Denali Therapeutics

This clinical biomanufacturing facility supports regulated production activities for a leading biotechnology company advancing therapeutics for neurodegenerative and lysosomal storage diseases. The ~60,000 SF facility in Salt Lake City was developed to enable in-house manufacturing for clinical and investigational programs, strengthening supply chain control and operational readiness in support of expanded drug development and future commercialization pathways.

CM&D served as Owner’s Advisor, coordinating multidisciplinary teams and managing design and construction activities within a regulated manufacturing environment. Our work focused on aligning process requirements, MEP and utility systems, and construction sequencing to support both compliance and operational throughput. The project required integration of specialized manufacturing infrastructure, cleanroom environments, and utility systems capable of sustaining regulated production activities while facilitating efficient commissioning and turnover in a highly technical facility.

Key project challenges included navigating phased build-out requirements tied to clinical program timelines, coordinating infrastructure delivery to match regulatory and production readiness milestones, and supporting owner-driven decisions related to facility utilization and scalability. By ensuring continuous alignment between design intent, construction execution, and operational objectives, the project was positioned for reliable delivery within defined schedule and quality parameters.