Biosimilars and patent expiry are forcing the biopharma industry to find new ways to maintain competitiveness by ensuring affordability, quality, and delivery performance. Despite great improvements in upstream processing efficiency, higher titers create downstream processing bottlenecks and facility fit issues: Equipment reaches its physical and capacity limits thereby increasing processing time, material consumption and overall cost. Continuous processes have been proposed as a solution to many of these issues as they offer higher productivity while reducing cycle times, buffer/resin usage and required footprint. Process modeling can be used to develop and support the adoption of continuous and integrated downstream technologies by predicting and comparing process performance. More specifically, economic modeling is powerful for initial screening and detailed evaluation of process economics, resulting in process outcomes, footprint and an estimation of continuous processes’ benefits. A cost of good analysis software is used to model and compare the cost of three corresponding batch and continuous processes for the Continuous Processing Consortium which is developing and operating an automated multi-product platform for mAb downstream processing. This presentation provides (a) the approach and tools to batch and continuous process modeling, (b) models, CoGs results and comparison of 3 different batch and corresponding continuous mAb downstream processes - including cost breakdown, Gantt chart, and sensitivity analysis, and (c) strengths and weaknesses of models 

Process economic modeling of continuous, integrated biologics manufacturing

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

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