ABSTRACT
A manufacturer’s decision to scale-up (or scale-down) a process is ultimately rooted in the economics of the production process, i.e., in the cost of material, personnel, and equipment associated with the process and its control. While process scale-up often reduces the unit cost of production and is therefore economically advantageous per se, there are additional economic advantages conferred on themanufacturer by scaling-up a process. Thus, process scale-up may allow for faster entry of amanufacturer into themarketplace or improved product distribution or response to market demands and correspondingly greater market-share retention.a Given the potential advantages of process scale-up in the pharmaceutical industry, one would expect the scale-up task to be the focus of major efforts on the part of pharmaceutical manufacturers. However, the paucity of published studies or data on scale-up-particularly for non-parenteral liquids and semisolids-suggests otherwise. On the other hand, one could argue that the paucity of published studies or data is nothing
more than a reflection of the need to maintain a competitive advantage through secrecy.
