Harvest of a therapeutic protein product from high cell density fermentation broths: Principles and case study

Process Scale Bioseparations for the Biopharmaceutical Industry

Volumn , Issue , 2006, Pages 1-58

  Russell, Elisabeth ^a   Wang, Alice ^a   Rathore, Anurag S ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85123422676     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (56)

1. Stephenne J. Production in yeast versus mammalian cells of the firstrecombinant DNA human vaccine and its proved safety, efficacy and economy: Hepatitis B vaccine. In Mizrahi A and Wezel AL van, Eds., Advances in Biotechnological Processes: Viral Vaccines, Vol. 14. New York: Alan R. Liss, 1990.
2. Belter PA, Cussler EL, and Hu WS. Bioseparations: Downstream Processing for Biotechnology. New York: John Wiley & Sons, Inc., 1988.
3. Sharma BP. Cell separation systems. In Lydersen B, D'Elia N, and Nelson K, Eds., Bioprocess Engineering: System, Equipment and Facilities. New York: John Wiley & Sons, Inc., 1994, pp. 87-117.
4. Bentham AC, Bonnerjea J, Orsborn CB, Ward PN, and Hoare M. The separation of affinity flocculated yeast cell debris using pilot-plant scroll decanter centrifuge. Biotechnology and Bioengineering 1990; 36: 397-401.
5. Mosqueira FG, Higgins JJ, Dunnill P, and Lilly MD. Characteristics of mechanically disrupted baker's yeast in relation to its separation in industrial centrifuges. Biotechnology and Bioengineering 1981; 23: 335-343.
6. Clarkson AI, Bulmer M, and Titchener-Hooker NJ. Pilot-scale verification of a computer-based simulation for the centrifugal recovery of biological particles. Bioprocess Engineering 1996; 14: 81-89.
7. Varga EG, Titchener-Hooker NJ, and Dunnill P. Prediction of the pilot-scale recovery of a recombinant yeast enzyme using integrated models. Biotechnology and Bioengineering 2001; 74: 96-107.
8. Yavorsky D, Blanck R, Lambalot C, and Brunkow R. The clarification of biore-actor cell cultures for biopharmaceuticals. Pharmaceutical Technology 2003; 62-76.
9. van Reis R and Zydney A. Membrane separations in biotechnology. Current Opinion in Biotechnology 2001; 12: 208-211.
10. Yavorsky D and Mcgee S. Selection and sizing of clarification depth filters. Genetic Engineering News 2002; 22: 44-45.
11. Bell DJ and Davies RJ. Cell harvesting of oleaginous yeast by crossflow filtration. Biotechnology and Bioengineering 1987; 29: 1176-1178.
12. Rathore AS, Wang A, Menon M, Riske F, Campbell J, Goodrich E, and Martin J. Optimization, scale-up and validation issues in filtration of biopharmaceuticals - part I. Biopharm International 2004; 17(8): 50-58.
13. Heertjes PM and Zuideveld PL. Clarification of liquids using filter aids Part I. Mechanisms of filtration. Powder Technology 1978; 19: 17-30.
14. Heertjes PM and Zuideveld PL. Clarification of liquids using filter aids Part II. Depth filtration. Powder Technology 1978; 19: 31-43.
15. Theodossiou I, Collins IJ, Ward JM, Thomas ORT, and Dunnill P. The processing of a plasmid-based gene from E. coli primary recovery by filtration. Bioprocess Engineering 1997; 16: 175-183.
16. da Matta VM and Medronho RA. A new method for yeast recovery in batch ethanol fermentations: Filter aid filtration followed by separation of yeast from filter aid using hydrocyclones. Bioseparation 2000; 9: 43-53.
17. Reynolds T, Boychyn M, Sanderson T, Bulmer M, More J, and Hoare M. Scale-down of continuous filtration for rapid bioprocess design: Recovery and dewatering of protein precipitate suspensions. Biotechnology and Bioengineering 2003; 83: 454-464.
18. Dynamic depth-filtration: Proof of principle. Technical note AMC06 v. 3.1, Advanced Minerals Corporation, 2004.
19. Russotti G and Goklen KE. Crossflow membrane filtration of fermentation broth. In William K Wang, Ed., Membrane Separations in Biotechnology.New York: Marcel Dekker, 2001, pp. 85-160.
20. Schlegel VL and Meagher M. Effects of different membrane modular systems on the performance of crossflow filtration of Pichia pastoris suspensions. In William K Wang, Ed., Membrane Separations in Biotechnology. New York: Marcel Dekker, 2001, pp. 189-204.
21. Patel PN, Mehaia MA, and Cheryan M. Crossflow membrane filtration of yeast suspensions. Journal of Biotechnology 1987; 5: 1-16.
22. Sheehan JJ, Hamilton BK, and Levy PF. Pilot-scale membrane filtration process for the recovery of an extracellular bacterial protease. ACS Symposium, Series 419, 1988, pp. 130-155.
23. van Reis R, Leonard L, Hsu C, and Builder S. Industry scale harvest of protein from mammalian cell culture by tangential flow filtration. Biotechnology and Bioengineering 1991; 38: 413-422.
24. Redkar SG and Davis RH. Crossflow microfiltration of yeast suspensions in tubular filters. Biotechnology Progress 1993; 9: 625-634.
25. Tanaka T, Kamimura R, Itoh K, and Nakanishi K. Factors affecting the performance of crossflow filtration of yeast cell suspension. Biotechnology and Bioengineering 1992; 41: 617-624.
26. Russotti G, Osawa AE, Sitrin RD, Buckland BC, Adams WR, and Lee SS. Pilot plant harvest of recombinant yeast employing microfiltration: A case study. Journal of Biotechnology 1995; 42: 235-246.
27. Bailey SM and Meagher MM. Crossflow microfiltration of recombinant Escherichia coli lysates after high pressure homogenization. Biotechnology and Bioengineering 1997; 56: 304-310.
28. Jacob J, Prádanos P, Calvo JI, Hernández A, and Jonsson G. Fouling kinetics and associated dynamics of structural modifications. Colloids and Surfaces A: Physicochemical and Engineering Aspects 1998; 138: 173-183.
29. Kwon DY, Vigneswaran S, Fane AG, and Ben AR. Experimental determination of critical flux in crossflow microfiltration. Separation Purification Technology 2000; 19: 169-181.
30. Lee SS, Burt A, Russotti G, and Buckland B. Microfiltration of recombinant yeast cells using a rotating disk dynamic filtration system. Biotechnology and Bioengineering 1995; 48: 386-400.
31. Frenaander U and Jonsson A. Cell harvesting by cross-flow microfiltration using a shear-enhanced module. Biotechnology and Bioengineering 1996; 52: 397-403.
32. Parnham CD and Davis RH. Protein recovery from cell debris using rotary and tangential cross-flow microfiltration. Biotechnology and Bioengineering 1995; 47: 155-164.
33. Schutyser M, Rupp R, Wideman J, and Belfort G. Dean vortex membrane microfiltration and diafiltration of rBNDF E. coli inclusion bodies. Biotechnology Progress 2002; 18: 322-329.
34. Luque S, Mallubhotla H, Gehlert G, Kuriyel R, Dzengeleski S, Pearl S, and Belfort G. A new coiled hollow-fiber module design for enhanced microfiltration performance in biotechnology. Biotechnology and Bioengineering 1999; 65: 247-257.
35. Davis RH. Crossflow microfiltration with back pulsing. In William K Wang, Ed., Membrane Separations in Biotechnology. New York: Marcel Dekker, 2001, pp. 161-188.
36. Anspach FB, Curbelo D, Hartmann R, Garke G, and Deckwer W. Expanded bed chromatography in primary protein purification. Journal of Chromatography A 1999; 865: 129-144.
37. Hjorth R. Expanded-bed adsorption in industrial bioprocessing: Recent developments. TIBTECH 1997; 15: 230-235.
38. Lyddiatt A. Process chromatography: Current constraints and future options for the adsorptive recovery of bioproducts. Current Opinion in Biotechnology 2002; 13: 95-103.
39. Noda M, Sumi A, Ohmura T, and Yokoyama K. European patent application EP0699687A2.
40. Trinh L, Noronha S, Fannon M, and Shiloach J. Recovery of mouse endostatin produced by Pichia pastoris using expanded bed adsorption. Bioseparation 2000; 9: 223-230.
41. Russell E. Evaluation of disc stack centrifugation for the clarification of mammalian cell culture. M.S. thesis 2003, Tufts University.
42. Ambler C. The evaluation of centrifuge performance. Chemical Engineering Process 1952; 48: 150-158.
43. Maybury JP, Hoare M, and Dunnill P. The use of laboratory centrifugation studies to predict performance of industrial machines: Studies of shear-insensitive and shear-sensitive materials. Biotechnology and Bioengineering 2000; 67: 265-270.
44. Kempken R, Preissmann A, and Berthold W. Assessment of a disc stack centrifuge for the use in mammalian cell separation. Biotechnology and Bioengineering 1994; 46: 132-138.
45. Kubitschek H. Buoyant density variation during cell cycle in microorganisms. Critical Reviews in Microbiology 1987; 14: 73-97.
46. Belfort G. Membrane separation technology: An overview. In Bungay HR and Belfort G, Eds., Advanced Biochemical Engineering. Chapter 8, New York: Wiley, 1987, pp. 187-217.
47. Atkinson B and Mavituna F. Biochemical Engineering and Biotechnology Handbook. New York: Stockton Press, 1991, pp. 957-959.
48. Perry R. Perry's Chemical Engineers' Handbook, 6th ed. New York: McGraw-Hill, Inc., 1984, pp. 19-66.
49. Smith G. Filter aid filtration. In Filtration in the Biopharmaceutical Industry. New York: Marcel Dekker, Inc., 1998.
50. Gadam S, Leong A, Lee A, and Kosinski M. Clarification of yeast lysate using diatomaceous earth. Presented at the recovery of Biological Products 10, Cancun, Mexico, June 3-8, 2001.
51. Hunt, T. Filter aids. In Encyclopedia of Bioprocess Technology: Fermentation, Biocatalysis and Bioseparation. New York: John Wiley & Sons, 1999.
52. Cheryan M. Performance and Engineering Models: Ultrafiltration and Microfiltration Handbook. Lancaster: Technomic, Inc., 1998, p. 133.
53. Belfort G, Davis R, and Zyndey A. The behavior of suspensions and macro-molecular solutions in crossflow microfiltration. Journal of Membrane Science 1996; 96: 1-58.
54. Zydney A and Colton C. A concentration polarization model for the filtrate flux in crossflow microfiltration of particulate suspensions. Chemical Engineering Communication 1987; 47: 275-281.
55. Zeman L and Zyndey A. Microfiltration and Ultrafiltration, Principles and Applications. New York: Marcel Dekker, Inc., 1996.
56. Wang A, Lewus R, and Rathore A. Comparison of different options for harvest of a therapeutic protein product from high cell density yeast fermentation broth. Biotechnology and Bioengineering, in print, 2006.