Harvest and Recovery of Monoclonal Antibodies: Cell Removal and Clarification

Process Scale Purification of Antibodies

Volumn , Issue , 2008, Pages 53-78

  Shukla, Abhinav A ^a   Kandula, Jagannadha Rao ^a  

^a BRISTOL MYERS SQUIBB COMPANY   (United States)

Author keywords

Depth filter operation and removing particulates; Harvest and recovery of monoclonal antibodies; MAb harvest and expanded bed adsorption (EBA) chromatography

Indexed keywords

EID: 84890713207     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470444894.ch3     Document Type: Chapter

References (52)

1. Walsh, G. (2004). Modern antibody based therapeutics. Biopharm 2,18-25.
2. Gottschalk, U. (2005). Downstream processing of monoclonal antibodies: From high dilution to high purity. BioPharm International 18,1-11.
3. Van Dijk, M.A., van de Winkel, G.J. (2001). Human antibodies as next generation therapeutics. Current Opinion in Chemical Biology 5, 368-374.
4. Kohler, G., Milstein, C. (1975). Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 256,495-97.
5. Hu, W.S., Piret, J.M. (1992). Mammalian cell culture processes. Current Opinion in Biotechnology 3,110-114.
6. Chu, L., Robinson, D. (2001). Industrial choices for protein production by large - scale cell culture. Current Opinion in Biotechnology 12,180-187.
7. Chadd, S.E., Chamow, S.M. (2001). Therapeutic antibody expression technology. Current Opinion in Biotechnology 12,188-194.
8. Jefferis, R. (2005). Glycosylation of recombinant antibody therapeutics: Relevance to therapeutic applications. Biotechnology Progress 21,11-16.
9. Zhang, C., van Cott, K.E. (2007). Product recovery from transgenic sources. In Shukla, A.A., Etzel, M.R., Gadam, S. (eds.) Process Scale Bioseparations for the Biopharmaceutical Industry, CRC Press, Boca Raton, FL, pp. 367-389.
10. Mazor, Y., Van Blarcom, T., Mabry, R., Iverson, B.L., Georgiou, G. (2007). Isolation of engineered, full-length antibodies from libraries expressed in Escherichia coli. Nature Biotechnology 25, 563-565.
11. Shukla, A., Hubbard, B., Tressel, T., Guhan, S., Low, D. (2007). Downstream process ing of monoclonal antibodies- Application of platform approaches. Journal of Chromatography B 848, 28-39.
12. Russell, E., Wang, A., Rathore, A.S. (2007). Harvest of a therapeutic protein product . In Shukla, A.A., Etzel, M.R., Gadam, S. (eds) Process Scale Bioseparations for the Biopharmaceutical Industry, CRC Press, Boca Raton, FL, pp. 1-58.
13. Belter, P.A., Cussler, E.L., Hu, W.S. (1988). Bioseparations: Downstream Processing for Biotechnology. John Wiley & Sons Inc., New York, NY.
14. Ambler, C. (1952) The evaluation of centrifuge performance. Chemical Engineering Progress 48,150-158.
15. Maybury, IP, Hoare, M., Dunnill, P. (2000). The use of laboratory centrifugation studies to predict performance of industrial machines: Studies of shear insensitive and shear sensitive materials. Biotechnology and Bioengineering 67, 265-273.
16. Hutchinson, N., Bingham, N., Murrell, N., Farid, S., Hoare, M. (2006). Shear stress analysis of mammalian cell suspensions for prediction of industrial centrifugation and its verification. Biotechnology and Bioengineering 95, 483-91.
17. Maybury, J.P., Mannweiler, K., Tichener-Hooker, N.J., Hoare, M., Dunill, P. (1998). The performance of a scaled -down industrial disk stack centrifuge with a reduced feed material requirement. Bioprocess Engineering 18,191-199.
18. Zhao, X., Zhou, J. (2007). Effect of solid ejection size on continuous centrifugation during mammalian cell culture product recovery. Presentation at ACS National Meeting, Boston, MA, 2007.
19. Berthhold, W., Kemken, R. (1994) Interaction of cell culture with downstream purification: A case study. Cytotechnology 15, 229-242.
20. Van Reis, R., Leonard, L.C., Hsu, C.C., Builder, S. (1991). Industrial scale harvest of proteins from mammalian cell culture by tangential fl ow filtration. Biotechnology and Bio engineering 38, 413-22.
21. Russotti, G., Goklen, K. (2001). Crossfl ow membrane filtration of fermentation broth. In Wang, W.K. (ed) Membrane Separations in Biotechnology, Marcel Dekker, New York, NY, pp. 85-159.
22. Van Reis, R., Zydney, A. Membrane separations in biotechnology. Current Opinion in Biotechnology 12, 208-211.
23. Lee, S.S., Burt, A., Russotti, G., Buckland, B. (1995). Microfiltration of recombinant yeast cells using a rotating disk dynamic filtration system. Biotechnology and Bioengineering 48, 386-00.
24. Parnham, C.S., Davis, R.H. (1995). Protein recovery from cell debris using rotary and tangential cross -fl ow microfiltration. Biotechnology and Bioengineering 47, 155-164.
25. Luque, S., Mallubhotla, H., Gehlert, G., Kuriyel, R., Dzengelski, S., Pearl, S., Belfort, G. (1999). A new coiled hollow fiber module design for enhanced microfiltration performance in biotechnology. Biotechnology and Bioengineering 63, 247-257.
26. Davis, R. (2001) Crossfl ow microfiltration with backpulsing. In Wang, W.K. (ed) Membrane Separations in Biotechnology, Marcel Dekker, New York, NY, pp. 161-188.
27. Belfort, G., Davis, R., Zydney, A. (1994). The behavior of suspensions and macro- molecular solutions in crossfl ow microfiltration. Journal of Membrane Science 96, 1-58.
28. Nagata, N., Herouvis, K., Dziewulski, D., Belfort, G. (1989). Cross-fl ow membrane microfiltration of a bacterial fermentation broth. Biotechnology and Bioengineering 34, 447-66.
29. Zydney, A., Colton, C. (1987). A concentration polarization model for the filtrate fl ux in crossfl ow microfiltration of particulate suspensions. Chemical Engineering Communications 47, 275-281.
30. Riesmeier, B., Kroner, K., Kula, M. (1989).Tangential filtration of microbial suspen sions: Filtration resistances and model development. Journal of Biotechnology 12, 153-172.
31. Fiore, IV, Olson, W.P., Holst, S.L. (1980). Depth filtration. In Curling, J.M. (ed) Methods of Plasma Protein Fractionation, Academic Press, New York, NY, pp. 239-268.
32. Singhvi, R., Schorr, C., O'Hara, C., Xie, L., Wang, D. (1996) Clarification of animal cell culture process fl uids using depth microfiltration. Biopharm 4, 35-41.
33. Badmington, F. (1998) Prefiltration technology. In Meltzer, T., Jornitz, M. (eds) Fil tration in the Biopharmaceutical Industry, Marcel Dekker, New York, NY, pp. 783-817.
34. Van Reis, R., Zydney, A. (2007). Bioprocess membrane technology. Journal of Membrane Science 297, 16-50.
35. Smith, G. (1998). Filter aid filtration. In Meltzer, T., Jornitz, M. (eds) Filtration in the Biopharmaceutical Industry, Marcel Dekker, New York, NY, pp. 1-69.
36. Knight, R., Ostreicher, E. (1998). Charge-modified filter media. In Meltzer, T., Jornitz, M. (eds) Filtration in the Biopharmaceutical Industry, Marcel Dekker, New York, NY. pp. 95-125.
37. Gerba, C., Hou, K. (1985). Endotoxin removal by charge -modified filters. Applied and Environmental Microbiology 50,1375-1377.
38. Hou, K., Gerba, C., Goyal, S., Zerda, K. (1980). Capture of latex beads, bacteria, endotoxin and viruses by charge -modified filters. Applied and Environmental Microbiology 40, 892-896.
39. Dorsey, N., Eschrich, J., Cyr, G. (1997). The role of charge in the retention of DNA by charged cellulose based depth filters. Biopharm 1,46-9.
40. Charlton, H.R., Relton, J.M., Slater, N.G. (1999). Characterization of a generic monoclonal antibody harvesting system for adsorption of DNA by depth filters and various membranes. Bioseparation 8, 281-291.
41. Tipton, B., Boose, J.A., Larsen, W., Beck, J., O'Brien, T. (2002). Retrovirus and par- vovirus clearance from an affinity column product using adsorptive depth filtration. Biopharm 1, 43-50.
42. Yigzaw Y., Tranh M., Piper R., Shukla A. (2006). Exploitation of the adsorptive properties of depth filters for host cell protein removal during monoclonal antibody purification. Biotechnology Progress 22, 288-296.
43. Yavorsky, D., Blanck, R., Lambalot, C., Brunkow, R. (2003). The clarification of bioreactor cell cultures for biopharmaceuticals. Pharmaceutical Technology, 62-74.
44. Nawrocki, J. (1997).The silanol group and its role in liquid chromatography. Journal of Chromatography A 779, 29-71.
45. Riske, F., Schroeder, J., Belliveau, I, Kang, X., Kutzko, J., Menon, M. (2007). The use of chitosan as a fl occulant in mammalian cell culture dramatically improves clarification throughput without adversely affecting monoclonal antibody recovery. Journal of Biotechnology 128, 813-823.
46. Coffman, J. (2006). Flocculation of antibody -producing mammalian cells with pre cipitating solutions of soluble cations and anions. Presentation at the International Conference on Recovery of Biological Products XII, Arizona, 2006.
47. max testing for practical microfiltration train scale -up in biopharmaceutical processing. BioPharm Interna tional 8, 46-52.
48. Anspach,F., Curbelo,D.,Hartmann,R., Garke,G.,Deckwer,W.D. (1999). Expanded- bed chromatography in primary protein purification. Journal of Chromatography A 865,129-144.
49. Hjorth, R. (1997). Expanded-bed adsorption in industrial bioprocessing: Recent developments. Trends in Biotechnology 15, 230-235.
50. Thommes, I, Bader, A., Halfar, M., Karau, A., Kula, M. (1996). Isolation of mAbs from cell containing hybridoma broth using Protein A coated adsorbent in expanded beds. Journal of Chromatography A 153,111-122.
51. Sonnenfeld, A., Thommes, J. (2007). Expanded bed adsorption for capture from crude solution. In Shukla, A.A., Etzel, M.R., Gadam, S. (eds) Process Scale Biosepa- rations for the Biopharmaceutical Industry, CRC Press, Boca Raton, FL, pp. 59-81.
52. Wang, A., Lewus, R., Rathore, A. (2006). Comparison of different options for harvest of a therapeutic protein product from high cell density yeast fermentation broth. Biotechnology and Bioengineering 94, 91-104.