ABSTRACT

Bioprocess engineering is a particularly resource intensive part of biological drug development, requiring long-term investment in specialized capital equipment. This chapter addresses the economic and cost factors of bioprocess engineering, with a focus on three main areas: development, facilities, and operations. The fundamental reason for economic evaluation is that a choice exists between investment alternatives. Depreciation is subtracted from revenues and shows up as an operating expense, though it does not result in an outlay of cash. The chapter considers the time value of money and allows a comparison of projects with different lifetimes. The prime cost drivers tend to be raw materials, labor, depreciation, and other fixed costs. Generally, because of the impact of fixed costs, including depreciation, on the cost of manufacturing, and as a result of the economies of scale that are realized with larger equipment, the lowest unit cost is achieved with the volume operation.