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Techno-economic analysis of dynamic, end-to-end optimal pharmaceutical campaign manufacturing using PharmaPy.

ABSTRACT: Increased interest in the pharmaceutical industry to transition from batch to continuouos manufacturing motivates the use of digital frameworks that allow systematic comparison of candidate process configurations. This paper evaluates the technical and economic feasibility of different end-to-end optimal process configurations, viz. batch, hybrid and continuous, for small-scale manufacturing of an active pharmaceutical ingredient. Production campaigns were analyzed for those configurations containing continuous equipment, where significant start-up effects are expected given the relatively short campaign times considered. Hybrid operating mode was found to be the most attractive process configuration at intermediate and large annual production targets, which stems from combining continuous reactors and semi-batch vaporization equipment. Continuous operation was found to be more costly, due to long stabilization times of continuous crystallization, and thermodynamic limitations of flash vaporization. Our work reveals the benefits of systematic digital evaluation of process configurations that operate under feasible conditions and compliant product quality attributes.

SUBMITTER: Casas-Orozco D

PROVIDER: S-EPMC10765457 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Techno-economic analysis of dynamic, end-to-end optimal pharmaceutical campaign manufacturing using PharmaPy.

Casas-Orozco Daniel D Laky Daniel D Wang Vivian V Abdi Mesfin M Feng X X Wood E E Reklaitis Gintaras V GV Nagy Zoltan K ZK

AIChE journal. American Institute of Chemical Engineers 20230416 9

Increased interest in the pharmaceutical industry to transition from batch to continuouos manufacturing motivates the use of digital frameworks that allow systematic comparison of candidate process configurations. This paper evaluates the technical and economic feasibility of different end-to-end optimal process configurations, <i>viz</i>. batch, hybrid and continuous, for small-scale manufacturing of an active pharmaceutical ingredient. Production <i>campaigns</i> were analyzed for those config ...[more]

PMID: 38179085

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Project description:BackgroundAlcohol-to-jet (ATJ) is one of the technical feasible biofuel technologies. It produces jet fuel from sugary, starchy, and lignocellulosic biomass, such as sugarcane, corn grain, and switchgrass, via fermentation of sugars to ethanol or other alcohols. This study assesses the ATJ biofuel production pathway for these three biomass feedstocks, and advances existing techno-economic analyses of biofuels in three ways. First, we incorporate technical uncertainty for all by-products and co-products though statistical linkages between conversion efficiencies and input and output levels. Second, future price uncertainty is based on case-by-case time-series estimation, and a local sensitivity analysis is conducted with respect to each uncertain variable. Third, breakeven price distributions are developed to communicate the inherent uncertainty in breakeven price. This research also considers uncertainties in utility input requirements, fuel and by-product outputs, as well as price uncertainties for all major inputs, products, and co-products. All analyses are done from the perspective of a private firm.ResultsThe stochastic dominance results of net present values (NPV) and breakeven price distributions show that sugarcane is the lowest cost feedstock over the entire range of uncertainty with the least risks, followed by corn grain and switchgrass, with the mean breakeven jet fuel prices being $0.96/L ($3.65/gal), $1.01/L ($3.84/gal), and $1.38/L ($5.21/gal), respectively. The variation of revenues from by-products in corn grain pathway can significantly impact its profitability. Sensitivity analyses show that technical uncertainty significantly impacts breakeven price and NPV distributions.ConclusionsTechnical uncertainty is critical in determining the economic performance of the ATJ fuel pathway. Technical uncertainty needs to be considered in future economic analyses. The variation of revenues from by-products plays a significant role in profitability. With the distribution of breakeven prices, potential investors can apply whatever risk preferences they like to determine an appropriate bid or breakeven price that matches their risk profile.

Dataset Information

Techno-economic analysis of dynamic, end-to-end optimal pharmaceutical campaign manufacturing using PharmaPy.

Publications

Techno-economic analysis of dynamic, end-to-end optimal pharmaceutical campaign manufacturing using PharmaPy.

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