Laboratory Equipment Qualification & Validation
Vaccines, Cell & Gene Therapy
The Pfizer Sanford, NC facility is responsible for manufacturing components for the company’s vaccine portfolio, including Prevnar 13. In addition, 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 for Laboratory Equipment Qualification
This project has been an on-going partnership with the client to support a risk-based validation strategy for efficient equipment qualification and validation of laboratory equipment and computerized systems. The project has included development of CQV project plans and development and/or execution of full life cycle documentation (URS, FS, Risk Assessments, IQ, OQ, PQ, Trace Matrices, Summary Reports, Operational and Administration SOPs) for more than 100 Lab Instruments and Equipment. The continued partnership has resulted in many successful projects and opportunities.
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
In addition, the Pfizer facility produces Nimenrix which is a conjugate vaccine that helps to provide protection against invasive disease caused by the bacteria Neisseria meningitis types A, C, W-135 and Y. Source