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Single-use technologies and sustainability by design in biopharma production
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DOI：10.1007/s00253-026-13930-x.png)
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Abstract
En 中文
Sustainability has become a central challenge for the biopharmaceutical industry, which is characterized by resource-intensive manufacturing processes, complex supply chains, and increasing regulatory expectations for environmental transparency. This review examines the role of single-use technologies (SUTs) and sustainability by design (SbD) approaches in improving the environmental performance of modern biomanufacturing systems. While SUTs offer operational advantages such as increased flexibility, faster facility turnaround, and reduced water and energy consumption compared with stainless steel systems, their widespread adoption also raises concerns regarding plastic waste generation and end-of-life management. Survey results from industry stakeholders further indicate increasing awareness of sustainability challenges, but also reveal gaps in knowledge, governance structures, and practical implementation across the value chain. The paper aims to summarize recent developments in environmental assessment, process engineering, and digital bioprocessing to evaluate pathways toward more sustainable production and, at the same time, to identify knowledge gaps that remain. Emphasis is placed on the integration of life cycle assessment (LCA) and quantitative sustainability metrics into early process development, enabling more informed technology selection and design decisions now and in the future. In addition, emerging technological strategies are discussed, including process intensification, continuous and hybrid manufacturing configurations, and advanced process analytical technologies (PATs) that support real-time monitoring and resource-efficient operation. Overall, the findings highlight that an integrated systems perspective is required that combines technological innovation, standardized environmental metrics, and collaborative industry frameworks. Embedding SbD principles early in product and process development can significantly reduce environmental impacts while maintaining regulatory compliance and economic feasibility.
Keywords:
Biopharmaceutical manufacturing
Life cycle assessment
Bioprocess intensification
Process analytical technology
Circularity
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