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