Carlsbad, California, USA

Plasmid DNA development and manufacturing facility

Thermo Fisher Scientific’s state-of-the-art facility in Carlsbad is designed for commercial manufacturing and is licensed by the state of California for drug substance production. This 67,000 sq. ft. site is equipped to support a variety of plasmid application areas, including plasmid as a starting material and plasmid as a drug substance or drug product. Additionally, the process development lab space recently expanded for improved throughput and additional small-scale capabilities, and rapid expansion of GMP fermentation capacity is available based on customer needs.

 

Capabilities

  • Solutions for plasmid as a starting material for viral vector manufacturing, plasmid as a drug substance or drug product, and linearized plasmid for mRNA synthesis
  • Flexible scale options including 3L (RUO only), 30L, 300L, and 1,000L
  • Process transfer, development, and optimization
  • Master/working cell banking
  • Scale-up to GMP for clinical and commercial manufacturing
  • In-process and release testing
  • Stability testing and storage
  • Plasmid platform and custom process support available
  • Phase-appropriate service includes access to full cGMP-quality plasmid material with the option for enhanced traceability and/or customized documentation
  • Potential to expand based on customer needs

5823 Netwon Dr
Carlsbad, CA 92008
Phone: (760) 603-7200

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