| Literature DB >> 31354057 |
Nada A Helal1, Ola Elnoweam1, Heba Abdullah Eassa2,3, Ahmed M Amer4, Mohamed Ashraf Eltokhy5, Mohamed A Helal6, Heba A Fayyaz1, Mohamed Ismail Nounou3.
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.Entities:
Keywords: batch; continuous manufacturing; downstream; granulation; inline; monitoring; quality-by-design; residence time; semicontinuous manufacturing; steady state
Mesh:
Year: 2019 PMID: 31354057 DOI: 10.4155/ppa-2019-0011
Source DB: PubMed Journal: Pharm Pat Anal ISSN: 2046-8954