Pfizer Durham NC clinical manufacturing facility

Project Inspire - Durham Clinical Manufacturing Facility

We approach our work from a Whole Facility Design Perspective, resulting in elegant, efficient engineering solutions that are practical and reliable, maximizing your long term benefit from your facility.

Challenge

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. 

Solution

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.

Results

Our team accomplished the following:

  • Delivered a fully qualified, large-scale GMP manufacturing facility.
  • Reassessed and met critical deadlines despite storm-related setbacks.
  • Ensured safety compliance to support clinical trial production.

Partial Project Team

Keith-Sheldon
Keith Sheldon, QCxP
Senior Commissioning Engineer
Chris Giusto
Chris Giusto
Regional Manager - South Atlantic Director - Combustible Dust Safety
Chris_Dunlap
Chris Dunlap, PE
Senior Mechanical Engineer
John Edgar400x400
Jon Edgar, PMP
Cx & Validation Team Lead
Bill Deyncourt
Bill Deyncourt
Cx & Validation Associate
Zack_Baldwin
Zack Baldwin
Mechanical Engineer
eric_fagerman400 x 400-1
Eric Fagerman
Senior Mechanical Designer
will caruthers 400 x 400
Will Caruthers
Mechanical Engineer