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Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production

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Abstract

The Food and Drug Administration (FDA) regulates pharmaceutical drug products to ensure a continuous supply of high-quality drugs in the USA. Continuous processing has a great deal of potential to address issues of agility, flexibility, cost, and robustness in the development of pharmaceutical manufacturing processes. Over the past decade, there have been significant advancements in science and engineering to support the implementation of continuous pharmaceutical manufacturing. These investments along with the adoption of the quality-by-design (QbD) paradigm for pharmaceutical development and the advancement of process analytical technology (PAT) for designing, analyzing, and controlling manufacturing have progressed the scientific and regulatory readiness for continuous manufacturing. The FDA supports the implementation of continuous manufacturing using science- and risk-based approaches.

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Authors and Affiliations

  1. Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA

    Sau L. Lee, Thomas F. O’Connor, Xiaochuan Yang, Celia N. Cruz, Sharmista Chatterjee, Rapti D. Madurawe, Christine M. V. Moore, Lawrence X. Yu & Janet Woodcock

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  1. Sau L. Lee
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  2. Thomas F. O’Connor
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  3. Xiaochuan Yang
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  4. Celia N. Cruz
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  5. Sharmista Chatterjee
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  6. Rapti D. Madurawe
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  7. Christine M. V. Moore
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  8. Lawrence X. Yu
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  9. Janet Woodcock
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Correspondence to Lawrence X. Yu.

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Lee, S.L., O’Connor, T.F., Yang, X. et al. Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production. J Pharm Innov 10, 191–199 (2015). https://doi.org/10.1007/s12247-015-9215-8

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  • DOI: https://doi.org/10.1007/s12247-015-9215-8

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