cGMP plasmid manufacturing services

Plasmid DNA forms the genetic foundation for many therapeutic strategies. The advancement of cell and gene therapies progressing rapidly from clinical research phases to commercial readiness as well as the rapid emergence of the mRNA vaccine market has created intense pressure on manufacturing of plasmid DNA. Thermo Fisher Scientific Patheon has responded to the call by expanding capacity and service offerings so you can get to market faster.

cGMP quality at all stages of development and commercialization

Starting with cGMP raw materials early on can help reduce timeline and clinical efficacy risk associated with transition of raw materials as well as reduce risk of repeat work due to inconsistent quality. Thermo Fisher Scientific Patheon’s plasmid DNA cGMP manufacturing and QC analytical capabilities ensure you get the quality material you need at all stages of development and commercialization.

Transparency to support regulatory approvals

Visibility into manufacturing processes, data, and batch records is critical in a regulated environment. Patheon places a high value on collaborative partnerships, so we strive to provide the visibility and support you need for your regulatory filings.

Capacity and flexibility to scale with you

Capacity is at a premium, and flexibility in cGMP facility design can help ensure your unique timeline and needs can be met. Our expanded capacity and flexibility partnered with a broad range of services from process development to cGMP manufacturing to storage, logistics, and distribution solutions, means Thermo Fisher Scientific Patheon’s plasmid DNA manufacturing capabilities can flex and scale with your changing needs.

  • 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

Let us put our technical expertise to work for you. We can help you with plasmid DNA manufacturing capacity and quality.

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