Industry interest in biopharmaceutical integrated continuous processing is steadily on the rise, but technology gaps still exist that hinder the complete transformation to process scale GMP continuous biomanufacturing. With a steady stream of new manufacturing solutions rising to fill these gaps, applicable technologies should be thoroughly evaluated across scales to fully understand the benefits, challenges, and design implications. Multicolumn chromatography has been a recent focus point in the transition to continuous due to the importance of robust chromatographic solutions in bioprocessing as well as its potential cost benefits.<br/>Here we assess a scalable continuous chromatography solution, the Cadence BioSMB. Productivity and column configuration strategies are modeled to demonstrate optimized operating conditions based on equipment capability. The most productive scenarios are performed on the Cadence BioSMB PD and then shown to be scalable with a roughly 100-fold scale up in both column volume and load flow rate using the Cadence BioSMB Process 80. These experiments validate the modeling, which can then be used to plan and design downstream continuous purification based on actual available equipment and capabilities. The modeling is then used to identify purification scenarios where continuous processing can supply considerable advantages over batch.

Process80 BioSMB Evaluation and Scale up Assessment

2019 Spring National Meeting

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