Enabling in-house manufacturing for a therapeutics start-up
To advance the mission of defeating neurodegenerative disease, the Denali Therapeutics team charted a course to bring manufacturing in-house. CRB led the design and construction of this project under a design-build agreement, delivering the project on time and under budget.
In 2025, Denali Therapeutics Inc. officially opened its first clinical biomanufacturing facility, located in Salt Lake City, Utah. This biotech facility boasts 60,000 square feet, including 20,000 square feet of in-house GMP manufacturing space, with supporting labs, offices, and warehouse space, with roughly 17,000 square feet added for a second-floor mezzanine. In its first year of operations, the site team achieved 9 runs and counting.
Project Details
Client
Denali Therapeutics Inc.
Location
Salt Lake City, Utah
Square Footage
60,000
Design-build efficiency
CRB’s integrated, design-build team collaborated with Denali from concept through completion, aligning the facility’s technical design with scientific and operational goals. This partnership enabled efficient decision-making through parallel design and construction, resulting in a streamlined execution. Project efficiency was further enforced through multiple VR site walkthroughs and Matterport scans, enabling quick, cross-country team alignment and collaboration. To reduce risk of startup delays, detailed operational readiness planning and CQV processes were incorporated early in the project.
The facility was delivered in 21 months, thanks to strong partnerships, staged permitting, close collaboration and robust safety measures.
A modular approach
To support flexibility, modularity and efficient operations, Denali selected a ballroom-style cleanroom design with single-use systems and scalable utilities. This open layout allows multiple unit operations within a single classified space, providing adaptability for different product types and production scales. The configuration simplifies material and personnel movement, reduces classified boundaries, and improves visibility, enhancing safety, compliance, and scalability. The facility was designed for phased growth with “future-ready” access points to major systems, like HVAC and water for injection (WFI).
The power of in-house manufacturing
In-house manufacturing is a powerful capability for a biotech company still in R&D. In this case, the move to in-house manufacturing unlocked wide-ranging flexibility, enabled greater exploration of R&D candidates, strengthened supply chain control, and enabled more efficient operations.
Denali’s manufacturing site benefits from several advanced technologies. The facility leverages a paperless, digital-first approach, enabling better process visibility, deeper troubleshooting insight, and rapid adaptation of R&D processes. Real-time data capture and integration enable continuous monitoring across equipment and batches.
In-house manufacturing also provides better controls over environmental factors and resource consumption. The WFI system selected uses ambient membrane-based technology rather than traditional WFI by distillation. This switch greatly reduces energy demand and provides a safer environment for operators.
The big picture
For CRB, this project represents more than a successful facility build. It reflects the impact of aligned vision, technical expertise and collaborative execution in bringing transformative therapies one step closer to the patients who need them. Denali’s new Salt Lake City manufacturing facility enables the company to further develop medicines for people with life-altering diseases.
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