Thermo Fisher Scientific Constructs Medical Manufacturing Complex in Carlsbad, California
The site will expand the company's clinical and commercial capabilities for cGMP plasmid DNA used as a critical raw material to develop and manufacture cell and gene-based therapies including life-saving cancer treatments as well as mRNA vaccines. In addition, the site will have the capability 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," said Mike Shafer, senior vice president and president, pharma services, Thermo Fisher.
According to company officials, as the global plasmid market continues to grow rapidly, the global supply cannot meet the current and projected demand. The 67,000-square-foot facility, expected to be completed in the first half of 2021, will feature advanced technologies, including single use equipment with up to 1,000L scale, digital connectivity and data visibility to enable operational efficiencies and operator training.
"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, from research and preclinical development to clinical and now expanded commercial and supply chain services," Shafer added.
This expansion builds on the company's continued investment in cell and gene therapy services. Customers can leverage its fully integrated development and manufacturing capabilities, including viral vector services in Cambridge, Lexington and Plainville, Massachusetts, and Alachua, Florida; a new cell therapy manufacturing facility in Princeton, New Jersey; and, a new dedicated cryocenter in Weil am Rhein, Germany to provide specialized cryogenic and cold chain supply chain services to support clinical trials across Europe and globally.
"Carlsbad is proud of its leadership in life sciences with our long history and rich talent base," said Carlsbad Mayor Matt Hall. "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."
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