Design strategies for integrated protein purification processes: Challenges, progress and outlook

Journal of Chemical Technology and Biotechnology

Volumn 83, Issue 2, 2008, Pages 124-132

  Nfor, Beckley K ^a   Ahamed, Tangir ^a   van Dedem, Gijs W K ^a   van der Wielen, Luuk A M ^a   van de Sandt, Emile J A X ^b   Eppink, Michel H M ^c   Ottens, Marcel ^a  

^a DELFT UNIVERSITY OF TECHNOLOGY   (Netherlands)

^b DSM RESOLVE   (Netherlands)

^c NV ORGANON   (Netherlands)

Author keywords

Algorithmic approach; Expert systems; High throughput experimentation; Process development; Process synthesis; Protein purification

Indexed keywords

ALGORITHMS; EXPERT SYSTEMS; PURIFICATION; SYNTHESIS (CHEMICAL);

HIGH THROUGHPUT EXPERIMENTATION; PROCESS DEVELOPMENT; PROCESS SYNTHESIS; PROTEIN PURIFICATION;

PROTEINS;

DRUG; ENZYME; FOOD ADDITIVE; NUTRACEUTICAL;

ALGORITHMS; EXPERT SYSTEMS; PROTEINS; PURIFICATION; SYNTHESIS (CHEMICAL);

ADSORPTION; AFFINITY CHROMATOGRAPHY; CRYSTALLIZATION; DIAFILTRATION; DISTILLATION; DRUG INDUSTRY; DRUG RESEARCH; ELECTRODIALYSIS; EVAPORATION; EXTRACTION; FOOD AND DRUG ADMINISTRATION; GEL PERMEATION CHROMATOGRAPHY; HIGH THROUGHPUT SCREENING; ION EXCHANGE CHROMATOGRAPHY; METHODOLOGY; PRECIPITATION; PROCESS OPTIMIZATION; PROTEIN ISOLATION; PROTEIN PURIFICATION; REVERSE OSMOSIS; REVIEW; ULTRAFILTRATION; UNITED STATES;

EID: 38849183340     PISSN: 02682575     EISSN: 10974660     Source Type: Journal    
DOI: 10.1002/jctb.1815     Document Type: Review

References (72)

1. Pavlou AK and Reichert JM, Recombinant protein therapeutics-success rates, market trends and values to 2010. Nat Biotechnol 22:1513-1519 (2004).
2. BioPortfolio Limited, Biopharmaceuticals Current Market Dynamics & Future Outlook. BioPortfolio Limited, Frampton, UK (2005).
3. Headon DR and Walsh G, The industrial production of enzymes. Biotechnol Adv 12:635-646 (1994).
4. Walsh G, Biopharmaceutical benchmarks. Nat Biotech 18:831-833 (2000).
5. Smith C, Striving for purity: advances in protein purification. Nat Meth 2:71-77 (2005).
6. Thiel KA, Biomanufacturing, from bust to boom... to bubble? Nat Biotech 22:1365-1372 (2004).
7. Lighffoot EN and Moscariello JS, Bioseparations. Biotechnol Bioeng 87:259-273 (2004).
8. Hodge G, Investing in Process Development. wwwbioprocessingjournalcom (2004).
9. FDA, Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. US Food and Drug Administration (2004).
10. Bensch M, Wierling PS, Lieres Ev and Hubbuch J, High throughput screening of chromatographic phases for rapid process development. Chem Eng Technol 28:1274-1284 (2005).
11. Rege K, Pepsin M, Falcon B, Steele L and Heng M, High-throughput process development for recombinant protein purification. Biotechnol Bioeng 93:618-630 (2006).
12. Gosling I, Process simulation and modeling for industrial bioprocessing: Tools and techniques. Ind Biotechnol 1:106-109 (2005).
13. Petrides DP, Koulouris A and Lagonikos PT, The role of process simulation in pharmaceutical process development and product commercialization. Pharmaceutical Eng 22:1-8 (2002).
14. Lu Y, Clarkson A, Titchener-Hooker N, Pantelides C and Bogle D, Simulation as a tool in process design and management for production of intracellular enzymes. IChemE Symposium Series 133:183-189 (1994).
15. Petrides DP, BioPro Designer: An advanced computing environment for modeling and design of integrated biochemical processes. Comput Chem Eng 18:S621-S625 (1994).
16. FDA, Guidance for Industry PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. US Food and Drug Administration (2004).
17. Barnicki SD and Siirola JJ, Process synthesis prospective. Comput Chem Eng 28:441-446 (2004).
18. Naonori Nishida GS and Westerberg AW, A review of process synthesis. AIChE J 27:(1981).
19. Westerberg AW, A retrospective on design and process synthesis. Comput Chem Eng 28:447-458 (2004).
20. Petrides DP, Cooney CL and Evans LB, Biochemical process design, in Chemical Engineering Problems in Biotechnology. American Institute of Chemical Engineers (1989).
21. Petrides D, Bioprocess design and economics, in Bioseparations Science and Engineering, ed. by Harrison RG. Oxford University Press, New York (2003).
22. Leser EW and Asenjo JA, Rational design of purification processes for recombinant proteins. J Chromatogr 584:43-57 (1992).
23. Wai PPC, Bogle IDL, Bagherpour K and Gani R, Process synthesis and simulation strategies for integrated biochemical process design. Comput Chem Eng 20:S357-S362 (1996).
24. Harrison RG, Bioseparations Science and Engineering. Oxford University Press, New York (2003).
25. Asenjo JA, Separation Processes in Biotechnology. Marcel Dekker, New York (1990).
26. Asenjo JA and Patrick I, Large-scale protein purification, in Protein Purification Applications a Practical Approach, ed. by Harris ELV and Angal S. Oxford University Press, Oxford, pp. 1-28 (1990).
27. Hubbuch J and Kula M-R, Isolation and purification of biotechnological products. J Non-Equilib Thermodyn 32:99-127 (2007).
28. Freydell EJ, Ottens M, Eppink M, Dedem Gv and Wielen Lvd, Efficient solubilization of inclusion bodies. Biotechnol J 2:678-684 (2007).
29. Choe W-S, Nian R and Lai W-B, Recent advances in biomolecular process intensification. Chem Eng Sci 61:886-906 (2006).
30. Cabrita LD and Bottomley SP, Protein expression and refolding - a practical guide to getting the most out of inclusion bodies. Biotechnol Annu Rev 10:31-50 (2004).
31. De Bernardez Clark E, Refolding of recombinant proteins. Curr Opin Biotechnol 9:157-163 (1998).
32. Przybycien TM, Pujar NS and Steele LM, Alternative bioseparation operations: life beyond packed-bed chromatography. Curr Opin Biotechnol 15:469-478 (2004).
33. Thommes J and Etzel M, Alternatives to chromatographic separations. Biotechnol Prog 23:42-45 (2007).
34. Kelner DN, Wang W and Wang DQ, Protein formulation. Biotechnol Bioprocess 27:549-604 (2003).
35. Sellers SP and Maa Y-F, Principles of biopharmaceutical protein formulation: an overview. Methods Mol Biol 308:243-263 (2005).
36. Ghosh R, Protein bioseparation: an overview, in Protein Bioseparation Using Ultrafiltration: Theory, Applications and New Developments. Imperial College Press, London (2003).
37. Sofer G and Hagel L, Purification design, optimization, and scale-up, in Handbook of Process Chromatography: A Guide to Optimization, Scale-up, and Validation, ed. by Sofer G and Hagel L. Academic Press, London, pp. 27-113 (1997).
38. Asenjo JA, Herrera L and Byrne B, Development of an expert system for selection and synthesis of protein purification processes. J Biotechnol 11:275-298 (1989).
39. Lienqueo ME and Asenjo JA, Use of expert systems for the synthesis of downstream protein processes. Comput Chem Eng 24:2339-2350 (2000).
40. Andrews AT, Noble I, Keeratipibul S and Asenjo JA, physico-chemical properties of the matrix proteins of three main culture vehicles. Biotechnol Bioeng 44:29-37 (1994).
41. Leser EW and Asenjo JA, The rational selection of purification processes for proteins: an expert system for downstream processing design. Ann New York Academy Sci 721:337-347 (1994).
42. Asenjo JA and Andrews BA, Is there a rational method to purify proteins? From expert systems to proteomics. J Mol Recognit 17:236-247 (2004).
43. Watanabe E, Tsoka S and Asenjo JA, Selection of chromatographic protein purification operations based on physicochemical properties. Ann New York Academy Sci 721:348-364 (1994).
44. Lienqueo ME, Leser EW and Asenjo JA, An expert system for the selection and synthesis of multistep protein separation processes. Comput Chem Eng 20:S189-S194 (1996).
45. Protein Purification Handbook. GE Healthcare Life Sciences http://www5gelifesciencescom/aptrix/upp01077nsf/Content/orderonline handbooks.
46. Grossmann IE and Kravanja Z, Mixed-integer nonlinear programming techniques for process systems engineering. Comput Chem Eng 19:S189-S204 (1995).
47. Viswanathan J and Grossmann IE, A combined penalty function and outer-approximation method for MINLP optimization. Comput Chem Eng 14:769-782 (1990).
48. Lee S and Grossmann IE, New algorithms for nonlinear generalized disjunctive programming. Comput Chem Eng 24:2125-2141 (2000).
49. Yeomans H and Grossmann IE, A systematic modeling framework of superstructure optimization in process synthesis. Comput Chem Eng 23:709-731 (1999).
50. Samsatli NJ and Shah N, Optimal integrated design of biochemical processes. Comput Chem Eng 20:S315-S320 (1996).
51. Samsatli NJ and Shah N, Integrated bioprocess design. IChemE Research Event/Second European Conference for Young Researchers, 118-120 (1996).
52. Samsatli NJ and Shah N, An optimization based design procedure for biochemical processes Part I: Preliminary design anal operation. Trans IGhemE 74:221-231 (1996).
53. Samsatli NJ and Shah N, An optimization based design procedure for biochemical processes Part II: Detailed scheduling. Trans IChemE 74:232-242 (1996).
54. Zhou YH and Titchener-Hooker NJ, The use of windows of operation as a bioprocess design tool. Bioprocess Eng 14:263-268 (1996).
55. Zhou YH, Holwill ILJ and Titchener-Hooker NJ, A study of the use of computer simulations for the design of integrated downstream processes. Bioprocess Eng 16:367-374 (1997).
56. Zhou YH and Titchener-Hooker NJ, visualizing integrated bioprocess design through "windows of operation". Biotechnol Bioeng 65:550-557 (1999).
57. Zhou YH and Titchener-Hooker NJ, The application of a Pareto optimisation method in the design of an integrated bioprocess. Bioprocess Biosyst Eng 25:349-355 (2003).
58. Zhou YH and Titcherner-Hooker NJ, Simulation and optimisation of integrated bioprocesses: a case study. J Chem Technol Biotechnol 74:289-292 (1999).
59. Asenjo JA, Montagna JM, Vecchietti AR, Iribarren OA and Pinto JM, Strategies for the simultaneous optimization of the structure and the process variables of a protein production plant. Comput Chem Eng 24:2277-2290 (2000).
60. Steffens MA, Fraga ES and Bogle IDL, Synthesis of bioprocesses using physical properties data. Biotechnol Bioeng 68:218-230 (2000).
61. Vasquez-Alvarez E and Pinto JM, Efficient MILP formulations for the optimal synthesis of chromatographic protein purification processes. J Biotechnol 110:295-311 (2004).
62. Stein A and Kiesewetter A, Cation exchange chromatography in antibody purification: pH screening for optimised binding and HCP removal. J Chromatogr B 848:151-158 (2007).
63. Rege K, Ladiwala A and Cramer SM, Multidimensional high-throughput screening of displacers. Anal Chem 77:6818-6827 (2005).
64. Bensch M, Selbach B and Hubbuch J, High throughput screening techniques in downstream processing: preparation, characterization and optimization of aqueous two-phase systems. Chem Eng Sci 62:2011-2021 (2007).
65. Coffman JL and Kelley B, High-throughput screening in downstream process development of protein therapeutics. Paper presented at the 229th ACS National Meeting Division of Biochemical Technology, San Diego, CA, USA (2005).
66. Guerrier L, Lomas L and Boschetti E, A new general approach to purify proteins from complex mixtures. J Chromatogr 1156:188-195 (2007).
67. Londo T, Lynch P, Kehoe T, Meys M and Gordon N, Accelerated recombinant protein purification process development: automated, robotics-based integration of chromatographic purification and analysis. J Chromatogr 798:73-82 (1998).
68. Ahamed T, Ottens M, Nfor BK, van Dedem GWK and van der Wielen LAM, A generalized approach to thermodynamic properties of biomolecules for use in bioseparation process design. Fluid Phase Equilib 241:268-282 (2006).
69. Ahamed T, Nfor BK, Verhaert PDEM, van Dedem GWK, van der Wielen LAM, Eppink MHM, et al., pH-gradient ion-exchange chromatography: an analytical tool for design and optimization of protein separations. J Chromatogr 1164:181-188 (2007).
70. Hedhammar M, Graslund T and Hober S, Protein engineering strategies for selective protein purification, Chem Eng Technol 28:1315-1325 (2005).
71. Blanch HW, Prausnitz JM, Curtis RA and Bratko D, Molecular thermodynamics and bioprocessing: from intracellular events to bioseparations. Fluid Phase Equilib 194-197:31-41 (2002).
72. Prausnitz JM, Molecular thermodynamics for some applications in biotechnology. J Chem Thermodynam 35:21-39 (2003).