From DCAT Week: Thermo Fisher Scientific Outlines Multi-Segment Expansions 

Leon Wyszkowski,
President, Commercial Operations, Pharma Services
Thermo Fisher Scientific

Thermo Fisher Scientific is proceeding with a series of investments to expand capacity in cell and gene therapies, drug products, and biomanufacturing. Leon Wyszkowski, President of Commercial Operations, Pharma Services, Thermo Fisher Scientific, detailed the company’s recent expansions at the DCAT Member Company Announcement Forum held on March 20, 2023, at DCAT Week, and as outlined below.  

Cell and gene therapies. This month (March 2023), Thermo Fisher’s cell-therapy network expanded to include a new 44,000-square-foot cell-therapy development and cGMP manufacturing center adjacent to the University of California, San Francisco (UCSF) Medical Center’s Mission Bay campus. In this facility, Thermo Fisher offers UCSF and other customers process and analytical development capabilities, as well as clinical and commercial manufacturing services, for advanced therapies derived from either a patient’s cells or from a donor source.  

Also, this year (2023), Thermo Fisher will expand its Carlsbad, California, plasmids facility to expand process development and GMP operations, specifically at the 30-L and 300-L scales.  

Oral solid dose early-development hub. In April (April 2023), Thermo Fisher will open an early development hub at its site in Bourgoin, France, to provide early- and late-phase development at the same location, including integrated active pharmaceutical ingredient (API), solid-state analysis, drug-product development, clinical services, and regulatory support.  

Biologics. The company is expanding capabilities at its site in St. Louis, Missouri. to address the growing demand for biologics, including supporting manufacturing and production growth from 2,000 L to 5,000 L and adopting new technologies that enable higher yield.  

mRNA products. With a multi-year collaboration agreement to support Moderna’s therapeutics’ pipeline, which includes its COVID-19 vaccine among other potential vaccines and therapies in development, Thermo Fisher will provide dedicated capacity for a range of aseptic fill–finish services, including lyophilized and liquid filling, at its site in Greenville, North Carolina. In addition, the company will provide inspection, labeling and final packaging services. The first sterile vaccine fill line will begin operation this year (2023).  

Expansions in Asia-Pacific. Thermo Fisher recently opened an 86,000-square-foot cGMP facility in Hangzhou, China, its first integrated biologics drug-substance and sterile drug-product manufacturing site. From there, the company can support pharmaceutical and biotechnology companies in China, enhance access to China for companies outside that country, and make those capabilities available for global needs. Furthermore, Thermo Fisher will open its first site in Singapore later this year (2023) for large-scale commercial capacity and high-speed filling of vials, which will expand its global investment in vaccine capabilities.