This work presents a decision support method for the choice between batch and continuous technologies in solid drug product manufacturing based on the economic evaluation. The method consists of four steps: (I) modeling of operating costs, (II) evaluation, (III) sensitivity analysis, and (IV) interpretation, with iterations. For a given design situation, manufacturing processes are modeled and evaluated with consideration for the characteristics of the two technologies. The sensitivity of the input parameters is analyzed; after interpreting all results, the economically preferable technology is suggested. As a case study, the method was applied to a situation where a new product was in the late development stage, and one of the two technologies needs to be chosen. After executing the four steps, the comparison result of the net present cost was obtained as the decision support information.

Pharmaceuticals represent a significant contributor to the environmental impact of healthcare. Biopharmaceuticals are a rapidly growing category in that industry. They provide considerable health benefits, but the environmental impact to produce them is still largely unclear. In this paper, we examined the cost–benefit of monoclonal antibody (mAb) production in terms of operating cost and environmental impact through an extended life cycle assessment including 15 environmental categories, disability-adjusted life years, and Eco-index. Based on a detailed kinetic model, we assessed the impacts of four production scenarios at a commercial scale of batch and continuous production using single-use and multi-use equipment. We further performed a sensitivity analysis on the cost–benefit analysis results to determine elements with the highest impact on process improvement. The results showed that there is a trade-off between the operating cost and human health among the four process scenarios. Continuous modes (i.e., perfusion cultivation) have the least human health damage but with the highest operating costs, while the combination of fed-batch and multi-use equipment yields the lowest operating cost with the highest human health damage. To improve the cost–benefit of mAb cultivation, the sensitivity analysis showed the high effectiveness of potential improvements to cell’s growth characteristics such as the specific production rate.

This paper compares batch and continuous technologies in terms of product quality and process performance in pharmaceutical tablet manufacturing using ethenzamide as the active pharmaceutical ingredient. Batch and continuous processes using wet granulation were investigated by performing experiments on the scale of 5 and up to 100 kg/lot, using the same raw materials. Three technologies were tested and compared: (i) batch technology using fluidized bed granulation, (ii) batch technology using high shear granulation, (iii) continuous technology using high shear granulation. In the full-scale experiment, in all three technologies including continuous technology, the quality of the tablets fulfilled the target values regarding hardness, active pharmaceutical ingredient content, and dissolution. The granules produced by different technologies, however, presented varying attributes regarding granule size distribution, loose bulk density, or scanning electron microscope images. The process performance, more specifically the yield, was slightly better for batch technologies than for the continuous technology, mainly due to losses in the start-up operation. Notably, this study has shown that continuous technology, which is generally believed to not entail scale-up procedures, could in fact, require parameter adjustment for prolonged operation. The results provided suggestions for improvements to implement large-scale continuous technologies in the pharmaceutical industry.

This paper presents design approaches to induce behavioral shifts toward product sharing through a case study on laundry activities in Japan. Business models involving provision of temporary access to goods are garnering attention as a way to reduce environmental impacts from the current pattern of consumption. However, the success of such business models is a matter of consumer choice, and there exist hurdles for consumers to forego ownership and transfer to product sharing. To understand the forces that affect consumer behavior involving product sharing and to design effective interventions for behavioral shifts, we conducted in-depth interviews and a web survey. From the results, we specified the decision processes in a behavioral shift between home washing and laundromat use, and generated “implementation of a communal laundromat in an apartment building” as a promising way for consumers to shift toward laundromat use. Based on our calculation, the proposed approach has a potential to reduce environmental impact of a hypothetical community by 1.8% in greenhouse gas emissions and 16% in resource use relative to when only home washing is practiced. Our study provides an example of designing interventions for product sharing through reflecting actual usage patterns and consumer motivations.