Abstract
The concept of Quality by Design (QbD) has been applied to the development of small-molecule pharmaceuticals and is increasingly being applied to the development of biopharmaceuticals. The successful implementation of a QbD approach requires a good understanding of its key elements. These include the quality target product profile (QTPP), critical quality attributes (CQAs), critical material attributes (CMAs), risk assessments, design space, critical process parameters (CPPs), a comprehensive control strategy, and lifecycle management. In this chapter, we have provided the basic definitions and considerations necessary to deliver these key elements for biopharmaceutical development.
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Taticek, R., Liu, J. (2015). Definitions and Scope of Key Elements of QbD. 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_3
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DOI: https://doi.org/10.1007/978-1-4939-2316-8_3
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