ABSTRACT

Chromatography and Œltration media often dominate the cost of raw materials for the whole process [1]. As such, from a process economics point of view, it is important to be able to recycle the media through an appropriate number of cycles before replacing it with new media. The optimal number of cycles for a media that should be targeted varies from product to product and company to company and depends on several considerations, which include media cost, the approach toward and timing of the various process validation activities, cost of a batch of product, number of batches to be run every year, and so on. The cost of the media varies in a wide spectrum, e.g., $6500/L for rProtein A Sepharose Fast Flow® (Amersham Biosciences) to $400/L for High S Macroprep® (BioRad). Similar variation is also seen in the various kinds of Œltration media that are available on the market today.