Project GTx: Commissioning and Equipment Verification
Cell & Gene Therapy
Overview
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.
Sequence Scope: Equipment Verification
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.
Life Impact
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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
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This includes gene therapy for Duchenne Muscular Dystrophy. Press Release
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Why is Equipment Verification so critical to the Life Sciences Industry?
The pharmaceutical and life sciences industries manufacture important products that affect the life and well being of their customers. Equipment to manufacture these products is a vital component of delivering quality, reliable products. The verification of equipment and validation of process ensures the quality of a product by having an independent set of procedures to check that the specifications and requirements for that product are met consistently. The verification and validation documentation is critical in ensuring that equipment is fit for intended use while producing products focused on product quality and patient safety. Regulatory agencies, like the FDA, require equipment verification and process validation prior to achieving licenses to manufacture commercial products.