ABSTRACT
This chapter discusses the philosophy of developing such a process and examines several practical examples. The practical application of recombinant DNA (rDNA) technology has resulted in the availability of more than a dozen therapeutically important protein products since the early 1980s. A purification process based on chromatography is capable of reproducibly generating a high purity product in good yield and at a scale sufficient to meet market demands. The selection of the mobile phase provides the development scientist with the greatest opportunity for optimizing the selectivity of a given mode of chromatography. Equally as critical as product purity is product consistency. The development and implementation of an efficient chromatographic purification process for an rDNA product poses a variety of challenges and opportunities. While there are a wide range of variables that determine the overall effectiveness of the process, it is the sheer number and combination of these variables that makes a chromatography-based purification process highly selective.
