Thermo Fisher Breaks Ground on Plasmid DNA Manufacturing Facility

Thermo Fisher Scientific recently announced the construction of a new cGMP plasmid DNA manufacturing facility in California to expand the company’s efforts in gene and cell therapy development, including cancer treatments and mRNA vaccines. 

The DNA manufacturing facility will expand the company’s clinical and commercial capabilities for cGMP plasmid and DNA, which are used as a critical raw material. Additionally, the site will help to produce large-scale plasmid DNA as a primary drug substance for DNA therapies.

"The race to develop new transformative cell and gene therapies and vaccines is outpacing supply of commercial-quality plasmid DNA that can be produced at scale," Mike Shafer, senior vice president and president of pharma services at Thermo Fisher Scientific, said in the announcement. 

"Our new state-of-the art site will not only tackle the supply bottleneck for our customers, but also uniquely positions us to deliver robust, end-to-end cell and gene therapy capabilities. Our customers can leverage our deep industry knowledge and expertise in the complexities of cell and gene therapy at all points along the pathway to commercialization,” Shafer continued. 

Thermo Fisher Scientific stated that the facility will build on the company’s investment in cell and gene therapy services, as well as ensure customers can leverage development and manufacturing capabilities.

These capabilities include viral vector services in Cambridge, Lexington, and Plainville, Massachusetts, Alachua, Florida, a new cell therapy manufacturing facility in Princeton, New Jersey, and a new dedicated cryocenter in Weil am Rhein, Germany. 

The cryocenter will provide specialized cryogenic and cold chain supply services to support clinical trials across Europe and Germany, Thermo Fisher Scientific stated.

The cGMP plasmid DNA manufacturing facility will be located at Carlsbad, California, where Thermo Fisher Scientific has a center of excellence for life science solutions. The location will enhance the company’s presence in the region and utilize the robust talent pool.

In total, the facility will add nearly 150 jobs over the next 12 months. 

"Carlsbad is proud of its leadership in life sciences with our long history and rich talent base," said Matt Hall, Mayor of Carlsbad.  

"Thermo Fisher has been an exceptional partner in our community and we are pleased they continue to invest in and build their presence, not only for the economic development and opportunity it brings to the region, but also for the innovations they are developing to improve global health and medicine,” Hall continued.

Cell and gene therapy introduces stem cell populations into patients with chronic diseases, such as cancer, to replace diseased cells with healthy ones. 

Currently, there are 362 investigational cell and gene therapies in clinical development, a 20 percent increase from 2018, according to a recent report from Pharmaceutical Research and Manufacturers of America (PhRMA).

So far, gene and cell therapy development has centered on cancer, eye diseases, and rare hereditary diseases. 

Back in May, Thermo Fisher Scientific announced the launch of a $180 million commercial manufacturing site to more than double the company’s commercial viral vector capacity and support increasing demand for the development and manufacturing of cell therapies and vaccines.

The project will complement Thermo Fisher Scientific’s recently expanded capacity in Massachusetts and Florida, with the new Massachusetts-based manufacturing site slated to leverage digital connectivity and capabilities to enable operational efficiencies, high quality, data visibility, and advanced operator training.

The project will add over 200 jobs and is expected to be completed in 2022. 

At the end of July, Thermo Fisher Scientific and Lyell Immunopharma also partnered to develop manufacturing processes to create more effective cell therapies to benefit cancer patients.

The company’s main goal is to improve the fitness of T cells and obtain access and insights into emerging and existing technologies. This will help boost the robustness and consistency of manufacturing operations, the announcement said.