Assessing the Sustainability of Fed-Batch and Continuous Process Formats for Monoclonal Antibody Manufacturing via Bioprocess Modeling.

Achieving sustainable biomanufacturing requires understanding how process format and facility design influence environmental performance. Using process-modeling software, this study compared three monoclonal antibody (mAb) drug-substance manufacturing scenarios: single-use fed-batch (SU FB), stainless-steel fed-batch (SS FB), and single-use continuous (SU Cont). Each scenario utilized a single bioreactor facility at an equivalent annual output to assess water and materials intensity as well as facility energy demand and greenhouse gas (CO₂e) emissions. Differences in overall water intensity were primarily driven by facility type, with stainless-steel systems requiring additional cleaning water, while non-cleaning process water usage remained similar across scenarios. Variations in raw materials and consumables intensity were linked to differences in single-use versus stainless-steel manufacturing as well as process format. Energy modeling showed that facility operations (e.g., HVAC, lighting) accounted for roughly 85% of total energy use, at the scale evaluated, i.e. 500L to 2,000L, varying with facility footprint; thus, maximizing product output relative to facility size reduced both energy and carbon intensity. Sensitivity analyses on facility optimization-such as lower cleanroom classifications, increased equipment density, more efficient utilities, and even site location due to climate-indicated potential reductions in total energy use and emissions of up to approximately 35%. Overall, the results underscore the critical role of integrated process and facility design in advancing more carbon-efficient, sustainable biomanufacturing.