Advances in Large-Scale Biopharmaceutical Manufacturing and Scale-up Production, just published by the American Society for Microbiology and BioPlan Associates, details the importance of cost reductions in biopharmaceutical manufacturing in reducing healthcare costs of a host of products.
US healthcare spending now accounts for 15 per cent of Gross Domestic Product - one of the highest levels in the world. And according to ex-Food and Drug Administration Commissioner Mark McClelland, manufacturing can constitute half of a pharmaceutical company's expenses, so it is a prime target for cost reduction measures.
Commenting on the new report, Acambis chief scientific officer Tom Monath, said: "Scale-up and improvements in efficiency are the obvious keys to reduction in costs and to the wider availability of life-saving products." However, he cautioned that the investments required may also compete with resources available for discovery research and new product development.
"That said, it is clear that bioengineering advances and scale-up are the keys to the reduction of manufacturing costs," added Monath.
The study identifies the challenges involved in the search for process improvements and looks at how change may be constrained by practical and regulatory concerns.
It also 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.