Project Inspire - Durham Clinical Manufacturing Facility

Durham, NC

Biotech & Pharmaceutical 

Pfizer was planning to retrofit an existing one-story 85,000 sf building in Durham, NC. The renovated first floor provided manufacturing suites, laboratories, offices, support spaces, and utility rooms. The second floor of approx. 20,000 sf was newly constructed within the existing building shell to provide additional office and mechanical space. Pfizer’s goal was to have adequate space to provide safe and effective drugs and treatments resulting in higher quality of life for those suffering from rare, treatable disease processes.

As part of the retrofit, Pfizer created a new Good Manufacturing Practice (GMP) compliant Biosafety Level 2 Large Scale facility that was designed to produce gene therapy drug substance and drug product for Phase I/II clinical trials. This $68.5 million facility has the capability to support multiple products through two drug substance production suites and one drug product suite. 

Hallam-ICS was brought on board to provide commissioning and qualification for the systems and equipment. We provided documented testing and verification that will support Pfizer’s need for a facility, systems, equipment, and instruments that are suitable for the intended purpose and are compliant with current Good Manufacturing Practices (cGMP).

One of the biggest challenges was presented by a severe storm that caused damage to the building.  Much work had to be completed to remediate the damage and to ensure the facility was safe to continue with the intended use. This came at a time when many concurrent validation efforts were still underway. The schedule for the remaining qualification work had to be reassessed as critical in addition to performing any re-qualification needed as a result of the storm damage. Despite this complication, Hallam-ICS demonstrated the ability to complete a quality commissioning and qualification end product for a large-scale cGMP manufacturing facility.