Highlights
- Continuous Bioprocessing, Flexible Manufacturing, Facility Design, Economic Modeling.
- Process models were developed to compare traditional stainless-steel and flexible facilities.
- J.PODTM , a flexible facility employing single-use, portable cleanroom technologies is introduced.
- Varying cost structures and utilization rates are compared across different facility types.
- A dynamic simulation approach is used to model a low-cost biologic drug with uncertain demand.
In this work, process models were developed to capture the impact of biomanufacturing costs on a commercial scale and emphasize the way in which facility design and operation must balance meeting product demand while minimizing production costs. Using a scenario-based modeling approach, several facility design strategies were evaluated, including a traditional large stainless-steel facility and a small footprint, portable-on-demand (POD)-based facility. Bioprocessing platforms were compared by estimating their total production costs across different facility types and specifically illustrating how continuous bioprocessing has gained in popularity as a novel and cost-effective approach to manufacturing high-quality biopharmaceuticals. The analysis showed how fluctuations in market demand have a dramatic effect on manufacturing costs and plant utilization, with far-reaching implications on the total cost to patients.