Reducing biopharmaceutical manufacturing costs through continuous processing in a flexible J.POD® facility

• Published in: Drug discovery today Vol. 28; no. 7; p. 103619
• Main Authors: Garcia, Fernando A., Gefroh, Eva
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.07.2023
• Subjects: Biological Products; continuous bioprocessing; economic modeling; facility design; flexible manufacturing; Humans; economic modeling; facility design; continuous bioprocessing; flexible manufacturing
• ISSN: 1359-6446; 1878-5832
• DOI: 10.1016/j.drudis.2023.103619

•Process models were developed to compare traditional stainless-steel and flexible facilities.•J.POD®, 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 manufacture 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.