The US Food and Drug Administration's 'quality by design' approach is likely to transform the manufacture of biologics.
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Acknowledgements
This article summarizes the presentations and discussions that occurred at the PDA workshop on QbD for Biopharmaceuticals held in Bethesda, MD, USA, May 21–22, 2007, and at the plenary session, “How do you sell Quality by Design (QbD)?” of the PDA/FDA Joint Regulatory Conference held in Washington, DC, USA, September 24–28, 2007. Box 2 'QbD implementation within FDA' is based on H.W.'s keynote talk on Quality by Design at a session chaired by Rick Friedman (FDA). The sections 'QbD implementation' and 'Case studies from biologics manufacture' are based on A.S.R.'s talk on Quality by Design: Business Case Studies. The authors would like to thank other participants of the QbD-related sessions and discussions at the meeting: John Towns (Eli Lilly, Indianapolis, IN, USA), Liam Feely (Abbott, Deerfield, IL, USA), Roman Drews (FDA) and Moheb Nasr (FDA).
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Rathore, A., Winkle, H. Quality by design for biopharmaceuticals. Nat Biotechnol 27, 26–34 (2009). https://doi.org/10.1038/nbt0109-26
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DOI: https://doi.org/10.1038/nbt0109-26
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