cGMP plasmid manufacturing services

Choose an end-to-end provider of commercial-quality cGMP Plasmid DNA that has the capacity and expertise to bring your cell and gene-based therapies to market without sacrificing critical timelines.

Rely on our manufacturing experience to ensure commercial-quality GMP plasmid DNA for cell and gene therapies right from the start—avoiding transitions in material quality and saving manufacturing time.

We have the capacity, manufacturing processes, analytical capabilities, and technical expertise that allows you to move quickly from clinical trials to commercial supply. Our state-of-the-art production suites in multiple manufacturing locations are dedicated to commercial-quality GMP plasmid production providing you shorter lead times and flexibility in manufacturing timelines when there are changes in your schedule.

We provide support at every stage with the expertise you need to bring your therapies to market faster because we know lives depend on it.

Why Thermo Fisher for cGMP plasmid DNA manufacturing?

Rapid execution from clinical to commercial with cGMP quality

Integrated offerings turn your discovery into a life-saving therapy

Expanded Capacity to Provide cGMP Plasmid DNA Manufacturing Services at Multiple Locations with State-of-the-Art Production Suites

Carlsbard, CA and Watertown, MA facility highlights:

  • Process Development
    • Plasmid vector selection
    • Cell line selection
    • RCB, MCB, WCB
    • Process and cell line optimization
  • QC and Analytical
    • Analytical method transfer and validation
    • Standard and custom analytical offerings for in-process release and MCB
    • Stability studies
  • cGMP Manufacturing
    • Clinical to commercial scale
    • 30L to 1000L single use process trains
    • Filling for critical raw material or drug substance
    • Storage in temperature controlled GMP warehousing
Thermo Fisher Plasmid DNA Manufacturing Site in Carlsbad, CA
Thermo Fisher Plasmid DNA Manufacturing Site in Carlsbad, CA

Let us put our technical expertise to work for you. We can help you with your plasmid DNA needs.

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