The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing

There is a trend across the pharmaceutical sector toward process intensification and continuous manufacturing to produce small-molecule drugs or biotechnology products. For biotechnology products, advancing the manufacturing technology behind upstream and downstream processes has the potential to re...

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Veröffentlicht in:	Trends in biotechnology (Regular ed.) 2019-03, Vol.37 (3), p.253-267
Hauptverfasser:	Fisher, Adam C., Kamga, Mark-Henry, Agarabi, Cyrus, Brorson, Kurt, Lee, Sau L., Yoon, Seongkyu
Format:	Artikel
Sprache:	eng
Schlagworte:	Biological products Biological Products - isolation & purification Biological Products - metabolism Biopharmaceuticals Biotechnology Biotechnology - methods Biotechnology - trends Capital costs Chromatography continuous bioprocessing Design disposable Drug Approval - methods Drugs FDA approval Flexibility Manufacturing Perfusion Pharmaceutical industry Pharmaceuticals process analytical technology Process controls Process intensification Product quality Production costs Productivity quality by design regulatory Shortages Technology, Pharmaceutical - methods Technology, Pharmaceutical - trends Upstream
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