Sequence announces our new website and logo

Read
All Projects

Site Data Integrity Assessment & Remediation

Vaccines, Cell & Gene Therapy

Overview

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

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.

Life Impact

  • 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 meningitidis types A, C, W-135 and Y. Source

Get Started

How can we support your project success?

Contact Us
855.844.7171 info@sequenceQCS.com
  • Global Headquarters
    2100 Gateway Center Blvd, Suite 301
    Morrisville, NC 27560

  • Lab and Training Center
    2500 Gateway Center Blvd, Suite 850
    Morrisville, NC 27560

  • Northeast Office
    1 Speen Street, Suite 120
    Framingham, MA 01701

Sign up for our email newsletter

Accelerating time to market through proven quality and compliance solutions.

© 2021 Sequence, Inc. All rights reserved.