Decision Support Method for the Choice between Batch and Continuous Technologies in Solid Drug Product Manufacturing

Matsunami, Kensaku; Miyano, Takuya; Arai, Hiroaki; Nakagawa, Hiroshi; Hirao, Masahiko; Sugiyama, Hirokazu

doi:10.1021/acs.iecr.7b05230

Cited by 45 publications

(23 citation statements)

References 44 publications

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“…This indicator was extended from the conventional NPV [36] by considering the cash flow in the drug lifecycle, in particular, the development cost C dev . For the operating cost, C op (τ), the existing economic evaluation model proposed by our group [22] was used. In case continuous technology is considered as the alternative, an optimization algorithm is run to specify the validated run time to maximize the third term in Eq.…”

Section: Economic Assessment Model Overview Of Economic Assessmentmentioning

confidence: 99%

“…In case continuous technology is considered as the alternative, an optimization algorithm is run to specify the validated run time to maximize the third term in Eq. (1) (see [22] for details).…”

Section: Economic Assessment Model Overview Of Economic Assessmentmentioning

confidence: 99%

“…The first constraint serves as the rejection criterion for an alternative. The second, third, and fourth constraints consider the mass balance of raw materials and products/ losses, time-related constraints, e.g., the validated run time for continuous technology, and pharma-specific aspects, e.g., safety stock, respectively (see [22] for the details).…”

Section: Economic Assessment Model Overview Of Economic Assessmentmentioning

confidence: 99%

“…− 1 ] represents capacity cost, i.e., the loss of profits from capacity displaced by the new product as an additional operating cost. The original model in [22] was only for comparing the batch and continuous technologies; in this work, we extended the model to assess all possible process alternatives. Solid drug product manufacturing is a linear process without recycling, and thus the mass balance is simple.…”

Section: Details Of Economic Assessmentmentioning

confidence: 99%

“…Aigner et al proposed a ranking-based economic comparison method between batch and continuous processes, which can be used in the early stages of process development [21]. For the later development stages, Matsunami et al presented a method for selecting batch and continuous processes based on the net present operating cost [22]. By conducting industrial scale experiments, Matsunami et al compared the product quality and process performance of both processes, providing insights for process-related decision-making [23].…”

Section: Introductionmentioning

confidence: 99%

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Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing

et al. 2020

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This paper presents a new method for process synthesis and economic assessment for solid drug product manufacturing, considering continuous manufacturing as a prominent process alternative. Of the three phases of drug development, phase II was targeted where the dosage form, formulation, and processing technology are determined. For a comprehensive alternative generation, a superstructure was developed that covered 9452 options for the unit level, which was combined with two options on the formulation strategy. The generated alternative was assessed by a net present value calculation model, which was adapted for dynamic cash flow consideration in the drug lifecycle. The model can incorporate uncertainty in the drug development and manufacturing in the result, and can perform global sensitivity analysis by Monte Carlo simulation. The method was demonstrated in a case study where two different scenarios regarding the price of the active pharmaceutical ingredient and the demand for the product were assumed. The results showed that when the demand and price are both low, the labor-related costs are dominant, and in the opposite case, the material-related costs become relevant. We also introduce the prototype version of the software "SoliDecision," by which the presented method was implemented for industrial application.

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Section: Economic Assessment Model Overview Of Economic Assessmentmentioning

confidence: 99%

Section: Economic Assessment Model Overview Of Economic Assessmentmentioning

confidence: 99%

Section: Economic Assessment Model Overview Of Economic Assessmentmentioning

confidence: 99%

Section: Details Of Economic Assessmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing

et al. 2020

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Enabling energy‐efficient manufacturing of pharmaceutical solid oral dosage forms via integrated techno‐economic analysis and advanced process modeling

Sampat

Kotamarthy

Bhalode

et al. 2022

J Adv Manuf & Process

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The global pharmaceutical industry is a trillion-dollar market. However, the pharmaceutical sector often lags in manufacturing innovation and automation which limits its potential to maximize energy efficiency. The integration of technoeconomic analysis (TEA) with advanced process models as part of an overarching smart manufacturing platform, can help industries create business models, which can be adapted for manufacturing to reduce energy consumption and operating costs while ensuring product quality which can further enable a more sustainable process operation. In this study, a rational design of experiment on three unitoperations (wet granulation, drying, and milling) was performed on a batch (case 1) and continuous (case 2) pharmaceutical process to obtain experimental data. Process models for predicting product quality and energy efficiency of each of the three-unit operations were developed. The experimental data were used to validate the models and good agreement was observed. The energy consumption of each unit operation was calculated using statistical models relating the power consumption and the process parameters. The developed process models and energy models were further integrated into a TEA framework, which quantified the energy and monetary cost of manufacturing for both batch and continuous manufacturing cases. With this integrated framework, energy costs savings of ~33% was obtained in the continuous manufacturing process (case 2) over the batch process (case 1). K E Y W O R D Sadvanced process models, energy efficiency, Industry 4.0, smart manufacturing, technoeconomic analysis Chaitanya Sampata and Lalith Kotamarthy contributed equally to this study.

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Design Framework and Tools for Solid Drug Product Manufacturing Processes

Matsunami

Badr

Sugiyama

2022

Optimization of Pharmaceutical Processes

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Decision Support Method for the Choice between Batch and Continuous Technologies in Solid Drug Product Manufacturing

Cited by 45 publications

References 44 publications

Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing

Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing

Enabling energy‐efficient manufacturing of pharmaceutical solid oral dosage forms via integrated techno‐economic analysis and advanced process modeling

Design Framework and Tools for Solid Drug Product Manufacturing Processes

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