ABSTRACT
The successful scale-up of a protein purification process to commercial production is the culmination of all research and development activities. We will discuss the elements of a successful scale-up strategy as well as process control and monitoring during production. The main emphasis will be on chromatographic separations, since they are at the heart of virtually all recombinant protein purification schemes. The scale-up strategy for a welldeveloped process can be relatively straightforward. However, consideration of commercial processing constraints during the design phase is critical to ensure that a viable, efficient, and validatable process is delivered to the production environment.
