The Future of Downstream Processing - Pharmaceutical Technology

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PharmTech Europe

The Future of Downstream Processing
The author reviews the state of downstream processing and considers potential solutions, including the streamlining of full processes and borrowed technologies.


Pharmaceutical Technology
Volume 35, pp. s36-s41

References

1. U. Gottschalk, "The Renaissance in Protein Purification" supplement to Biopharm. Intl. 19, 8–9 (2006).

2. D.L. Hacker, M. De Jesus, and F.M. Wurm, Biotechnol. Adv. 27, 1023–1027 (2009).

3. A.S. Rathore and H. Winkle, Nat. Biotechnol. 27, 26–34 (2009).

4. W. Berthold, Proceedings of BioManufacturing World 2010 (Shanghai, China, 2010).

5. F.M. Wurm, Nature 22, 1393–1398 (2004).

6. S. Aldridge, GEN, 26 (1) (2006).

7. FDA, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" (Rockville, MD, August 2002).

8. FDA, "PAT Guidance for Industry: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance" (Rockville, MD, September 2004).

9. K.A. Thiel, Nat. Biotechnol 22, 1365–1372 (2004).

10. C. Sheridan, Nat. Biotechnol. 28, 307–310 (2010).

11. G. Walsh, Nat. Biotechnol. 28, 917–924 (2010).

12. U. Gottschalk, "New and Unknown Challenges Facing Biomanufacturing," supplement to BioPharm. Intl. 18 (3), 24–28 (2005).

13. S. Vunnum, G. Vedantham, and B. Hubbard (2009) "Protein A-based Affinity Chromatography," in Process Scale Purification of Antibodies, U. Gottschalk, Ed. (Wiley, NY, 2009) pp. 79–102.

14. J. Glynn et al., "The Development and Application of a Monoclonal Antibody Purification Platform," supplement to Biopharm. Intl. (2009).

15. J. Glynn et al., "Development of a MAb harvest protocol. Biochemical Engineering XV: Engineering Biology from Biomolecules to Complex Systems" (Quebec City, Canada, July 15-19 2007).

16. J. Thömmes and M. Etzel, Biotechnol. Prog. 23:42-45(2007)

17. J. Thömmes and U. Gottschalk, "Alternatives to Packed-bed Chromatography for Antibody Extraction and Purification," in Process-scale Purification of Antibodies, U. Gottschalk, Ed. (Wiley, NY, 2009) pp. 293–308.

18. A.A. Shulka and J.R. Kandula, "Harvest and recovery of monoclonal antibodies: Cell Removal and Clarification" in Process Scale Purification of Antibodies, U. Gottschalk, Ed. (Wiley, NY 2009 ) pp. 53–78.

19. R. Shpritzer et al., 232nd ACS National Meeting (San Francisco CA, 2006).

20. J. Glynn, "Process Scale Precipitation of Impurities in Mammalian Cell Culture Broth," in Process Scale Purification of Antibodies,U. Gottschalk, Ed. (Wiley, NY, 2009) pp. 309–324.

21. T. Przybycien, S. Narahari, and L. Steele, Biotechnol. 15, 469–478 (2004).

22. U. Kent, Methods in Molec. Biol. 115, 11–18 (1999).

23. M. Page and R. Thorpe, "Purification of IgG by Precipitation with Sodium Sulfate or Ammonium Sulfate," in The Protein Protocols Handbook, 2nd edition, J.M. Walker, Ed. (Humana Press, Totowa, NJ, 2002) pp. 983–984.

24. W. Lebing et al., Vox Sanguinis 84, 193–201(2003).

25. J. Parkkinen et al.,Vox Sanguinis 90, 97–104(2006).

26. V. Klyushnichenko, Curr. Opin. Drug. Disc. Dev. 6, 848–854 (2003).

27. M.X. Yang et al., Proc. Natl. Acad. Sci. USA, 100, 6934–6939. (2003).

28. J. Peters, T. Minuth, and W. Schröder, Protein Expr. Purif. 39, 43–53. (2005).

29. J. Curling and U. Gottschalk., BioPharm. Intl. 21, 70–94 (2007)

30. U. Gottschalk, Adv. Biochem. Eng. Biotechnol. 115, 171-183 (2010)

31. J.K. Walter et al., "Membrane separations," in Protein Purification: Principles, High Resolution Methods, and Applications, 3rd Edition, J.C. Janson, Ed. (Wiley, NY, in press, 2011)

32. U. Gottschalk, Biotechnol. Prog. 24, 496-503(2008).

33. J. Zhou and T. Tressel, Biotechnol. Prog. 22, 341–349(2006).

34. J. Thömmes and M.R. Kula, Biotechnol. Prog. 11, 357–367 (1995).

35. N. Fraud et al., BioPharm. Intl. 23, 24–27. (2009).

36. R. Faber, Y. Yang, and U. Gottschalk, BioPharm. Intl. 23, 11–14. (2009).

37. L. Giovannoni, M. Ventani, and U. Gottschalk, BioPharm. Intl. 23 (3) (2009).

38. S. Curtis et al., Biotechnol. Bioeng. 84, 179–186 (2003).

39. L. Norling, J. Chromatogr. 1069, 79–89 (2005).


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