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

Author:

Helal Nada A1,Elnoweam Ola1,Eassa Heba Abdullah23,Amer Ahmed M4,Eltokhy Mohamed Ashraf5,Helal Mohamed A6,Fayyaz Heba A1,Nounou Mohamed Ismail3

Affiliation:

1. Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria 21521, Egypt

2. Department of Pharmaceutics & Industrial Pharmacy, College of Pharmacy for Girls, Al Azhar University, Cairo 11651, Egypt

3. Department of Pharmaceutical Sciences (DPS), School of Pharmacy & Physician Assistant Studies (SOPPAS), University of Saint Joseph (USJ), Hartford, CT 06103, USA

4. Research & Development Department, Medizen Pharmaceutical Industries company, Alexandria 21521, Egypt

5. Department of Microbiology, Faculty of Pharmacy, Misr International University, Cairo 11757, Egypt

6. Construction Planning Department, National Marine Dredging Company (NMDC), Abu Dhabi 11372, United Arab Emirates

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.

Publisher

Future Science Ltd

Subject

General Medicine

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