News from DCAT Week 2022: Thermo Fisher Investing in Advanced Therapies, Biologics and Sterile Mfg

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

Leon Wyszkowski, President of Commercial Operations, Pharma Services, Thermo Fisher Scientific, provided updates of several key investments to expand the company’s global capacity and capabilities at the DCAT Member Company Announcement Forum held on March 21, 2022 at DCAT Week 2022. Key milestones in 2022 are focused in four main areas: (1) development and manufacturing for cell and gene therapies; (2) early-stage process development; (3) biologic drug-substance and sterile drug-product manufacturing; and (4) increased supply-chain digitalization.

Cell and Gene Therapies. In 2022, Thermo Fisher will open a 300,000-square-foot viral vector manufacturing site in Plainville, Massachusetts, which will expand the company’s capacity to six sites globally. Also in 2022, the company is expanding its cell therapy network with the addition of a 44,000-square-foot cell- therapy development and cGMP manufacturing center at the Mission Bay campus of the University of California, San Francisco (UCSF) as part of strategic partnership with UCSF.  

These investments follow the opening of a 67,000-square-foot cGMP plasmid manufacturing facility in Carlsbad, California, last year (2021) to support clinical and commercial needs for raw material and drug-substance development for cell and gene therapies and vaccines.

Early-Stage Process Development. Thermo Fisher has added capabilities for early-stage development, including translational sciences labs in San Diego, California, and Alachua, Florida. to support proof-of-concept studies to enable transition into preclinical studies and GMP manufacturing. 

In 2021, the company expanded its Quick to Clinic for Biologics, which enables rapid process development to accelerate molecules to clinic with reduced cycle times, and later this year (2022), the service will expand to viral vectors and small molecules. Also in 2022, the company is expanding its Quick to Care for Advanced Therapies (viral vectors, cell therapy, GMP plasmid and mRNA manufacturing), which integrates development and clinical services across the cell- and gene-therapy value chain. In addition, the new company launched new commercial packaging services for cell and gene therapies, which combines GMP storage, serialization, ultracold and cryogenic packaging, and global distribution at cryocenter sites in Frederick, Maryland, and Weil-am-Rhein, Germany.

Sterile Drug Product and Biologics Manufacturing. In the last two years, Thermo Fisher has added 13 sterile drug-product lines for liquid and lyo filling across its global sites and expanded product development services at its sites in Ferentino, Italy, and Greenville, North Carolina. In 2022, the company is expanding into Asia-Pacific with an integrated biologics drug-substance and sterile drug- product manufacturing facility in Hangzhou, China, and with a sterile manufacturing facility for large-scale commercial capacity and high-speed filling in Singapore.

On the biologics drug-substance side, Thermo Fisher is doubling biologics manufacturing capacity at its St. Louis, Missouri, site to support production growth from 2,000 L to 5,000 L. A new 58,000-square-foot expansion will be operational in 2023. Also, a new 1.5-million-square-foot biologics manufacturing facility for commercial-scale, large-volume manufacturing in Lengnau, Switzerland will be operational later this year (2022).  

Additionally, the company will launch mRNA synthesis capabilities at its site in Monza, Italy, to produce drug substance for vaccines and therapies.

Increased Supply Chain Digitalization. The company also highlighted its investments in digital technologies, including Pharma 4.0, launched last year (2021) at its site in Monza, Italy, and this year (2022) at its site in Greenville, North Carolina, and Ferentino, Italy, to integrate data and drive digital transformation within all phases of drug development and manufacturing. Its mySupply digital supply chain platform, launched for sterile drug products in 2021 and biologics this year (2022), provides visibility and collaboration with customers across the product lifecycle, including daily order management, batch tracking, and monthly forecasting.