Duke University Medical Center Pediatric Blood & Marrow Transplant Center Case Study

GMP Consulting for a Pediatric Transplant Expansion and Manufacturing Facility

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Built EnvironmentBuilt Environment

Industry

Hospitals & Medical Centers

Location

North Carolina

The Duke University Medical Center Pediatric Blood & Marrow Transplant Program expansion combined renovation and new facility development to support both patient care and GMP manufacturing. The project included a new manufacturing facility alongside specialized isolation rooms and treatment areas serving an immunocompromised patient population. WorkingBuildings, a Trinity Consultants team, provided comprehensive GMP consulting focused on the design, construction, and qualification of a fully GMP-compliant environment, with close attention to the HVAC, life safety, and critical power systems supporting these highly controlled spaces.

Vision

The project was designed to expand Duke’s Pediatric Blood & Marrow Transplant Program while introducing a GMP manufacturing facility within the broader medical center. That vision required highly controlled environments that could support both sterile manufacturing and sensitive clinical care, with reliable HVAC, life safety, and critical power systems serving isolation rooms, treatment areas, and the new manufacturing center.

Partnership

WorkingBuildings supported the project with comprehensive GMP consulting spanning design, construction, and qualification. The team’s role focused on helping verify that the specialized environmental systems serving the facility were properly designed and implemented to meet GMP requirements and support the performance expectations of this complex healthcare setting.

Services Performed

WorkingBuildings, a Trinity Consultants team, provided GMP consulting for Duke University Medical Center’s Pediatric Blood & Marrow Transplant expansion, supporting design, construction, and qualification of compliant environments. The team verified HVAC, life safety, and critical power systems to ensure reliable performance for both patient care and sterile manufacturing operations.

Results

WorkingBuildings helped structure and optimize the design process in a way that reduced the total required construction space, supporting cost control without compromising function. The team also provided GMP qualification services intended to support regulatory compliance and readiness for manufacturing operations. With involvement extending from programming through long-term support, WorkingBuildings helped keep the facility’s complex systems aligned with the operational needs of both the Pediatric Blood & Marrow Transplant Program and the manufacturing pipeline.

The community noted how the monitoring program was an effective tool to manage expectations and expressed their gratitude for all of your hard work and attention to detail on the project.

Emily Emrick | Shalom Baranes Associates
Senior Principal