Perfusion processes have gained increased interest during the past few years. Major advantages with perfusion include achieving high cell concentration and viability such that high total productivity is achieved in a relatively small bioreactor volume. Possible applications for a perfusion process include production of an unstable protein, preparation of high cell density inoculum and high cell density cell banks, as well as the production of larger amounts of protein without need for a fed-batch platform.In this study, we show how a disposable perfusion process configuration, containing of a WAVE bioreactor� system, hollow fiber cartridges and tubing assemblies can be easily configured.  In the described perfused WAVE Bioreactor system, very high cell densities (e.g. 100 x 106 cells/mL and above) were stably maintained. The culture was kept in a growing phase and at high viability by continuous cell bleeds.  A maximal cell density of  214 x 106 cells/mL was achieved for what we believe is the first time in a wave-agitated bioreactor. The data presented show that perfusion can be applied for the upstream production of a recombinant monoclonal antibody. Productivity and product quality in perfusion mode is compared to production in fed-batch mode. Productivity in a 12 day process was about six times higher using the perfusion process. Related studies indicate that high cell density perfusion cultures can be used preparation of high density cell bank vials, as well as for inoculation of larger bioreactors and achieve a split ratio of up to 1:100. Cryopreservation of samples from cultures at 100 x 106 cells/mL showed good cell resuscitation and normal production while allowing significant time cuts in cell banking and cell expansion.

Cultivation process intensification utilizing a WAVE Bioreactor<sup>?TM</sup> for perfusion cell cultures

245th National Meeting (2013)

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Cultivation process intensification utilizing a WAVE Bioreactor?TM for perfusion cell cultures

Cultivation process intensification utilizing a WAVE Bioreactor^?TM for perfusion cell cultures