As the number of candidate biotherapeutic drugs increases, the need for high titer yielding, efficient production processes to supply the clinic and maximize clinical manufacturing capacity has become apparent. A fed batch process is routinely used throughout the industry because of its ability to deliver high product concentration and its operational simplicity.  Common fed-batch development approaches focus on maximizing specific productivity (qp) and/or integral of viable cells (IVC), although it is not atypical for a decrease in qp to accompany an increase in IVC.  MedImmune's cell culture platform feeds were enriched, and reformulated in order to achieve an improved balance of the nutrients and optimization of the overall feed volume.  The current study with a representative cell line focused on feed development optimization and process set-points to increase volumetric productivity and optimize process throughput.  Additionally, modulation of the viable cell density on day of inoculation was used in order to increase the daily volumetric productivity to > 600 mg/L/day, with a peak daily volumetric productivity of over 1000 mg/L/day. These approaches increased antibody productivity by increasing the qp by approximately two-fold while still maintaining high IVC. This resulted in an increase in volumetric productivity from approximately 4 g/L to 8 g/L while shortening the duration of the process by four days.

High titer and high-throughput cell culture process development

241st National Meeting (2011)

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