Thermo Fisher Scientific is shoring up production of cell and gene therapies on both sides of the pond, a move it hopes will support the development of COVID-19 drugs and vaccines—and ensure supplies are in place should they pass muster with regulators.
The New Jersey contract manufacturer is laying out a new plasmid DNA manufacturing facility at its Carlsbad, California, campus, aiming to boost its cell and gene therapy offerings against the backdrop of a global plasmid market where demand has quickly outpaced supply, the company said.
That’s on top of plans for a new cryocenter in Germany. That site, one of two new German facilities set to come online in the next few weeks, will offer cold chain support for clinical trials of cell and gene therapies, including COVID-19 vaccine hopefuls, in Europe and beyond.
The 67,000-square-foot Carlsbad facility will add some 150 jobs over the next 12 months, with construction pegged to wrap in the first half of 2021, Thermo Fisher said. The site will boost clinical and commercial output of plasmid DNA used to develop and produce cell and gene therapies for cancer, as well as mRNA vaccines. It will also be equipped to churn out large-scale plasmid DNA as a primary drug substance for DNA therapies, the company said.
The facility will be kitted out with single-use equipment capable of handling projects up to 1,000 liters and will boast digital connectivity and data visibility to smooth operations and make training employees easier, Thermo Fisher said.
Thermo Fisher is no stranger to the field, with a cell and gene therapy footprint in Massachusetts and Florida, plus a newly minted cell therapy manufacturing plant in Princeton, New Jersey—but it figures the expanded commercial and supply chain services at its Carlsbad site will smooth the wrinkles in the current plasmid market.
"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, SVP and president of pharma services at Thermo Fisher, said in a release.
"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.”
A day before Thermo Fisher sketched out its Carlsbad plans, the company announced a twin pharma services expansion in Europe. First up for completion in late December is an 86,000-square-foot packaging, storage, logistics and distribution center in Rheinfelden, Germany, which will serve as a strategic logistics hub for European clinical trials.
Then there’s Thermo Fisher’s 9,600-square-foot cryocenter in Weil am Rhein, Germany, set to go live in January 2021. That site, poised to support super-cold storage of experimental cell and gene therapies, including vaccines, will boast minus 112 degrees Fahrenheit freezers, liquid nitrogen storage tanks and walk-in storage as cold as minus 4 degrees Fahrenheit.
Aside from supporting trials of cell and gene therapies against COVID-19, Thermo Fisher in September teamed up with Humanigen to help the California biotech scale up production of its clinical-stage cytokine storm hopeful, lenlizumab. That deal marked Humanigen’s third tie-up for its monoclonal antibody on the heels of manufacturing pacts with Lonza and Catalent.
Elsewhere, Thermo Fisher in October drew up plans for a new, $130 million Singapore facility that will house two sterile filling lines, expected to eventually crank out 30 million drug and vaccine doses per month, the CDMO said.