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

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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,
.

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