Thermo Fisher Scientific has announced the construction of a cGMP plasmid DNA manufacturing facility in Carlsbad, Calif.
The site will expand the company's clinical and commercial capabilities for cGMP plasmid DNA used as a raw material to develop and manufacture cell and gene-based therapies including cancer treatments as well as mRNA vaccines. The site will also be able to produce large-scale plasmid DNA as a primary drug substance for DNA therapies.
The 67,000 sqft facility, expected to be completed in the first half of 2021, will feature single use equipment with up to 1,000 L scale, digital connectivity and data visibility to enable operational efficiencies and operator training.
"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 VP and President, Pharma Services, Thermo Fisher. "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."
Located on the Carlsbad campus of Thermo Fisher's centre of excellence for life sciences solutions, the facility will add approximately 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 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."