October 13, 2004 (Washington, DC) – Cost reductions associated with advances in large-scale biopharmaceutical manufacturing will play a role in reducing healthcare costs, according to a new industry joint publication by ASM Press, the book publishing division of the American Society for Microbiology, and BioPlan Associates. Advances in Large-Scale Biopharmaceutical Manufacturing and Scale-up Production details the importance of cost reductions in biopharmaceutical manufacturing--paramount to the segment's competitiveness and the effort to reduce healthcare costs. US healthcare spending now accounts for 15% of GDP. And according to ex-FDA Commissioner Mark McClelland, manufacturing can constitute half of a pharmaceutical company's expenses, so it is a prime target for cost reduction measures.
"Scale-up and improvements in efficiency are the obvious keys to reduction in costs and to the wider availability of life-saving products, but the investments required may also compete with resources available for discovery research and new product development," says Acambis Chief Scientific Officer Tom Monath. "However, it is clear that bioengineering advances and scale-up are the keys to the reduction of manufacturing costs."
The study identifies the challenges involved in the search for process improvements while recognizing that change may be constrained by practical and regulatory concerns. The study addresses new frontiers in bioprocessing and novel technologies, technical issues in protein expression and other areas, and offers an analysis of scale-up production factors, product purification, process design, good automation manufacturing practices, and regulatory compliance issues. It also discusses commercial market dynamics, worldwide capacity factors, demand forecasting, strategic decision-making, intellectual property, capital investment, and biopharmaceutical manufacturing training. Contributing author organizations include Amgen, BD Technologies, Burrill & Co., Eli Lilly, Ernst & Young, GE Healthcare, Merck Research Laboratories, National Institutes of Health, and many others.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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