The integrated simulation and assessment of the impacts of process change in biotherapeutic antibody production

Biotechnology Progress

Volumn 22, Issue 6, 2006, Pages 1612-1620

  Chhatre, Sunil ^a   Jones, Carl ^b   Francis, Richard ^b   O'Donovan, Kieran ^b   Titchener Hooker, Nigel ^a   Newcombe, Anthony ^b   Keshavarz Moore, Eli ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b BIOCOMPATIBLES UK LTD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AFFINITY CHROMATOGRAPHY; ANTIBODIES; DRUG PRODUCTS PLANTS;

CHROMATOGRAPHIC MATRICES; ENZYMATIC DIGESTION; INTEGRATED PRODUCTION PROCESS;

BIOTECHNOLOGY;

CROTALIDAE POLYVALENT IMMUNE FAB; IMMUNOGLOBULIN FRAGMENT; VENOM ANTISERUM;

ARTICLE; CHEMICAL MODEL; CHEMISTRY; COMPUTER SIMULATION; DRUG DESIGN; DRUG FORMULATION; FRACTIONATION; IMMUNOLOGY; METHODOLOGY; SYSTEM ANALYSIS;

ANTIVENINS; CHEMICAL FRACTIONATION; COMPUTER SIMULATION; DRUG COMPOUNDING; DRUG DESIGN; IMMUNOGLOBULIN FRAGMENTS; MODELS, CHEMICAL; SYSTEMS INTEGRATION;

OVIS;

EID: 33845488129     PISSN: 87567938     EISSN: None     Source Type: Journal    
DOI: 10.1021/bp0602000     Document Type: Article

References (38)

1. Shillingford, C. A.; Vose, C. W. Effective decision-making: progressing compounds through clinical development. Drug Discovery Today 2001, 6 (18), 941-946.
2. 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, 143-153.
3. Drews, J.; Ryser, S. Pharmaceutical innovation between scientific opportunities and economic constraints. Drug Discovery Today 1997, 2 (9), 365-372.
4. Karri, S.; Davies, E.; Titchener-Hooker, N.; Washbrook, J. Biopharmaceutical process development. Part III: A framework to assist decision making. Biopharm Europe 2001, Sept, 76-82.
5. Karri, S.; Foo, F.; Titchener-Hooker, N. J.; Dunnill, P. Biopharmaceutical process development. Part I: Information from the first product generation. Biopharm Europe 2001, June, 58-64.
6. Schmid, E. F.; Smith, D. A. Discovery, innovation and the cyclical nature of the pharmaceutical business. Drug Discovery Today 2002, 7 (10), 563-568.
7. Tranter, D. Preparing for change. Pharm. Sci. Technol. Today 1999, 2 (3), 89-90.
8. Rooney, K. F.; Snoeck, E.; Watson, P.H. Modelling and simulation in clinical drug development. Drug Discovery Today 2001, 6 (15), 802-806.
9. Boychyn, M.; Yim, S. S. S.; Ayazi Shamlou, P.; Bulmer, M.; More, J.; Hoare, M. Characterization of flow intensity in continuous centrifuges for the development of laboratory mimics. Chem. Eng. Sci. 2001, 56, 4759-4770.
10. Lamping, S.; Zhang, H.; Allen, B.; Ayazi Shamlou, P. Design of a prototype miniature bioreactor for high throughput automated bioprocessing. Chem. Eng. Sci. 2003, 58 (3-6), 747-758.
11. AB fragment. Biotechnol. Bioeng. 2003, 81, 149-157.
12. Neal, G.; Francis, R.; Ayazi Shamlou, P.; Keshavarz-Moore, E. Separation of immunoglobulin G precipitate from contaminating proteins using microfiltration. Biotechnol. Appl. Biochem. 2004, 39, 241-248.
13. King, J. M. P.; Griffiths, P.; Zhou, Y.; Titchener-Hooker, N. J. Visualising bioprocesses using, '3D-Windows of Operation.' J. Chem. Technol. Biotechnol. 2004, 79, 518-525.
14. Rouf, S. A.; Douglas, P. L.; Moo-Young, M.; Scharer, J. M. Computer simulation for large scale bioprocess design. Biochem. Eng. J. 2001, 8, 229-234.
15. Groep, M. E.; Gregory, M. E.; Kershenbaum, L. S.; Bogle, I. D. L. Performance modelling and simulation of biochemical process sequences with interacting unit operations. Biotechnol. Bioeng. 2000, 67, 3, 300-311.
16. 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.
17. Petrides, D. P.; Koulouris, A.; Lagonikos, P. T. The role of process simulation in pharmaceutical process development and product commercialization. Pharm. Eng. 2002, 22 (1), 1-8.
18. 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, 727-735.
19. Pinto, J. M.; Montagna, J. M.; Vecchietti, A. R.; Iribarren, O. A.; Asenjo, J. A. Process performance models in the optimization of multiproduct protein production plants. Biotechnol. Bioeng. 2001, 74 (6), 451-465.
20. Richard, A.; Margaritis, A. Empirical modelling of batch fermentation kinetics for poly(glutamic acid) production and other microbial biopolymers. Biotechnol. Bioeng. 2004, 87 (4), 501-515.
21. Reynolds, T.; Boychyn, M.; Sanderson, T.; Bulmer, M.; More, J.; Hoare, M. Scale-down of continuous filtration for rapid bioprocess design: Recovery and dewatering of protein precipitate suspensions. Biotechnol. Bioeng. 2003, 83 (4), 454-464.
22. Clarkson, A. I.; Bulmer, M.; Titchener-Hooker, N. J. Pilot-scale verification of a computer-based simulation for the centrifugal recovery of biological particles. Bioprocess Biosyst. Eng. 1996, 14, 2, 81-89.
23. Maybury, J. P.; Mannweiler, K.; Titchener-Hooker, N. J.; Hoare, M.; Dunnill, P. The performance of a scaled down industrial disc stack centrifuge with a reduced feed material requirement. Bioprocess Eng. 1998, 18, 191-199.
24. Siddiqi, S. F.; Titchener-Hooker, N. J.; Ayazi Shamlou, P. Simulation of particle size distribution changes occurring during high-pressure disruption of bakers' yeast. Biotechnol. Bioeng. 1996, 50, 2, 145-150.
25. Wong, H. H.; O'Neill, B. K.; Middelberg, A. P. J. A mathematical model for Escherichia coli debris size reduction during high pressure homogenisation based on grinding theory. Chem. Eng. Sci. 1997, 52, 17, 2883-2890.
26. Kaczmarski, K.; Antos, D.; Sajonz, H.; Sajonz, P.; Guichon, G. Comparative modelling of breakthrough curves of bovine serum albumin in anion exchange chromatography. J. Chromatogr. A 2001, 925, 1-17.
27. Li, Z.; Gu, Y.; Gu, T. Mathematical modelling and scale-up of size exclusion chromatography. Biochem. Eng. J. 1998, 2 (2), 145-155.
28. Vunnum, S.; Gallant, S. R.; Kim, Y. J.; Cramer, S. M. Immobilised metal affinity chromatography: modelling of nonlinear multicomponent equilibrium. Chem. Eng. Sci. 1995, 50 (11), 1785-1803.
29. Bruce, L. J.; Chase, H. A. The combined use of in-bed monitoring and an adsorption model to anticipate breakthrough during expanded bed adsorption. Chem. Eng. Sci. 2002, 57, 3085-3093.
30. Zhou, Y. H.; Holwill, I. L. J.; Titchener-Hooker, N. J. A study of the use of computer simulations for the design of integrated downstream processes. Bioprocess Eng. 1997, 16, 367-374.
31. Zhou, Y. H.; Titchener-Hooker, N. J. Simulation and optimisation of integrated bioprocesses: a case study. J. Chem. Technol. Biotechnol. 1999, 74, 289-292.
32. Zhou, Y. H.; Titchener-Hooker, N. J. Visualising integrated bioprocess designs through "Windows of Operation." Biotechnol. Bioeng. 1999, 65 (5), 550-557.
33. AB antivenom. Ann. Emerg. Med. 2001, 37 (2), 196-201.
34. Porter, R. R. The hydrolysis of rabbit γ-globulin and antibodies with crystalline papain. Biochem. J. 1959, 73, 119-126.
35. McGill, T.; Klobas, J. E. The role of spreadsheet knowledge in user-developed application success. Decision Support Syst. 2004, 39 (3), 355-369.
36. Mustafa, M. A.; Washbrook, J.; Lim, A. C.; Zhou, Y.; Titchener-Hooker, N. J.; Morton, P.; Berezenko, S.; Farid, S. S. A software tool to assist business-process decision-making in the biopharmaceutical industry. Biotechnol. Prog. 2004, 20, 1096-1102.
37. Newcombe, A. R.; Cresswell, C.; Davies, S.; Watson, K.; Harris, G.; O'Donovan, K.; Francis, R. Optimised affinity purification of polyclonal antibodies from hyper immunised ovine serum using a synthetic Protein A adsorbent, MAbsorbent A2P. J. Chromatogr. B 2005, 814, 209-215.
38. Newcombe, A. R.; Cresswell, C.; Davies, S.; Pearce, F.; O'Donovan, K.; Francis, F. Evaluation of a biosensor assay to quantify polyclonal IgG in ovine serum used for the production of biotherapeutic antibody fragments. Process Biochem. 2006, 41, 842-847.