Quality by Design applications in biosimilar pharmaceutical products |
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Authors: | Ron S Kenett Dan A Kenett |
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Institution: | (1) KPA Ltd., Raanana, Israel;(2) University of Torino, Torino, Italy;(3) Teva Pharmaceutical Ind. Ltd., Rehovot, Israel |
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Abstract: | A process is well understood when all critical sources of variability are identified and explained, variability is managed
by the process design and monitoring, and product quality attributes are accurately and reliably predicted over the design
space. Quality by Design (QbD) is a systematic approach to product development and process control that begins with predefined
objectives, emphasizes product and process understanding, and sets up process control based on sound science and quality risk
management. The Food and Drug Administration (FDA) and the International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH) have recently started promoting QbD in an attempt to curb rising development
costs and regulatory barriers to innovation and creativity. QbD is partially based on the application of multivariate statistical
methods and a statistical Design of Experiments strategy to the development of both analytical methods and pharmaceutical
formulations. In this paper, we review the basics of QbD and their impact on the innovative, generic, and biosimilar pharmaceutical
industry. In particular, we consider the challenge of mapping the control space in biotechnological processes and how advances
in statistical methods can contribute to QbD. |
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Keywords: | Quality by Design Design of Experiments Simulation experiments Multivariate methods Analytical methods Specification limits Biosimilars |
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