GMP Data Integrity Assessment & Remediation
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: Data Integrity Assessment
This cross functional project involved in-depth DI assessment effort for more than 74 system types in the lab and manufacturing space (Isolators, Autoclaves, Media Prep Vessels, Balances, Scales, Thermocyclers, Glass Washer, SoloVPE, Karl Fisher, Centrifuges, Osmometer, Spectrophotometer, BioAnalyzer, etc.) Each system was evaluated to determine an adequate remediation plan (if necessary). The necessary remediation effort was addressed, and the project was successfully completed on schedule and under budget within an aggressive timeline.
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 These life saving therapies required strict GMP data integrity practices.
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 meningitidis types A, C, W-135 and Y. Source