Executive analysis, grounded insights and community-focused efforts.

This project addressed the unique requirements of UNC Lineberger’s Advanced Cellular Therapy program within a preoccupied building, presenting challenges related to limited deck height for overhead infrastructure installation. The project encompassed the development of office support space along with featuring current Good Manufacturing Practice (cGMP) ISO 7 and ISO 8 cleanrooms.

Key components of the project included the establishment of a new exterior equipment yard housing generators, chillers, boilers, and a vacuum pump skid to meet the specialized needs of the new laboratory facilities. Process piping was intricately piped through custom stainless utility chases to optimize functionality and ensure seamless operations.

Lab filtration, a critical aspect of the project, involved the integration of stainless steel Ultra-Low Penetration Air (ULPA) fan filter packs and stainless-steel low-wall returns, aligning with the rigid standards required for cleanroom environments.

To enhance construction efficiency and facilitate future maintenance, the project team implemented extensive Building Information Modeling (BIM) coordination during the preconstruction phase. This meticulous planning process ensured the ease of maintaining the overhead infrastructure and addressed the challenges posed by limited deck height and contributing to the long-term sustainability of the facility.

This project demonstrated a strategic and innovative approach to meet the requirements of UNC Lineberger’s Advanced Cellular Therapy program within an already occupied space. The inclusion of specialized cleanroom facilities, support for external equipment, and meticulous Building Information Modeling (BIM) coordination provided a dedicated commitment to the School of Medicine’s and UNC Lineberger researchers’ excellence in research and development, all while navigating the challenges of a complex building environment.
Facility features include:
• Dedicated virus production clean room suite with negative pressure HVAC system.
• Central supply of CO2, air, and vacuum to multiple points in each clean room suite.
• T-Cell Therapy production rooms equipped with Class II(A2) biologic safety cabinets and CO2 incubators.
• Equipment for specialized oncology, immunotherapy, and clinical trial procedures (e.g., CliniMACS cell immunomagnetic cell separator).
• Building and equipment monitoring systems providing 24/7 data capture with local and remote alarming.
• Controlled environment material management storage areas.
• Monitored, controlled access product storage room with a range of storage conditions, including vapor phase liquid nitrogen freezers and ultralow-temperature mechanical freezers.
• Process development area for translation and cancer care scale-up work.