washbrook J, Titchener-Hooker NJ. Combining multiple quantitative and qualitative goals when assessing biomanufacturing
strategies under uncertainty. Biotechnol Prog. 2005;21(4):1183–1191.
19. Hodge G. Disposable components enable a new approach to biopharmaceutical manufacturing. BioPharm Int. 2004;17(3):38–49.
20. Watler PK. Cost and capacity comparison of transgenics and cell culture production systems. Proceedings of IBC's 4th
International Conference on Production and Economics of Biopharmaceuticals; 2001 Nov 14–15. San Diego, CA.
21. Lewis-Sandy D. Optimizing consumables reuse for therapeutic protein production. Proceedings of IBC's 4th International
Conference on Production and Economics of Biopharmaceuticals; 2001 Nov 14–15. San Diego, CA.
22. Rathore AS, Latham P, Levine H, Curling J, Kaltenbrunner O. Costing issues in the production of biopharmaceuticals. BioPharm
Int. 2004 Feb.
23. Blank GS, Zapata G, Fahrner R, Milton M, Yedinak C, Knudsen H, Schmelzer C. Expanded bed adsorption in the purification
of monoclonal antibodies: a comparison of process alternatives. Bioseparation. 2001;10:65–71.
24. Jagschies G, Grönberg A, Björkman T, Lacki K, Johansson HJ. Technical and economical evaluation of downstream processing
options for monoclonal antibody (MAb) production. BioPharm Int. 2006 June.
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