Until recently the major bottleneck of monoclonal antibody manufacturing was considered to be cell culture capacity. In response to this perceived bottleneck, enormous capital investments were made throughout the biotech industry to build more cell culture capacity. At the same time, major efforts to increase cell culture product titers were undertaken. Recent reported cell culture titers of 10 g/L and higher highlight the progress made in this area. However, existing facilities were designed and built assuming much lower culture titers; this necessitated large reactor volumes and downstream capabilities sufficient to handle mass output from these low titer processes. Consequently, when a process with high cell culture titer is transferred to an existing facility, there is a discrepancy between upstream and downstream capacity in this facility. In this study, we will discuss the implications of this imbalance on facility limitations. We demonstrate that careful consideration of facility and process capabilities combined with appropriate modeling will be critical to take full advantage of these high titer improvements. Otherwise, the impact of the recent major advances in cell culture technology offer only minor improvements for process economics of monoclonal antibody processing in existing facilities.

Assessment of downstream processing facility bottlenecks due to cell culture titer improvements

243rd National Meeting (2012)

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