A Risk-Based Approach to Transferring a Mature Biopharmaceutical Process - The authors present risk-evaluation and mitigation strategies for transfer of the manufacturing process of a recombinant gly

ADVERTISEMENT

A Risk-Based Approach to Transferring a Mature Biopharmaceutical Process
The authors present risk-evaluation and mitigation strategies for transfer of the manufacturing process of a recombinant glycoprotein.


BioPharm International
Volume 25, Issue 2, pp. 41-49

CONCLUSIONS

As demonstrated in this case study, taking a structured, documented, and disciplined approach to process transfers is crucial to the success of a transfer. While some process changes are inevitable due to facility fit reasons or differences in operational practices, it is important to avoid introducing unnecessary process changes as part of the transfer. Applying the quality risk-management concept in the process-transfer strategy ensures that the potential risk from each potential change is analyzed rigorously and the risk-mitigation and control measures are commensurate with the risks. With the proper use of both scale-down models and full-scale engineering runs, the chance of surprises during the qualification campaign can be greatly reduced.

ACKNOWLEDGMENTS

The authors gratefully acknowledge Eric Ordonez, Tom Lecocq, Mark Iversen, Shirin Fuller, Sean Forestell, Raymond Arnold, Robert Kiss, and Harry Lam for their valuable technical contributions and critical review. We also thank Boehringer Ingelheim Pharma GmbH & Co. KG for their collaboration on the work presented in this article.

Jean Harms* is a technical manager in quality operations, and Purav Dave is an engineer II in global biologics manufacturing science and technology, both at Genentech, a member of the Roche Group. *To whom correspondance should be addressed,
.

REFERENCES

1. K. Carswell, presentation at the IBC 24th International Conference, (San Diego, CA, 2009).

2. A. Mire-Sluis et al., BioProcess Int. 8 (3), 20–32 (2010).

3. F. Li et al., Biotechnol. Prog. 22 (3), 696– 703 (2006).

4. M. Winkler, "Problems in Fermenter Design and Operation," in Chemical Engineering Problems in Biotechnology, M. Winkler Ed, (Elsevier Science 1990), pp. 222–350.

5. S. Mostafa and X. Gu, Biotechnol. Prog. 19 (1), 45–51 (2003).

6. K. van't Riet, Trends in Biotechnol. 1, 113–119 (1983).

7. V. DeZengotita, A. Schmelzer, and W. Miller, Biotechnol. Bioeng. 77 (4), 369–380 (2002).

8. M. Zhu et al., Biotechnol. Prog. 21 (1), 70–77 (2005).

9. R. Kimura and W. Miller, Biotechnol. Prog., 13 (3), 311–317 (1997).

10. A. Kirdar, K. Green, and A. Rathore, Biotechnol. Prog. 24 (3), 720–726 (2008).

11. V. Saucedo et al., Biotechnol. Prog. 27 (3), 885–890 (2011).

12. M. Gawlitzek et al., Biotechnol. Bioeng. 103 (3), 1164–1175 (2009).

13. R. Godoy-Silva et al., Biotechnol. Bioeng., 103 (6), 1103–1117 (2009).

14. B. Vickroy, K. Lorenz, and W. Kelly, Biotechnol. Prog., 23 (1), 194–199 (2007).

15. Y. Maa and C. Hsu, Biotechnol. Bioeng., 51, 458–465 (1996).

16. C. Thomas, "Problems of Shear in Biotechnology," in Chemical Engineering Problems in Biotechnology, M. Winkler Ed, (Elsevier Science, 1990), pp. 25–93.

17. K. Brorson et al., Biotechnol. Bioeng. 82 (3), 321–329 (2003).

18. G. Miesegaes, S. Lute and K. Brorson, Biotechnol. Bioeng. 106 (2), 238–246 (2010).

19. G. Bolton, J. Basha. and D. LaCasse, Biotechnol. Prog. 26 (6), 1671–1677 (2010).

20. T. Hongo-Hirasaki, M. Komuro, and S. Ide, Biotechnol. Prog. 26 (4), 1080–1087 (2010).

21. G. Kern and Krishnan, BioPharm Int. 19 (10), 32–41 (2006).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

EMA Warns of Falsified Herceptin Vials
April 16, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
April 11, 2014
Author Guidelines
Source: BioPharm International,
Click here