ThermoFisher Scientific Patheon Pharma Services
×
Recent searches Clear History
Suggestions
All Results
 Search
 US | EN

cGMP plasmid DNA development and manufacturing services

De-risk your path to commercialization with flexible plasmid solutions backed by proven quality systems

Plasmid DNA forms the genetic foundation for many therapeutic strategies, and the growth of cell and gene therapies as well as the rapid emergence of the mRNA vaccine market has created intense pressure on manufacturing of this critical material. Thermo Fisher Scientific has responded by expanding our plasmid DNA capacity and service offerings so you can discover the right solution to meet your unique requirements and get to market faster.

Solutions for a variety of plasmid DNA applications

We produce plasmid DNA for a wide variety of R&D, clinical, and commercial bioprocessing applications, including:

  • Starting material for viral vector manufacturing
  • Plasmid as a drug substance or drug product
  • Linearized plasmid for mRNA synthesis
  • Nanoplasmid manufacturing

Plasmids can be manufactured by leveraging our proven platform process or via a customized production process for your unique molecule to improve efficiency of performance and scale up as needed.

Flexible scale options to support your unique project needs

As quantity requirements vary based on plasmid application and development stage, we’re pleased to offer flexible scale options to support your unique project needs throughout the product lifecycle.

Bioreactor size
Working volume range
30 L
10 – 30 L
300 L
60 – 300 L
1000 L
600 – 1000 L

Phase-appropriate service to meet both cost and quality goals

Raw material quality issues create an increased risk of CMC holds and can threaten project timelines while adding unnecessary costs. With Thermo Fisher’s phase-appropriate service, you don’t need to wait to implement cGMP plasmid into your advanced therapeutic manufacturing process. Our approach includes access to full cGMP-quality plasmid material regardless of clinical phase of development. This is unique from other providers that offer “cGMP-like” plasmids not made to full cGMP standards for use as starting materials for advanced therapies.

  • GMP-Now™ Plasmid DNA

    • Plasmid produced with full application of cGMP practices with standard documentation provided; pricing competitive with cGMP-“like” materials.

  • cGMP Plasmid DNA

    • Plasmid produced with full application of cGMP practices and enhanced traceability and/or customized documentation available for an additional fee.

Comprehensive plasmid DNA CDMO capabilities from clinical to commercial

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 our plasmid DNA capabilities can flex and scale with your changing needs across the product lifecycle.

 
 
 
  • Research cell banking

    •  

  • Process development and optimization runs in Ambr system, 3L and 30L scales

    •  

  • Analytical method development
      
     
Process and analytical development

 

  • Analytical method qualification and validation

    •  

  • Standard analytical offering for MCB, in-process testing and plasmid release

    •  

  • GMP standard for clinical and commercial

    •  

  • Stability studies
Quality control and analytical testing
  • Clinical to commercial

    •  

  • Single-use process train at 30L, 300L, and 1000L

    •  

  • Significant expansion potential

    •  

  • Master and working cell banking

    •  

  • Storage in temperature-controlled GMP warehouse
Plasmid cGMP manufacturing

Technology transfer is often associated with risks that may affect costs and timelines. To circumvent these challenges, we employ a methodical and risk-based tech transfer approach leveraging 30+ years of Patheon manufacturing experience. Our teams are well-versed in all aspects of tech transfer including scaling, moving projects between facilities, and transferring external processes into our facilities. We can execute the transfer quickly and effectively to keep your project on track and preserve supply. Our flexible approach is driven by your deadlines, and we’re dedicated to getting the job done right the first time.

 
  • Standardized tech transfer across sites
  • Multidisciplinary project team with experience managing 200+ transfers to date

  • Clear line of sight from process development through cGMP

  • Risk management tools to identify and mitigate risks

  • Process simulation modeling available

  • Compartmentalized area for staging and prepping

  • Follow Technology Transfer Protocol (TTP)
    • Document all key process details
    • Criticality ranking
    • Updated as process moves through clinical manufacturing and converts into process control strategy for PPQ

The regulatory landscape for advanced therapies is constantly evolving, and what’s acceptable today may not be adequate tomorrow. For over 15 years we have supported customers with global regulatory interactions (US, EU, and Canada), CMC regulations, guidelines, and inspections. In addition to providing document reviews and gap analyses, our regulatory services team can generate documents to reduce the number of intermediaries and lead times in preparing regulatory filings.

 
  • CMC dossier writing

  • Gap analysis and CMC dossier review

  • CMC regulatory strategic consulting

  • Health authority meeting, filing, and inspection support

  • Familiarity with shifting regulatory guidelines

 

View our infographic on critical quality attributes for plasmid DNA and the latest regulatory guidance.

 

Visit our cGMP plasmid DNA manufacturing site in Carlsbad, California

 

Our 67,000 sq ft facility located in Carlsbad, California has the capacity now to address your unique plasmid project needs. The process development space was recently expanded for improved throughout and additional small-scale capabilities. Our facility is also licensed by the state for drug substance production.

Helpful Resources