Modelling biopharmaceutical manufacture: Design and implementation of SimBiopharma

Computers and Chemical Engineering

Volumn 31, Issue 9, 2007, Pages 1141-1158

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

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Biopharmaceutical batch manufacture; Computer aided simulation; Costs; Decision support tool; Object oriented; Uncertainty

Indexed keywords

COMPUTER SIMULATION; DECISION SUPPORT SYSTEMS; HIERARCHICAL SYSTEMS; MATHEMATICAL MODELS; OBJECT ORIENTED PROGRAMMING; PROCESS CONTROL;

BIOPHARMACEUTICAL BATCH MANUFACTURE; COMPUTER-AIDED SIMULATION; DECISION-SUPPORT TOOL;

DRUG PRODUCTS;

COMPUTER SIMULATION; DECISION SUPPORT SYSTEMS; DRUG PRODUCTS; HIERARCHICAL SYSTEMS; MATHEMATICAL MODELS; OBJECT ORIENTED PROGRAMMING; PROCESS CONTROL;

EID: 34248657946     PISSN: 00981354     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.compchemeng.2006.10.020     Document Type: Article

References (52)

1. Atkinson B., and Mavituna F. Biochemical engineering and biotechnology handbook. 2nd ed. (1991), Stockton Press, Basingstoke: Macmillan. New York, N.Y Chapter 19
2. Banks J. Principles of simulation. In: Banks J. (Ed). Handbook of simulation: Principles, methodology, advances, applications, and practice (1998), Wiley, Engineering & Management Press, Chichester 3-30
3. Bastiaan H.K. Process model and recipe structure. The conceptual design for a flexible batch plant. ISA Transactions 36 4 (1998) 249-255
4. Bernstein D.F., and Hamrell M.R. Integrating drug supply issues with strategic preclinical and clinical development. Drug Inf. J. 34 (2000) 909-917
5. Bogle I.D.L., Cockshott A.R., Bulmer M., Thornhill N., Gregory M., and Dehgant M. A process systems engineering view of biochemical process operations. Comput. Chem. Eng. 20 6-7 (1996) 943-949
6. Byrom D. Role and timing of process development for biopharmaceutical manufacture. Pharm. Technol. Eur. (BioPharm Eur.) 12 3 (2000) 52-56
7. Chadd H.E., and Chamow S.C. Therapeutic antibody expression technology. Curr. Opin. Biotechnol. 12 (2001) 188-194
8. Clemento A. New and integrated approaches to successful accelerated drug development. Drug Inf. J. 33 (1999) 699-710
9. Copmann T., Davis G., Garnick R., Landis J., Lubiniecki A., Massa T., et al. One product, one process, one set of specifications: A proven quality paradigm for the safety and efficacy of biologic drugs. BioPharm. (2001) 14-24
10. Crowl T.E. S88.01 Concepts streamline control software application for biotech plant. ISA Tech/Expo Technology Update Conference Proceedings, 1 (2) (1997) 131-141
11. Datar R.V., Cartwright T., and Rosen C. Process economics of animal cell and bacterial fermentations: A case study analysis of tPA. Bio/Technology 11 (1993) 349-357
12. Farid S.S., Washbrook J., and 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. 21 2 (2005) 486-497
13. Farid S.S., Washbrook J., and Titchener-Hooker N.J. Combining multiple quantitative and qualitative goals when assessing biomanufacturing strategies under uncertainty. Biotechnol. Prog. 21 4 (2005) 1183-1191
14. Farid S., Novais J.L., Karri S., Washbrook J., and Titchener-Hooker N.J. A tool for modelling strategic decisions in cell culture manufacturing. Biotechnol. Prog. 16 5 (2000) 829-836
15. Gosling I. The role of computer simulation in the bioprocessing industry. BioPharm. Jan. (1996)
16. Gregersen J. Biomedicinal product development. In: Rehm H.-J., Reed G., Puhler A., Stadler P., and Brauer D. (Eds). Biotechnology: Legal, economic and ethical dimensions. 2nd ed. vol. 12 (1995), VCH, Weinheim 213-237
17. Gritsis D., and Titchener-Hooker N.J. Biochemical process simulation. IChemE Symposium Series, 114 (1989) 69-77
18. Hamers M.N. Multiuse biopharmaceutical manufacturing. Bio/Technology (1993) 561-570 May
19. Hayes R.H., and Wheelwright S.C. Restoring our competitive edge: Competing through manufacturing (1984), Wiley, New York: Chichester
20. Johnsson C., and Arzen K.-E. Grafchart for recipe-based batch control. Comput. Chem. Eng. 22 12 (1998) 1811-1828
21. Karri S., Davies E., Titchener-Hooker N.J., and Washbrook J. Biopharmaceutical process development: Part III A framework to assist decision making. Biopharm Eur. (2001) 76-82
22. Kelley B.D. Bioprocessing of therapeutic proteins. Curr. Opin. Biotechnol. 12 2 (2001) 173-174
23. Knutilla A., Schlenoff C., Ray S., Polyak S.T., Tate A., Cheah S.C., et al. Process specification language: An analysis of existing representations. NISTIR 6160 (1998), National Institute of Standards and Technology, Gaithersburg, MD
24. Lakshmanan R., and Stephanopoulos G. Synthesis of operating procedures for complete chemical plants - I. Hierarchical structures modeling for non-linear planning. Comput. Chem. Eng. 12 9 (1998) 985-1002
25. Lang H.J. Simplified approach to preliminary cost estimates. Chem. Eng. 55 (1948) 112-113
26. Lim A.C., Zhou Y., Washbrook J., Sinclair A., Fish B., Francis R., et al. Application of a decision-support tool to assess pooling strategies in perfusion culture processes under uncertainty. Biotechnol. Prog. 21 4 (2005) 1231-1242
27. Lim A.C., Zhou Y., Washbrook J., Titchener-Hooker N.J., and Farid S.S. A computer-aided approach to compare the production economics of fed-batch versus perfusion culture. Biotechnol. Bioeng. 93 4 (2005) 687-697
28. Manivannan M.S. Simulation of logistics and transportation systems. In: Banks J. (Ed). Handbook of simulation: Principles, methodology, advances, applications, and practice (1998), Wiley Engineering & Management Press, Chichester 571-604
29. Mison D., and Curling J. The industrial production costs of recombinant therapeutic proteins expressed in transgenic corn. BioPharm. (2000) 48-54 May
30. Moilanen T., and Martin C. Financial evaluation of environmental investments (1996), Institution of Chemical Engineers, Rugby, England
31. Mustafa, M. A., Washbrook, J., Lim, A. C., Zhou, Y., Titchener-Hooker, N. J., & Morton, P., et al. (2004). A software tool to assist business-process decision making in the biopharmaceutical industry. Biotechnol. Prog., 20(4), 1096-1102 [Correction: Biotechnol. Prog., (2005), 21(1), 320].
32. Nelson K. Cell culture manufacturing: An economic perspective from an engineering consultant. US Biotechnology Symposium. Washington, DC, Nov-Dec (1998)
33. Novais J.L., Titchener-Hooker N.J., and Hoare M. Economic comparison between conventional and disposables-based technology for the production of biopharmaceuticals. Biotechnol. Bioeng. 75 2 (2001) 143-153
34. Osborne A. Evaluation of project economic viability (1997), Presented at MBI Training Programme: Design II, UCL, UK May
35. Peters M.S., and Timmerhaus K.D. Plant design and economics for chemical engineers (1991), McGraw-Hill, London, New York Chapter 6
36. Petrides D.P., and Sapidou E.S. Optimization of protein recovery using computer-aided process design tools. In: Goldberg E. (Ed). Handbook of downstream processing (1997), Blackie Academic & Professional, London, New York
37. Petrides D.P., Calandranis J., and Cooney C. Computer-aided design techniques for integrated biochemical processes. Genet. Eng. News. Sep. 10 28-29 (1995) 35
38. Pisano G., and Wheelwright S.C. High-tech R&D. Harvard Business Review (1995) 93-105
39. Polakovic M., and Mandenius C.F. Simulation of a complex biotechnological process using an object-oriented knowledge-based system. In: Moreira A.R., and Wallace K.K. (Eds). Computer and information science applications in bioprocess engineering (1996), Kluwer in cooperation with NATO Scientific Affairs Division, Dordrecht, London 157-163
40. Pugh G. Cell culture manufacturing: An economic perspective from a contract manufacturer's viewpoint. US Biotechnology Symposium. Washington, DC, Nov-Dec (1998)
41. Puigjaner L., and Espuna A. Prospects for integrated management and control of total sites in the batch manufacturing industry. Comput. Chem. Eng. 22 1-2 (1998) 87-107
42. Rajapakse A., Titchener-Hooker N.J., and Farid S.S. Modelling of the biopharmaceutical drug development pathway and portfolio management. Comput. Chem. Eng. 29 6 (2005) 1357-1368
43. Sadana A., and Beelaram A.M. Efficiency and economics of bioseparation: Some case studies. Bioseparation 4 (1994) 221-235
44. Savage C. Scaleup and bioproduction. Genet. Eng. News 1 65 (2000) 80
45. Shanklin T., Roper K., Yegneswaran P.K., and Marten M.R. Selection of bioprocess simulation software for industrial applications. Biotechnol. Bioeng. 72 4 (2001) 483-489
46. Sinnott R.K. Coulson and Richardson's chemical engineering (chemical engineering design Vol. 6 (1993), Pergamon Press, Oxford pp. 209-244
47. Sofer G., and Hagel L. Handbook of process chromatography: A guide to optimization, scale-up, and validation (1997), Academic Press, San Diego, CA, London Chapter 10
48. Stanley G.M. The emerging trend towards knowledge-based frameworks for computer-integrated manufacturing. Instrument Society of America ISA/94 Conference. Philadelphia, Pennsylvania, USA, May 1-5 (1994)
49. Stephanopoulos G., Ali S., Linninger A.A., and Salomone E. Batch process development: Challenging traditional approaches. AICHE Symposium Series, 96(323), 46-57 (2000)
50. Subrahmanyan S., Pekny J.F., and Reklaitis G.V. Decomposition approaches to batch plant design and planning. Ind. Eng. Chem. Res. 35 (1996) 1866-1876
51. Varga E.G., Titchener-Hooker N.J., and Dunnill P. Prediction of the pilot-scale recovery of a recombinant yeast enzyme using integrated models. Biotechnol. Bioeng. 74 2 (2001) 96-107
52. Zhou Y.H., Holwill I.L.J., and Titchener-Hooker N.J. A study of the use of computer simulations for the design of integrated downstream processes. BioProcess Eng. 16 (1997) 367-374