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Quality by design for biopharmaceuticals

Nature Biotechnology volume 27, pages 26–34 (2009)Cite this article

The US Food and Drug Administration's 'quality by design' approach is likely to transform the manufacture of biologics.

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Figure 1: Case study in which IEX step removes Impurity 1 to below drug substances specifications.
Figure 2
Figure 3: The dependencies among clinical (purple), product (pink) and process (green) design spaces for products X and Y.
Figure 4: The creation of process design space from process characterization studies and its relationship with the characterized and operating space.
Figure 5
Figure 6: Pareto chart showing RPN scores for the operating parameters for a chromatography step in a biotech process.
Figure 7: Results from the process characterization studies performed at small scale.

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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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Authors and Affiliations

  1. Anurag S. Rathore is in Process Development, M/S 30-2-A, One Amgen Center Drive, Thousand Oaks, California 91320, USA. asrathore@yahoo.com,

    Anurag S Rathore

  2. Helen Winkle is in the Office of Pharmaceuticals, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857-0001, USA.,

    Helen Winkle

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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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