Abstract
The transfer of drug product (DP) manufacturing process to a different site is a complex process that can benefit by application of a risk-based approach. The different phases of the technology transfer process are presented with particular emphasis on the gap assessment phase where differences between the donor and receiving site are identified. Case studies are provided to illustrate how a quality risk management approach is used to assess and mitigate identified gaps or risks. Several risk-assessment tools are also described. Finally, strategies are presented to assess whether product produced from the donor and receiving site is of comparable quality.
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Lim, F., Sundaram, J., Sreedhara, A. (2015). Application of Quality by Design Principles to the Drug Product Technology Transfer Process. In: Jameel, F., Hershenson, S., Khan, M., Martin-Moe, S. (eds) Quality by Design for Biopharmaceutical Drug Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 18. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-2316-8_27
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DOI: https://doi.org/10.1007/978-1-4939-2316-8_27
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