Thermo Fisher, UCSF Boost Manufacturing of Cell-Based Therapies

Thermo Fisher Scientific and the University of California (UCSF) recently formed a strategic alliance to accelerate the development and manufacturing of cell-based therapies.

Under the terms of agreement, Thermo Fisher Scientific will build and operate a 44,000-square-foot cell therapy development, manufacturing, and collaboration center on UCSF’s Mission Bay campus. 

The center will include biomedical facilities and hospitals, as well as clinical and commercial cGMP cell therapy manufacturing services and associated technology development support to UCSF and other partners, a Thermo Fisher Scientific spokesperson explained. 

"We are bringing together UCSF's leadership in the newest forms of cellular immunotherapy and Thermo Fisher's extensive capabilities in cell therapy instrumentation, manufacturing and distribution," Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific, said in the announcement. 

"This powerful combination will provide customers – from emerging biotechs to large pharma companies – with integrated, end-to-end solutions to reduce costs and accelerate adoption of cell therapies, ultimately improving patient access to these transformative treatments,” Stevenson continued.

The facility will also serve as a central location where customers and UCSF researchers can access Thermo Fisher Scientific’s broad portfolio of Cell Therapy Systems (CTS) reagents, consumables, and fit-for-purpose instrumentation and compliant software. 

CTS products provide a choice for clinical stem cell therapy and immunotherapy research and manufacturing. This allows for the transition of a cell therapy to the clinic with confidence.

Additionally, Thermo Fisher Scientific stated that its GMP-grade and CTS products have cell and gene therapy specific intended use statements, extensive safety testing, and proactive regulatory documentation to help minimize risk, ease the burden on quality systems, and support regulatory submission. 

"We expect breakthrough treatments for many different diseases and conditions to come from cell therapies. Establishing cell therapy manufacturing in such close proximity to our scientists, clinicians and patients will enable UCSF to catalyze innovation in living therapeutics and use the resulting discoveries to benefit our patients,” said Sam Hawgood, MBBS, chancellor of UCSF. 

Cell and gene therapy introduces stem cell populations into patients with chronic diseases to replace diseased cells with healthy ones. 

Although current cell therapy mainly focuses on cancer, the therapies have proven to be effective in treating other chronic diseases, such as Parkinson’s Disease, type 1 diabetes, and heart disease. 

Throughout recent years, Thermo Fisher Scientific has significantly expanded its therapies footprint, becoming one of the leading companies in the gene and cell therapy sector. 

In May 2020, the company launched a $180 million commercial manufacturing site to more than double its commercial viral vector capacity to support increasing demand for the development and manufacturing of cell therapies and vaccines.

The project will add over 200 jobs and complement Thermo Fisher Scientific’s recently expanded capacity in Massachusetts and Florida.

Specifically, the new Massachusetts-based manufacturing site is slated to leverage digital connectivity and capabilities to enable operational efficiencies, high quality, data visibility, and advanced operator training, Thermo Fisher Scientific said in the May announcement. 

The project is expected to be completed in 2022

Then in December, Thermo Fisher Scientific announced the construction of a new cGMP plasmid DNA manufacturing facility in California to expand its efforts in gene and cell therapy. 

The facility will expand the company’s clinical and commercial capabilities for cGMP plasmid and DNA, which are used as a critical raw material. Additionally, the site will help to produce large-scale plasmid DNA as a primary drug substance for DNA therapies.

Thermo Fisher Scientific stated that the facility will build on the company’s investment in cell and gene therapy services, as well as ensure customers can leverage development and manufacturing capabilities.

In total, the facility will add nearly 150 jobs over the next 12 months.