3 years ago

Modeling the downstream processing of monoclonal antibodies reveals cost advantages for continuous methods for a broad range of manufacturing scales

Rick Stock, Xhorxhi Gjoka, Terence Davidovits, Thomas Ransohoff, Mark Schofield, Rene Gantier, Mark Pagkaliwangan, Jonathan Hummel
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 of Pall Life Science's integrated, continuous bioprocessing platform was modeled, along with that of purification processes in stainless-steel and single-use batch formats. All three models included costs associated with downstream processing only. 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. These findings indicate that existing and imminent continuous technologies and equipment could become key enablers for more cost effective manufacturing of biopharmaceuticals.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1002/biot.201700665

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