Thermo Fisher Expands Plasmid DNA Mfg. Capabilities

Thermo Fisher Scientific is constructing a new cGMP plasmid DNA manufacturing facility in Carlsbad, CA. 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 cancer treatments and 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 67,000-square-foot facility, expected to be completed in 1H21, 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.

Located on the Carlsbad campus of Thermo Fisher's center of excellence for life sciences solutions, the new commercial facility will add approximately 150 jobs over the next 12 months.

"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. "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."