A survey of issues in biomanufacturing research

Biotechnology has become one of the primary development areas of the 21st century. For a medical device or pharmaceutical manufacturer to remain on the competitive edge, not only is it necessary to satisfy the stringent product demands of the biotechnology markets, but those companies must also develop processes that can accelerate the time frame from research and development to manufacturing and actual marketing of the medical products. Biomanufacturing is defined as the design, development, implementation and management of systems for the production of products that are integrated into or interact with human systems. This paper identifies important research issues in this relatively new manufacturing field that is anticipated to be an important area for industrial engineering, because it involves products that are expensive, complex, contain rapidly changing technology and are difficult to manufacture on a large scale.