Abstract
Lyophilization is a unit operation that is routinely used to stabilize an otherwise unstable molecule to achieve pharmaceutically acceptable shelf life. The lyophilization process is based on fundamental principles of heat and mass transfer, and the overall understanding of the impact of process parameters on product quality attributes has increased significantly over the past few decades. Quality by design (QbD) aims at building quality within the process rather than monitoring offline at the end of the process. This chapter describes how QbD elements—risk assessment, process characterization, PAT (Process Analytical Tool), and Design Space—can be applied to design, develop, and scale-up of the lyophilization process.
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Notes
- 1.
Overall score is determined as sum of product of quality attribute and process parameter score.
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Patel, S., Jameel, F., Sane, S., Kamat, M. (2015). Lyophilization Process Design and Development Using QbD Principles. 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_14
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