Basic concepts in Q membrane chromatography for large-scale antibody production

Biotechnology Progress

Volumn 22, Issue 2, 2006, Pages 341-349

  Zhou, Joe X ^a   Tressel, Tim ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODIES; CHROMATOGRAPHIC ANALYSIS; PURIFICATION; THROUGHPUT; VIRUSES;

LARGE-SCALE ANTIBODY PRODUCTION; MEMBRANE ADSORBERS; Q MEMBRANES;

BIOLOGICAL MEMBRANES;

ANTIBODY;

ANIMAL; BIOLOGICAL MODEL; CHROMATOGRAPHY; ECONOMICS; HUMAN; ISOLATION AND PURIFICATION; METHODOLOGY; REVIEW; TEMPERATURE; TIME; VISCOSITY;

ANIMALS; ANTIBODIES; CHROMATOGRAPHY; HUMANS; MODELS, BIOLOGICAL; TEMPERATURE; TIME FACTORS; VISCOSITY;

EID: 33646041909     PISSN: 87567938     EISSN: None     Source Type: Journal    
DOI: 10.1021/bp050425v     Document Type: Review

References (58)

1. Daemmrich, A.; Browden, M. E. A rising drug industry. Chem. Eng. News 2005, June, 28-42.
2. Chadd, H. E.; Chamow, S. M. Therapeutic antibody expression technology. Curr. Opin. Biotechnol. 2001, 12, 188-194.
3. Walsh, G. Biopharraaceuticals: Approvals and approval trends in 2004. BioPharm Int. 2005, 18 (5), 58-65.
4. Li, F.; Zhou, J.; Yang, X.; Tressel, T.; Lee, B. Current therapeutic antibody production and process optimization. Bioprocess. J. 2005, 4 (5), 23-30.
5. Fahrner, R. L.; Blank, G. S. Real-time control of antibody loading during protein A affinity chromatography using an on-line assay. J. Chromatogr. A 1999, 849 (1), 191-196.
6. Fahrner, R. L.; Whitney, D. H.; Vanderlaan, M.; Blank, G. S. Performance comparison of protein A affinity-chromatography sorbents for purifying recombinant monoclonal antibodies. Biotechnol. Appl. Biochem. 1999, 30, 121-128.
7. Zhou, J.; Tressel, T.; Hong, T.; Solamo, F.; Dermawan, S. Utilize current separation technology to achieve a cost-effective robust process for recombinant monoclonal antibody production. In Antibody World Summit, 2005, July 24-27, 2005; Hyatt Regency Jersey City on the Hudson, Jersey City, NJ: http://www.srinstitute.com/conf_page.cfm?pt=/CustomerFiles_sri/agenda/ detailed_agenda.cfm&web_page_id=2301&web_id=598&instance_id= 27&pid=280&iteration_id=339.
8. Tressel, T.; Zhou, J. Process development of an anion exchange membrane. North American Membrane Society Conference, 2005, June 4-6. http://www.utoledo. edu/nams/2005/viewpaper.cfm?ID=811.
9. Fahrner, R. L. Industrial purification of pharmaceutical antibodies: Development, operation, and validation of chromatography process. Biotechnol. Genet. Eng. Rev. 2001, 18, 301-327.
10. Fish, B. Concepts in Development of Manufacturing Strategies for Monoclonal Antibodies; Plenum Publishers: New York, 2004; Vol. 1.
11. Kemp, G.; O'Neil, P. Large-Scale Production of Therapeutic Antibodies: Considerations for Optimizing Product Capture and Purification; Plenum Publishers: New York, 2004; Vol. 1.
12. Jacob, L.R.; Frech, M. Scale-Up of Antibody Purification; Plenum Publishers: New York, 2004; Vol. 1.
13. Vandevyver, C.; Freitag, R. Purification of Antibodies by Chromatographic Methods; Plenum Publishers: New York, 2004; Vol. 1.
14. Bray, J.; Brattle, K. Monoclonal Antibody Production: Minimising Virus Safety Issues; Plenum Publishers: New York, 2004; Vol. 1.
15. Darling, A. Validation of biopharmaceutical purification processes for virus clearance evaluation. Mol. Biotechnol. 2002, 21 (1), 57-83.
16. Martin, J. Case Study-Orthoggonal Membrane technologies for Viral and DNA Clearance. In SCI Membrane Chromatography Conference: http://www.sci.org/SCI/ events/membrane/Martinpdf: Nov. 3, 2004; London, UK.
17. Petsch, D.; Anspach, F. B. Endotoxin removal from protein solutions. J. Biotechnol. 2000, 76, 97-119.
18. Knudsen, H.; Fahrner, R.; Xu, Y.; Norling, L.; Blank, G. Membrane ion-exchange chromatography for process-scale antibody purification. J. Chromatogr. A 2001, 907, 145-154.
19. Yuan, Q. S.; Rosenfeld, A.; Root, T. W.; Klingenberg, D. J.; Lightfoot, E. N. Flow distribution in chromatographic columns. J. Chromatogr. A 1999, 831(2), 149-165.
20. Brandt, S.; Goffe, R. A.; Kessler, S. B.; O'Connor, J. L.; Zale, S. E. Membrane-based affinity technology for commercial scale purifications. Bio/Technology 1988, 6, 779-782.
21. Fulton, S. P.; Meys, M.; Varady, L.; Jansen, R.; Afeyan, N. B. Antibody quantitation in seconds using affinity perfusion chromatography. Biotechniques 1991, 11 (2), 226-231.
22. Fulton, S. P.; Shahidi, A. J.; Gordon, N. F.; Afeyan, N. B. Large-scale processing & high-throughput perfusion chromatography. Bio/Technology 1992, 10(6), 635-639.
23. Gottschalk, U.; Fishcher-Fruehholz, S. A cutting edge process technology at the threshold. BioProcess Int. 2004, May, 56-65.
24. Finger, U. B.; Thommes, J.; Kinzelt, D.; Kula, M. R. Application of thiophilic membranes for the purification of monoclonal antibodies from cell culture media. J. Chromatogr. B 1995, 664 (1), 69-78.
25. Frey, D. D.; Water, R. V.; Zhang, B. Dispersion in stacked-membrane chromatography. J. Chromatogr. A 1992, 603 (1-2), 43-47.
26. Charcosset, C. Purification of proteins by membrane chromatography. J. Chem. Technol. Biotechnol.y 1999, 71 (2), 95-110.
27. Roper, D. K.; Lightfoot, E. N. Separation of biomolecules using adsorptive membranes. J. Chromatogr. A 1995, 702(1-2), 3-26.
28. Lutkemeyer, D.; Bretschneider, M.; Buntemeyer, H.; Lehmann, J. Membrane chromatography for rapid purification of recombinant antithrombin III and monoclonal antibodies from cell culture supernatant. J. Chromatogr. 1993, 639 (1), 57-66.
29. Briefs, K.-G.; Kula, M.-R. Fast protein chromatography on analytical and preparative scale using modified microporous membranes. Chem. Eng. Sci. 1992, 47, 141-149.
30. Riese, U.; Lutkemeyer, D.; Heidemann, R.; Buntemeyer, H.; Lehmann, J. Re-use of spent cell culture medium in pilot scale and rapid preparative purification with membrane chromatography. J. Biotechnol. 1994, 34 (3), 247-257.
31. Finger, U. B.; Brummer, W.; Knieps, E.; Thommes, J.; Kula, M. R. Investigations on the specificity of thiophilic interaction for monoclonal antibodies of different subclasses. J. Chromatogr. B 1996, 675 (2), 197-204.
32. Charcosset, C. Fractal analysis of antigen-antibody binding kinetics: Membrane chromatography applications. J. Colloid Interface Sci. 1998, 205(2), 485-487.
33. Reif, O. W.; Freitag, R. Characterization and application of strong ion-exchange membrane adsorbers as stationary phases in high-performance liquid chromatography of proteins. J. Chromatogr. A 1993, 654 (1), 29-41.
34. Lightfoot, E. N.; Coffman, J. L.; Lode, F.; Yuan, Q. S.; Perkins, T. W.; Root, T. W. Refining the description of protein chromatography. J. Chromatogr. A 1997, 760, 139-149.
35. Sauer, P. W.; Burky, J. E.; Wesson, M. C.; Sternard, H. D.; Qu, L. A high-yielding, generic fed-batch cell culture process for production of recombinant antibodies. Biotechnol. Bioeng. 2000, 67 (5), 585-597.
36. Ghosh, R. Protein separation using membrane chromatography: opportunities and challenges. J. Chromatogr. A 2002, 952 (1-2), 13-27.
37. Specht, R.; Han, B.; Wickramasinghe, S. R.; Carlson, J. O.; Czermak, P.; Wolf, A.; Reif, O. W. Densonucleosis virus purification by ion exchange membranes. Biotechnol. Bioeng. 2004, 88 (4), 465-473.
38. Kuiper, M.; Sanches, R. M.; Walford, J. A.; Slater, N. K. Purification of a functional gene therapy vector derived from Moloney murine leukaemia virus using membrane filtration and ceramic hydroxyapatite chromatography. Biotechnol. Bioeng. 2002, 80 (4), 445-453.
39. Teeters, M. A.; Conrardy, S. E.; Thomas, B. L.; Root, T. W.; Lightfoot, E. N. Adsorptive membrane chromatography for purification of plasmid DNA. J. Chromatogr. A 2003, 989 (1), 165-173.
40. Zhang, S.; Krivosheyeva, A.; Nochumson, S. Large-scale capture and partial purification of plasmid DNA using anion-exchange membrane capsules. Biotechnol. Appl. Biochem. 2003, 37 (Pt 3), 245-249.
41. Grunwald, A. G.; Shields, M. S. Plasmid purification using membrane-based anion-exchange chromatography. Anal. Biochem 2001, 296(1), 138-141.
42. Deshmukh, R. R.; Warner, T. N.; Hutchison, F.; Murphy, M.; Leitch, W. E., 2nd.; De Leon, P.; Srivatsa, G. S.; Cole, D. L.; Sanghvi, Y. S. Large-scale purification of antisense oligonucleotides by high-performance membrane adsorber chromatography. J. Chromatogr. A 2000, 890 (1), 179-192.
43. Neidhardt, E. A.; Luther, M. A.; Recny, M. A. Rapid, two-step purification process for the preparation of pyrogen-free murine immunoglobulin G1 monoclonal antibodies. J. Chromatogr. 1992, 590, 255-261.
44. Jungbauer, A.; Unterluggauer, F.; Uhl, K.; Buchacher, A.; Steindl, F.; Pettauer, D.; Wenisch, E. Scale-up of monoclonal antibody purification using radial streaming ion exchange chromatography. Biotechnol. Bioeng. 1988, 32, 326-333.
45. Kubota, N.; Konno, Y.; Miura, S.; Saito, K.; Sugita, K. Comparison of two convection-aided protein adsorption methods using porous membranes and perfusion beads. Biotechnol Prog, 1996, 12, 869-872.
46. Gerstner, J. A.; Hamilton, R.; Cramer, S. M. Membrane chromatographic systems for high-throughput protein separations. J. Chromatogr. A 1992, 596, 173-180.
47. Gallher, P.; Fowler, E. Validation of impurity removal by the CAMPATH-1H biomanufacturing process. IBC's Biopharmaceutical Production Week: http://wwwsartoriuscom/indexphp?id=532&v=1&title=&year=&scale= &format=&membrane=&molecules= &type= 2001.
48. Norling, L.; Lute, S.; Emery, R.; Khuu, W.; Voisard, M.; Xu, Y.; Chen, Q.; Blank, G.; Brorsona, K. Impact of multiple reuse of anion-exchange chromatography media on virus removal. J. Chromatogr. 2005, 1069 (1), 79-89.
49. Pieracci, J.; Schifftner, C.; Conley, L.; Thommes, J. Membrane adsorber processes: Challenges at small scale. 2004 Annual ACS Conference: http://oasys2confexcom/acs/227nm/techprogram/ 2004.
50. Zhang, R.; Bouamama, T.; P Tabur, P.; Zapata, G. A. Q membrane chromatography application for human antibody purification process. BioProduction 2004: http://wwwabgenixcom/documents/Bioproduction2004pdf.
51. Zhang, R.; Bouamama, T.; Tabur, P.; Zapata, G.; Gottschalk, U.; Mora, J.; Reif, O. Viral clearance feasibility study with Sartobind Q membrane adsorber for human antibody purification. BioProduction 2004: http://wwwsartoriusde/en/ biotechnology/laboratory/products_applications/membrane_adsorbers/literature/ pdfs/Zhang_2004_Viral_clearance_feasabiltity_study_Sartobind_Qpdf2004.
52. Demmer, W.; Nussbaumer, D. Large-scale membrane adsorbers. J. Chromatogr. A 1999, 852 (1), 73-81.
53. Bird, R. B.; Sterwart, W. E.; Lightfoot, E. N. Transport Phenomena; Wiley: New York, 1960.
54. Tennikova, T. B.; Svec, F. High-performance membrane chromatography: Highly efficient separation method for proteins in ion-exchange, hydrophobic interaction and reversed-phase modes. J. Chromatogr. A 1993, 646, 279-288.
55. Sarfer, F. T.; Etzel, M. R. Mass transfer limitations in protein separations using ion-exchange membranes. J. Chromatogr. A 1997, 764, 3-20.
56. Yang H.; Bitzer M.; Etzel M. R. Analysis of protein purification using ion-exchange membranes. Ind. Eng. Chem. Res. 1999, 38, 4044-4050.
57. Zhou J.; Tressel T.; Solamo F.; Dermawan S.; Hong T.; Gottschalk U.; Reif O.; Pastor A.; Mora J.; Hutchison F.; Murphy, M. A new Sartobind Q scale-down model for process-scale anitbody purification. Submitted for publication.
58. Zhou, J.; Tressel, T. Q. membrane Chromatography as a robust purification unit for large-scale antibody production. Bioprocess Int. 2005, 3 (9), Suppl. 32-37.