Project GTx: Commissioning and Equipment Verification
Cell & Gene Therapy
The Pfizer Sanford site is home to the state-of-the-art gene therapy manufacturing facility, which provides the ability to produce and supply both clinical and commercial scale quantities of critical life-changing gene therapy medicines to patients living with rare diseases around the world.
This project involved a full C&Q scope for Gene Therapy Equipment Verification which included the facilities, utilities, equipment, computerized systems, and labs. Sequence was responsible for developing the CQV strategy and planning, developing requirement specifications, and all CQV deliverables to demonstrate the facility was fit for intended use to produce potentially life-changing gene therapy products.Facility included Incubators, GE XDR Bioreactors, GE Wave Rockers, Perfusion Skids, GE Chromatography Skids, Filtration Skids, Bio-waste systems, Autoclaves, Buffer Prep, Biosafety Cabinets, Isolators, Fillers, and supporting utilities.
By expanding its manufacturing footprint in Sanford, Pfizer expects to strengthen its ability to produce and supply both clinical- and commercial-scale quantities of critical, potentially life-changing gene therapy medicines to patients living with rare diseases around the world. Specifically, the new facility helps advance Pfizer’s work in manufacturing highly specialized, potentially one-time gene therapies that use custom-made recombinant adeno-associated virus (rAAV) vectors. Source
This includes gene therapy for Duchenne Muscular Dystrophy. Press Release