"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.
The American Society for Microbiology is the oldest and largest single life science membership organization in the world. The ASM's mission is to promote research in the microbiological sciences and to assist communication between scientists, policy makers, and the public to improve health and foster economic well-being. Advances in Large-Scale Biopharmaceutical Manufacturing and Scale-up Production was edited by Eric Langer of BioPlan Associates, Inc. which has provided market assessment services to biopharmaceutical and healthcare companies since1989 (www.bioplanassociates.com).