Protein A resin is a major cost driver in the manufacture of therapeutic antibodies, particularly in early stages of development where the lifetime of the resin cannot be exploited. In this work, we present a general approach for the maximization of volumetric productivity in chromatography, using the example of Protein A capture. Optimization was achieved by balancing flow rate with dynamic capacity based on the shrinking core model approach, as well as by reducing bed height and minimizing process volumes. Materials and buffer conditions for the optimized process remain identical to the non-optimized protocol. The resulting gain in volumetric productivity translated into significant resin and overall process cost savings. Applicability of the optimized protocol has been demonstrated for several antibodies at laboratory, pilot and manufacturing scale.

Maximizing productivity of protein A capture

251st National Meeting (2016)

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