Continuous processing is a paradigm shift for the manufacture of biopharmaceuticals.  The technology provides numerous efficiency improvements with equivalent or better product quality.    Simultaneous operation of each purification step combined with improved productivity results in dramatically reduced run rates. Additionally, the purification train can be synchronized to the flow rate of a perfusion bioreactor.  Significant consumable cost savings are achieved due to higher binding capacities and increased cycling of resins.  Reduced capital funding is required with the elimination of intermediate product hold tanks, and lower flow rates enable the use of single use tubing and vessels, even at the 20,000 L bioreactor scale.<br/><br/>This presentation outlines the new technologies, engineering solutions and practical considerations of a fully integrated purification process from cell culture through final formulation, demonstrated at pilot scale.  The overall purification process design and the individual unit operation technologies are described, including novel viral inactivation and diafiltration steps.  The implementation of a closed purification process, to enable a run over extended durations, is discussed.  Lastly, automation control strategies and process analytical technologies are presented.

Continuous manufacture of biopharmaceuticals: Engineering solutions to enable improved productivity and facility capacity management

255th National Meeting (2018)

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