The new cGMP facility in Carlsbad, California would expand the commercialisation of plasmid-based medicines and vaccines
Thermo Fisher Scientific headquarters in Waltham, MA. (Credit: Thermo Fisher Scientific Inc.)
Thermo Fisher Scientific has announced the expansion of its commercial and clinical manufacturing capabilities for cGMP plasmid DNA with a new manufacturing facility in Carlsbad, California.
The 67,000ft2 new commercial facility will be constructed on the Carlsbad campus of Thermo Fisher’s centre of excellence for life sciences solutions.
The construction is expected to be completed in the first half of 2021, and is estimated to add nearly 150 jobs in the coming 12 months.
Thermo Fisher said that Carlsbad has been strategically selected to benefit from its long-term presence in the region and tap on the strong talent pool.
Carlsbad Mayor Matt Hall said: “Carlsbad is proud of its leadership in life sciences with our long history and rich talent base.
“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.”
cGMP plasmid DNA is used for cell and gene-based therapies, and vaccines
The new facility is designed to 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.
cGMP plasmid DNA is used as a critical raw material for developing and manufacturing cell and gene-based therapies, including cancer treatments and mRNA vaccines.
Thermo Fisher said that its expansion builds on its continued investment in cell and gene therapy services. The new site will produce large-scale plasmid DNA as a primary drug substance for DNA therapies.
Furthermore, customers can use the company’s fully integrated development and manufacturing capabilities.
The company offers viral vector services in Cambridge, Lexington and Plainville, Massachusetts, and Alachua, Florida.
In addition, it has a new cell therapy manufacturing facility in Princeton, New Jersey, and a new dedicated cryocenter in Weil am Rhein, Germany to offer specialised cryogenic and cold chain supply chain services for clinical trials.
Thermo Fisher pharma services senior vice-president and president Mike Shafer said: “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.
“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 commercialisation – from research and preclinical development to clinical and now expanded commercial and supply chain services.”