The biopharmaceutical industry is evolving in response to changing market conditions, including increasing competition and growing pressures to reduce costs. Single-use technologies and continuous bioprocessing have attracted attention as potential facilitators of cost-optimized manufacturing for monoclonal antibodies. While disposable bioprocessing has been adopted at many scales of manufacturing, continuous bioprocessing has yet to reach the same level of implementation. In this study, the cost of goods for both upstream and downstream processing were modeled. The costs associated with different upstream production formats and strategies were modeled and compared. A particular focus was placed on cell retention for perfusion cell culture to identify the cost differential between acoustic wave separation, alternating tangential flow filtration, and tangential flow filtration. Three downstream manufacturing strategies were also modeled: Pall Life Science’s integrated, continuous bioprocessing platform, a stainless-steel batch process, and a single-use batch process. Evaluation of the models across a broad range of clinical and commercial scenarios revealed that the cost savings gained by switching from stainless-steel to single-use batch processing are often amplified by continuous operation. The continuous platform exhibited the lowest cost of goods across 78% of all scenarios modeled here, with the single-use batch process having the lowest costs in the rest of the cases. The relative savings demonstrated by the continuous process were greatest at the highest feed titers and volumes.

Process economics of continuous bioprocessing

255th National Meeting (2018)

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