The Future of Pharmaceutical Manufacturing

Prabir Basu (), Thomas Friedli () and Daniel Bellm ()
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Prabir Basu: Pharma Manufacturing and cGMP Consultant
Thomas Friedli: University of St.Gallen
Daniel Bellm: University of St.Gallen

Chapter Chapter 29 in Leading Pharmaceutical Operational Excellence, 2013, pp 445-464 from Springer

Abstract: Abstract The pharmaceutical industry is definitely a high-tech industry, for its role in discovery of new medicines for the treatment of unmet medical needs. Pharmaceutical manufacturing is complex and sophisticated due to various reasons, but in its current state probably cannot be categorized as really high-tech, too. In fact, pharmaceutical manufacturing was considered as relatively low-tech even by the pharmaceutical companies themselves as recently as in 2002. When ex-FDA commissioner Mark McClellan sought a benchmark for future pharmaceutical manufacturing performance, he looked outside the industry, and challenged Pharma, “You need to improve…Other high-tech industries have achieved enormous productivity gains in manufacturing in the last 25 years. We should expect nothing less from the Pharmaceutical industry.”

Keywords: Model Predictive Control; Active Pharmaceutical Ingredient; Process Control System; Pharmaceutical Manufacturing; Drug Shortage (search for similar items in EconPapers)
Date: 2013
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-642-35161-7_29

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DOI: 10.1007/978-3-642-35161-7_29

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