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 the next-generation flexible biomanufacturing facility designs, an organization could realize substantial cost savings and operational benefits. The capital cost per kilogram of capacity is half the cost of a traditional stainless steel bioreactor facility (6 x 15,000 L). The design is flexible enough to allow the facility to switch easily between traditional batch and continuous operation.

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

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