Manufacturing Economics of Plant-Made Biologics: Case Studies in Therapeutic and Industrial Enzymes

TLDR

Plant‑made biologics offer eukaryotic protein processing, safety from adventitious agents, scalable and rapid production, and are often claimed to be cheaper than microbial or animal cell systems, yet robust cost data are scarce. The study presents two techno‑economic case studies of plant‑produced enzymes: human butyrylcholinesterase for medical countermeasures and cellulases for biomass conversion to ethanol. Using SuperPro Designer, the authors modeled production economics for Nicotiana‑based expression systems, evaluating unit operations and calculating bulk, per‑dose, and per‑unit costs. Analyses show that plant systems can achieve substantial cost advantages, but these benefits are molecule‑specific and depend on the relative efficiencies of alternative production sources.

Abstract

Production of recombinant biologics in plants has received considerable attention as an alternative platform to traditional microbial and animal cell culture. Industrially relevant features of plant systems include proper eukaryotic protein processing, inherent safety due to lack of adventitious agents, more facile scalability, faster production (transient systems), and potentially lower costs. Lower manufacturing cost has been widely claimed as an intuitive feature of the platform by the plant-made biologics community, even though cost information resides within a few private companies and studies accurately documenting such an advantage have been lacking. We present two technoeconomic case studies representing plant-made enzymes for diverse applications: human butyrylcholinesterase produced indoors for use as a medical countermeasure and cellulases produced in the field for the conversion of cellulosic biomass into ethanol as a fuel extender. Production economics were modeled based on results reported with the latest-generation expression technologies on Nicotiana host plants. We evaluated process unit operations and calculated bulk active and per-dose or per-unit costs using SuperPro Designer modeling software. Our analyses indicate that substantial cost advantages over alternative platforms can be achieved with plant systems, but these advantages are molecule/product-specific and depend on the relative cost-efficiencies of alternative sources of the same product.