ABSTRACT
This chapter gives an overview of the techno-economic opportunities and obstacles of relevance to the successful scale-up of biotechnical processes. It develops a project model and presents capital and manufacturing cost data for the production of human insulin using a recombinant-DNA-based Escherichia coli fermentation. The small entrepreneurial companies are rarely competent, technically and financially, to bring the new products through the scale-up and commercialization stages. Several large-scale applications of biotechnology, such as better utilization of renewable resources, depend for their profitability on political decisions. Pilot-plant studies usually add a couple of years and at least several hundred thousand dollars to the development process but are of crucial importance before several million dollars can be committed to a full-scale facility. Nature of medium, length of cycle, and process conditions determine whether batch or continuous sterilization is to be used. The economics of downstream processes have an interesting relationship with product value.
