On Dec. 15, the US firm based in New Jersey announced plans for a new cryocenter in Germany to provide cold chain support for clinical trials.  A day later, it said it would build a new plasmid DNA manufacturing facility at its Carlsbad, California, USA, to keep pace with demand in a market where demand has outstripped supply.

The new 890 m2 cryocenter at Weil am Rhein, in southern Germany near the European pharma hub of Basel, Switzerland, where Thermo Fisher Scientific has existing clinical services, will specialize in ultra-low-temperature, cryogenic storage and cold chain expertise. Among other things, this will be needed for the Pfizer-BioNTech Covid vaccine that must be kept at a temperature of minus 70°C before administering.

Alongside storage, the cryocenter scheduled to open early next year will handle packaging, labeling and distribution required by vaccine and cell and gene therapy innovators. The site will feature freezers with a temperature of minus 80°C, liquid nitrogen (LN2) cryogenic storage tanks and walk-in 2-8°C and minus 20°C cold storage technology.

The 8,000 m2 packaging, storage, logistics and distribution center at Rheinfelden, Germany, in the same region, is due to be completed by the end of December. This will significantly increase the CDMO’s footprint for secondary packaging, storage, logistics and distribution of clinical supplies to investigator sites across Europe.

 Featuring highly automated technology in a fully scalable, mixed-use space, the Rheinfelden site will serve as a strategic logistics hub for shipping by road or air, and its central location will facilitate distribution of clinical trial therapies to European patients.

Both of the German facilities will use innovative and highly automated technologies to optimize efficiency and quality across the pharma services supply chain, Thermo Fisher Scientific said. According to the European Medicines agency, the clinical supply chain and logistics market in Europe is expected to double by 2025 and more than triple by 2030.

Plasmid DNA center in California

Thermo Fisher’s investment at Carlsbad, where construction is due to be completed in the first half of 2021, is expected to create up to 150 jobs over the next year. The site will boost the company’s 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 capable of producing plasmid DNA as a primary drug substance for DNA therapies.

The California plant featuring single-use equipment capable of handling projects up to 1,000 liters will boast digital connectivity and data visibility to smooth operations and make training employees easier, the company said.

"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,” said Mike Shafer, senior vice president and president of pharma services.

Author: Dede Williams, Freelance Journalist