Bioprocess Eco-design Metrics: Predicting Manufacturing Carbon Footprint During Development

This study addresses the urgent need to mitigate the climate crisis through actionable strategies in the biopharmaceuticals sector. Given the significant environmental impact associated with biologics manufacturing, particularly concerning carbon emissions, this paper explores the effectiveness of bioprocess eco-design metrics, especially process mass intensity (PMI), in predicting and reducing the carbon footprint during early process development. We utilized the BioSolve Process software application, a widely used tool for techno-economic assessment, and existing industry benchmarks to critically assess PMI's capacity to inform eco-friendly design choices in manufacturing monoclonal antibody bulk drug substance (BDS). This assessment includes a discussion of PMI's limitations, such as its lack of consideration for energy usage – a significant oversight given the energy-intensive nature of cleanroom operations. Considering these insights, the paper proposes alternative metrics, aligning with a streamlined cradle-to-gate Life Cycle Assessment (LCA) methodology, to better capture the environmental impacts of biologics production. The aim is to provide a more comprehensive framework for the biopharmaceutical industry to achieve significant reductions in carbon emissions, aligning with global sustainability goals and corporate expectations for net-zero transitions.