StemCell Therapy

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Thermo Fisher Scientific has been as busy as Santas elves this December. The company is significantly expanding its footprint with new facilities in the United States and in Europe.

This week, the company announced it started construction of a new cGMP plasmid DNA manufacturing facility inCarlsbad, Calif.This expansion builds on the company's continued investment in cell and gene therapy services. 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 California site will span 67,000 square feet and is expected to be completed in the first half of 2021. The facility 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, the company said. 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, Mike Shafer, senior vice president and president of pharma services at ThermoFisher said in a statement. 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.

Shafer said Thermo Fisher is making strategic investments in capacity, technology and expertise across its global network so the company can accelerate innovation and enhance productivity for its customers.

The California site isnt the only expansion the company is undertaking. To meet accelerating demand for robust clinical supply chain services throughout Europe, Thermo Fisher Scientific has expanded its pharma services footprint with two new facilities inRheinfeldenand Weil am Rhein, Germany. The new sites will boost clinical supply chain continuity and specialized cold chain and cryogenic expertise across Europeand globally.

TheRheinfeldensite opens in late December 2020 and the Weil am Rhein site will open in January 2021.InRheinfelden, the new 86,000-square-foot/8,000-square-meter facility significantly increases the company's footprint for secondary packaging, storage, logistics and distribution of clinical supplies to investigator sites across Europe. In Weil am Rhein, the new 9,600-square-foot/890-square-metercryocenterprovides specialized ultra-low-temperature, cryogenic storage and cold chain expertise for clinical supply chain needs for cell and gene-based therapies, including COVID-19 vaccine candidates.

These facilities combined with our established regulatory expertise will give customers the continuity and in-region capabilities to support clinical trials across multiple therapy areas, Shafer said.

In addition to the construction of new facilities, earlier this month, Thermo Fisher announced the expansion of several of its existing sites that will increase the companys capabilities for sterile drug product development and commercial manufacturing of critical medicines, therapies and vaccines.

Thermo Fisher is expanding its facilities in Greenville, N.C., Swindon, England and two sites in Italy, Ferentino and Monza. Not only will the expansion of these facilities boost commercial production lines and support capabilities for aseptic liquid and lyophilized vial filling, but the projects will also add approximately 1,000 new jobs. The expansions are expected to be completed over the next two years, Thermo Fisher said in its announcement.

In addition to expansions inNorth AmericaandEurope, the company recently announced significant projects inAsia-Pacific, including a new sterile manufacturing facility inSingaporeand a new integrated biologics and sterile drug development and manufacturing site inHangzhou, China.

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Thermo Fisher Invests in Gene Therapy Future with Huge Expansions - BioSpace

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