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PDA J Pharm Sci Technol. 2016 11/12;70(6):596-599. Epub 2016 Jun 20.

Risk Management in Biologics Technology Transfer.


Technology transfer of biological products is a complex process that is important for product commercialization. To achieve a successful technology transfer, the risks that arise from changes throughout the project must be managed. Iterative risk analysis and mitigation tools can be used to both evaluate and reduce risk. The technology transfer stage gate model is used as an example tool to help manage risks derived from both designed process change and unplanned changes that arise due to unforeseen circumstances. The strategy of risk assessment for a change can be tailored to the type of change. In addition, a cross-functional team and centralized documentation helps maximize risk management efficiency to achieve a successful technology transfer.


Biopharmaceutical processes; Risk management; Technology transfer

[Indexed for MEDLINE]

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