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Improving Agility Through Scalability
Pharmaceutical Technology Europe ; 32(10):38-41, 2020.
Article in English | ProQuest Central | ID: covidwho-20242750
ABSTRACT
Miniaturized, modular, and continuous manufacturing processes will help speed scale-up, address supply chain complexity, and prevent shortages of important medications, Janet Woodcock, director of the United States Food and Drug Administration's (FDA's) Centre for Drug Evaluation and Research (CDER), noted during a meeting of the US National Academy of Sciences (NAS) in late February 2020. Describing the research at the NAS meeting (2), Rao said his team has conducted a demonstration project involving Neupogen (filgrastim) and is working with GE on development of remote bioreactor sensors to monitor analytes, oxygen, and carbon dioxide in smallscale systems in real time (2). [...]since research results were first published, he notes, robotics have been improved, and now include integrated online measurement systems using infrared (IR), FourierTransform IR, and high-pressure liquid chromatography and mass spectrometry so that key parameters can be measured in real-time, permitting online process monitoring as well as process optimization. Use of Raman and nuclear magnetic resonance (NMR) spectroscopy, refractive index, excipient identification, metabolite monitoring, and cell counts has now become routine, in both process development and manufacturing, says Christy.
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Collection: Databases of international organizations Database: ProQuest Central Type of study: Experimental Studies Language: English Journal: Pharmaceutical Technology Europe Year: 2020 Document Type: Article

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Collection: Databases of international organizations Database: ProQuest Central Type of study: Experimental Studies Language: English Journal: Pharmaceutical Technology Europe Year: 2020 Document Type: Article