Thermo Fisher to build new California plasmid DNA production site, expands pharma services and sterile drug manufacturer footprint in EU and US

The site will expand the CDMO'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 as well as mRNA vaccines.

In addition, Thermo Fisher said the site will have the capability to produce large-scale plasmid DNA as a primary drug substance for DNA therapies. As the global plasmids market continues to grow rapidly, this expansion will provide much needed capacity to the industry, it confirmed.

The 67,000-square-foot facility, expected to be completed in the first half of 2021, is set to include single use equipment with up to 1,000L scale, digital connectivity and data visibility to enable operational efficiencies and operator training. 

Meeting cold chain storage and clinical supply chain needs 

This news comes on the heels of additional expansions to the CDMO's pharma services footprint in the past week, including two new state-of-the-art clinical supply and specialized cold chain storage facilities in Rheinfelden and Weil am Rhein, Germany as well as investments at five of its sites across North America and Europe for sterile drug product development.

The new Rheinfelden site, said Thermo Fisher, consists of an 86,000-square-foot facility that will increase 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 cryocenter will provide 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, it added. The site will feature -80°C freezers, liquid nitrogen (LN2) cryogenic storage tanks and walk-in 2-8°C and -20°C cold storage technology.

The sites are set to open in December 2020 and January 2021, respectively. 

Both facilities are strategically located in the Baden region of Germany and in close proximity to the company's existing clinical services sites in Basel, Switzerland, and Horsham, UK, as well as to its dedicated cell and gene therapy facilities in Bishop's Stortford and Stevenage, UK, said Thermo Fisher. 

Addressing demand for injectable sterile drugs​

The company also announced on December 9 that it would further expand its footprint in North America and Europe for sterile drug product development and commercial manufacturing of critical medicines, therapies and vaccines. 

“We have continued to invest strategically in capacity, technology and expertise across our global network so we can accelerate innovation and enhance productivity for our customers,”​ said Mike Shafer, senior vice president and president, pharma services, Thermo Fisher Scientific. “This has enabled us to respond quickly and support our customers with unprecedented scale and depth of capabilities to meet high demand for new therapies and vaccines. By simplifying the supply chain and solving complex manufacturing challenges, we shorten development timelines in order to get high-quality medicines to patients, faster.”​

Among its sites up for expansion are Greenville, North Carolina, in the US, Swindon in the UK as well as Ferentino and Monza in Italy.

These investments will add 15 development and cGMP commercial production lines, supporting a range of capabilities including live virus, aseptic liquid and lyophilized vial filling, said the company. Those projects are expected to be completed over the next two years and will create approximately 1,000 jobs.

In addition to expansions in North America and Europe, the company recently announced significant projects in Asia-Pacific, including a new sterile manufacturing facility in Singapore and a new integrated biologics and sterile drug development and manufacturing site in Hangzhou, China. 

"With these investments, we’ve nearly doubled our global footprint for drug development and commercial manufacturing, which allows us to support our customers with unmatched flexibility, expertise and scale at a time of unprecedented demand,"​ added Shafer.

The activities underscore the rapidly growing global demand for injectable sterile drugs, which comprise 46% of the total dosage forms securing US FDA approval in 2019 compared to 25% a decade ago, reported Thermo Fisher, citing PharmaSource, a healthcare marketing company, and the FDA.