Application of a decision-support tool to assess pooling strategies in perfusion culture processes under uncertainty

Biotechnology Progress

Volumn 21, Issue 4, 2005, Pages 1231-1242

  Ai, Chye Lim ^a   Zhou, Yuhong ^a   Washbrook, John ^a   Sinclair, Andrew ^b   Fish, Brendan ^c   Francis, Richard ^d   Titchener Hooker, Nigel John ^a   Farid, Suzanne S ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b BioPharm Services UK   (United Kingdom)

^c MEDIMMUNE LTD   (United Kingdom)

^d BIOCOMPATIBLES UK LTD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CELLS; DECISION MAKING; DECISION SUPPORT SYSTEMS; PROTEINS; RISK ASSESSMENT;

BIOPHARMACEUTICAL MANUFACTURERS; OPERATIONAL COSTS; PROCESS PARAMETERS; RISK FACTORS;

DRUG PRODUCTS;

MONOCLONAL ANTIBODY;

ANIMAL; ARTICLE; BIOTECHNOLOGY; CELL CULTURE; COST; DECISION MAKING; DRUG INDUSTRY; DRUG STABILITY; ECONOMICS; INSTRUMENTATION; MAMMAL; METABOLISM; METHODOLOGY; MONTE CARLO METHOD; ORGANIZATION AND MANAGEMENT; PERFUSION;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOTECHNOLOGY; CELLS, CULTURED; COSTS AND COST ANALYSIS; DECISION MAKING; DRUG INDUSTRY; DRUG STABILITY; MAMMALS; MONTE CARLO METHOD; PERFUSION;

MAMMALIA;

EID: 23244458243     PISSN: 87567938     EISSN: None     Source Type: Journal    
DOI: 10.1021/bp049578t     Document Type: Article

References (24)

1. Byrom, D. Role and Timing of Process Development for Biopharmaceutical Manufacture. Pharm. Technol. Eur. 2000, 12, 52-56.
2. Clemento, A. New and Integrated Approaches to Successful Accelerated Drug Development. Drug Inf. J. 1999, 33, 669-710.
3. DiMasi, J. A.; Hansen, R. W.; Grabowski, H. G. The Price of Innovation: New Estimates of Drug Development Costs. J. Health Econ. 2003, 22, 151-185.
4. Evans, L. B.; Field, R. P. Bioprocess Simulation: A New Tool for Process Development. Chem. Eng. Aust. 1989, 14 (4), 20-23.
5. 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.
6. Farid, S. S.; Washbrook, J.; Titchener-Hooker, N. J. Decision-Support Tool for Assessing Bio-Manufacturing Strategies under Uncertainty: Stainless Steel versus Disposable Equipment for Clinical Trial Material Preparation. Biotechnol. Prog. 2005, 21 (2), 486-497.
7. Fisher, M. P.; Pascucci, V. L. Regulatory Reflections Concerning the State of Biotechnology Progress. Drug Inf. J. 1996, 30, 41-46.
8. Foo, F.; Karri, S.; Davies, E.; Titchener-Hooker, N. J.; Dunnill, P. Biopharmaceutical Process Development: Part I, Information from the First Product Generation. BioPharm Eur. 2001, Jun, 58-64.
9. Garber, K. Biotech Industry Faces New Bottleneck. Nat. Biotechnol. 2001, 19, 184-185.
10. Gosling, I. The Role of Computer Simulation in the Bioprocessing Industry. BioPharm 1996, Jan.
11. Gritsis, D.; Titchener-Hooker, N. J. Biochemical Process Simulation. IChemE Symp. Ser. 1989, 114, 69-77.
12. Holmer, A. F. New Biotechnology Medicines in Development, 2002, Pharmaceutical Research and Manufacturers of America (PhRMA); http://www.phrma.org.
13. Hu, W. S.; Aunins, J. G. Large-scale Mammalian Cell Culture. Curr. Opin. Biotechnol. 1997, 148-153.
14. Karri, S.; Washbrook, J.; Titchener-Hooker, N. J. A Hierarchical Modelling Framework for Prototyping the Biopharmaceutical Drug Development Process. Proceedings of the AIChE Spring National Meeting, Atlanta, March, 2000; American Institute of Chemical Engineers: New York, 2000.
15. Lim, A. C. A Decision-Support Tool for Strategic Decision-Making in Biopharmacetical Manufacture. Ph.D. Thesis, University College London, 2004.
16. Lim, A. C.; Zhou, Y.; Washbrook, J.; Titchener-Hooker, N. J.; Farid, S. A Decision-Support Tool to Model the Impact of Regulatory Compliance Activities in the Biomanufacturing Industry. Comput. Chem. Eng. 2004, 28 (5), 727-735.
17. Petrides, D. P. BioPro Designer: An Advanced Computing Environment for Modelling and Design of Integrated Biochemical Processes. Comput. Chem. Eng. 1994, 18S, S621-S625.
18. Petrides, D. P.; Calandranis, J.; Cooney, C. Computer-Aided Design Techniques for Integrated Biochemical Processes. Genet. Eng. News 1995, 10, 28, 29, 35.
19. Petrides, D. P.; Sapidou, E. S. Optimization of Protein Recovery Using Computer-Aided Process Design Tools. In Handbook of Downstream Processing; Goldberg, E., Ed.; Blackie Academic & Professional: London, New York, 1997.
20. Reichert, J. M. New Biopharmaceuticals in the USA: trends in development and marketing approvals 1995-1999. Trends Biotechnol. 2000, 18, 364-369.
21. Reichert, J. M.; Pavlou, A. Monoclonal Antibodies Market. Nat. Rev. Drug Discovery 2004, 3, 383-384.
22. Remer, D. S.; Idrovo, J. H. Cost-Estimating Factors for Biopharmaceutical Process Equipment. Pharm. Technol. Int. 1991, Mar, 36-42.
23. Shanklin, T.; Roper, K.; Yegneswaran, P. K.; Marten, M. R. Selection of Bioprocess Simulation Software for Industrial Applications. Biotechnol. Bioeng. 2001, 72 (4), 483-489.
24. Sinnott, R. K. In Coulson & Richardson's Chemical Engineering (Design); Pergamon Press: Oxford, 1993; Vol. 6.