Gene Therapy Company

Laboratory Upfit

RTP, NORTH CAROLINA

Located on the client’s RTP campus, this multi-phase project supported their mission to address complex challenges in biotechnology, specifically gene therapy. To keep pace with evolving scientific needs, the client turned to 35 North due to our deep expertise in end-to-end services for life sciences organizations, particularly in the RTP area.

The client had several pain points with critical lab temperature control units (TCUs) for the refrigerators, freezers, and incubators – they were not being effectively monitored and alarmed by their Rees monitoring system. Our commissioning team executed an assessment across two sites and provided solutions to remediate all underlying issues. The scope was expanded to include commissioning services for a 23,758-SF laboratory upfit, as well as move management and project management services during the build-out of Good Laboratory Practice (GLP) laboratory spaces.

The laboratory upfit encompassed two floors and featured gene therapy lab suites dedicated to quality control, product development, and cell culture. Facility upgrades also included the lobby entrance, compressed air system, and a new RODI system.

35 North’s Role:

As part of the renovation effort, 35 North provided project management oversight of construction activities supporting multiple departments, including analytical development, quality control, DNA, MSAT, product development, solutions prep, pilot lab, buffer prep, cell culture, formulation, and sample receipt.

Move management services included planning and executing the relocation of existing and new laboratory casework and equipment. A comprehensive tagging and labeling strategy, combined with the use of temporary storage solutions, enabled the project team to meet an aggressive timeline.

Relocated equipment included bioreactors, XCell ATF cell retention systems, TECAN automation systems, triple-stack incubators, PendoTech control systems, AKTA Avant chromatography systems, protein analyzers, centrifuges, and biosafety cabinets.

35 North also coordinated third-party decommissioning efforts to ensure minimal disruption to ongoing laboratory operations. The final phase of the move included installation and operational readiness of lab benches and critical equipment.

Lastly, our commissioning efforts extended to systems such as air handling and exhaust, the new RODI skid, electrical distribution, lighting, telecom, security, laboratory water and waste systems, laboratory gases (CA, CO₂, O₂), fire protection, and environmental monitoring. Comprehensive commissioning services included support with calibrations and CMMS efforts as well.

We’re excited to partner with you! Our business consulting services and expertise in construction and project management are second to none. Our success is driven by the decisions we make, the policies we implement, and how our employees are trained.