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.
5823 Netwon Dr
Carlsbad, CA 92008
Phone: (760) 603-7200
Fact Sheet
cGMP plasmid DNA manufacturing capabilities
cGMP plasmid DNA manufacturing capabilities As the global plasmid market continues to grow rapidly, current and projected demand for high quality plasmid continues to be challenged by the availability...
Infographic
Critical quality attributes of plasmid DNA for advanced therapies
Plasmid DNA forms the genetic foundation for many therapeutic strategies, yet shifting market dynamics such as capacity constraints, potential operational disruptions due to company consolidations and acquisitions, and evolving regulatory guidelines can create complexities in developing a manufacturing strategy for this critical material. Download the following infographic for helpful insights on critical quality attributes impacting plasmid DNA.
Whitepaper
Leveraging innovations in plasmid manufacturing to bring advanced therapies to market
Download this whitepaper for insights on market trends influencing the supply of pDNA for advanced therapies, as well as manufacturing strategies to help accelerate timelines, mitigate risk and optimize clinical outcomes.
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Manufacturing strategies for plasmid DNA in advanced therapy applications
As the cell and gene therapy market continues to experience rapid investment and increased IND submissions, new questions arise regarding appropriate application of regulatory guidelines and manufacturing strategies for the critical raw materials used in the development of these ground-breaking treatments.
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