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Integrated continuous manufacturing in pharmaceutical industry: current eolutionary steps toward revolutionary future

By Nada A Helal; Ola Elnoweam, Heba Abdullah Eassa, Ahmed M Amer, Mohamed Ashraf Eltokhy, Mohamed A Helal, Heba A Fayyaz; Mohamed Ismail Nonou

Published on CMKC

Abstract

Continuous manufacturing (CM) has the potential to provide pharmaceutical products with better quality, improved yield and with reduced cost and time. Moreover, ease of scale-up, small manufacturing footprint and on-line/in-line monitoring and control of the process are other merits for CM. Regulating authorities are supporting the adoption of CM by pharmaceutical manufacturers through issuing proper guidelines. However, implementation of this technology in pharmaceutical industry is encountered by a number of challenges regarding the process development and quality assurance. This article provides a background on the implementation of CM in pharmaceutical industry, literature survey of the most recent state-of-the-art technologies and critically discussing the encountered challenges and its future prospective in pharmaceutical industry.

Journal

Pharmaceutical Patent Analyst. Volume 8, 4, 2019, 139-161

DOI

10.4155/ppa-2019-0011

Type of publication

Peer-reviewed journal

Affiliations

  • University of Saint Joseph
  • Alexandria University
  • Alexandria University, Al Azhar University, Medizen Pharmaceutical Industries Company, Misr International University, National Marine Dredging Company

Article Classification

Review article

Classification Areas

  • Regulatory
  • PAT
  • Process Monitoring; Process Control

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