Next Gen High Level Design of Facility Layout

Develop a Generation 2 solution in the form of a stand-alone facility layout, equipment list, project delivery methodology, high level cost estimate and implementation schedule.

Industry Need

The biopharmaceutical industry faces critical challenges with traditional manufacturing facilities that are inflexible, slow to adapt, and costly to build and operate. These limitations result in delayed medicine availability, high capital investment, and sustainability concerns.

Approach

The project team plans to develop conceptual designs for modular, flexible biomanufacturing facilities that enable rapid tech transfer and reconfiguration, guided by economic and uncertainty modeling and collaborative stakeholder input. As part of this effort, the team will also create three accelerated construction schedule options to allow next-generation facilities to be built and qualified significantly faster than traditional approaches.

Impacts

A detailed business case with capital cost estimates for a next-generation flexible facility will accelerate the adoption of continuous manufacturing by demonstrating significant cost savings and efficiency.

Economic uncertainty modeling enables better real-world comparison of innovative technology and facility design options.

Accelerated construction timelines, targeting 33 months from permitted, pad-ready site to completion of process performance qualification (PPQ) offer a significant advantage in bringing advanced therapies to patients sooner.

Value Statement/Outcomes

By implementing this project's next-generation flexible biomanufacturing facility designs, an organization realizes substantial cost savings and operational benefits. The proposed modular design build is roughly 1/10 the cost of a traditional facility. Converting an existing plant to continuous processing costs $7.4 million compared to $200 million for new construction. Faster build timelines reduce lost sales risk from an estimated $150 million to less than half, while continuous processes lower labor and resource costs. These efficiencies accelerate revenue, defer capital spend, and strengthen margins—providing a strong ROI and competitive advantage.

Outputs/Deliverables

1st Gen Facility Design (Complete)

2nd Gen Facility Design (Complete)

Economic model with uncertainty (expected Q2 2026)

Accelerated facility construction schedules (expected Q3 2026)

Presentations

Erickson, J., Presenter, Factory of the Future ICB Conference, ECI Integrated Continuous Manufacturing, Leesburg, VA, October 23, 2024

Erickson, J., Szuszkiewicz, R., Presenters, Bioprocess International West, Bioprocessing Facility Conceptual Design and Economics, San Diego, CA, March 13, 2024

Erickson, J., Workshop Chair, Factory of the Future and Enabling Technologies Workshop, NIIMBL National Meeting, Washington, DC, June 25, 2024

Szuszkiewicz, R., Presenter, NIIMBL Next Generation Manufacturing Facility, NIIMBL National Meeting, Washington, D.C., June 25, 2025.