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

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.