Abstract Continuous manufacturing platforms and membrane chromatography are process technologies with the potential to reduce production costs and minimize process variability in monoclonal antibody production. This study presents a simulation and optimization framework to perform techno‐economic analyses of these strategies. Multi‐objective optimization was used to compare batch and continuous multicolumn operating modes and membrane and resin process alternatives, revealing performance differences in productivity and cost of goods attributed to variations in dynamic binding capacity, media geometry, and process residence time. From the set of optimal process configurations, we selected one membrane and one resin platform alternative yielding the highest net present values to undergo sensitivity analyses involving variations in batch cadence and product selling price. For the scenarios considered in this work, membrane continuous platforms showed benefits in the cost of goods and process mass intensity. Their shorter residence time compared to resins positions them as a viable alternative for single‐use capture chromatography. Moreover, this low residence time makes membrane platforms more flexible to changes in throughput, an essential feature for integrating capture into fully continuous processes.
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Technoeconomic and Sustainability Analysis of Batch and Continuous Crystallization for Pharmaceutical Manufacturing
Continuous manufacturing in pharmaceutical industries has shown great promise to achieve process intensification. To better understand and justify such changes to the current status quo, a technoeconomic analysis of a continuous production must be conducted to serve as a predictive decision-making tool for manufacturers. This paper uses PharmaPy, a custom-made Python-based library developed for pharmaceutical flowsheet analysis, to simulate an annual production cycle for a given active pharmaceutical ingredient (API) of varying production volumes for a batch crystallization system and a continuous mixed suspension, mixed product removal (MSMPR) crystallizer. After each system is optimized, the generalized cost drivers, categorized as capital expenses (CAPEX) or operational expenses (OPEX), are compared. Then, a technoeconomic and sustainability cost analysis is done with the process mass intensity (PMI) as a green metric. The results indicate that while the batch system does have an overall lower cost and better PMI metric at smaller manufacturing scales in comparison with the continuous system, the latter system showed more potential for scaling-up for larger production volumes.
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- Award ID(s):
- 2229250
- PAR ID:
- 10549722
- Publisher / Repository:
- Syst. Control Trans.
- Date Published:
- Volume:
- 3
- Page Range / eLocation ID:
- 359 to 366
- Format(s):
- Medium: X
- Location:
- Breckenridge, Colorado, USA
- Sponsoring Org:
- National Science Foundation
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