Journal of Pharmaceutical Innovation

, Volume 10, Issue 3, pp 191–199 | Cite as

Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production

  • 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
Review Article

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.

Keywords

Continuous processing Quality by design Process analytical technology Control strategy Traceability 

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Copyright information

© "Springer Science+Business Media New York (outside the USA) 2015

Authors and Affiliations

  • Sau L. Lee
    • 1
  • Thomas F. O’Connor
    • 1
  • Xiaochuan Yang
    • 1
  • Celia N. Cruz
    • 1
  • Sharmista Chatterjee
    • 1
  • Rapti D. Madurawe
    • 1
  • Christine M. V. Moore
    • 1
  • Lawrence X. Yu
    • 1
  • Janet Woodcock
    • 1
  1. 1.Office of Pharmaceutical Quality, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA

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