ABSTRACT
In today's cost-conscious environment, extending the lifetime of chromatography media can enhance the profitability of a biopharmaceutical. One should, however, keep in mind that the cost of the media is often insignificant compared to the value of the feedstream, which may have been derived from an expensive cell culture or other valuable source. How much work should a firm be willing to do to extend media lifetime? How much risk can be tolerated for a batch by pushing the limit? Various approaches have been taken-from a simple, single use and no lifetime validation up to extensive studies that allow for more than a thousand cycles. Each firm should make its own decision based on data from previous experiences, if any, resources (both human and financial), quantity of feedstream to be processed, and cost of media.
