Thermo Fisher Scientific and University of California, San Francisco to open cell therapy cGMP manufacturing and collaboration center

20 May 2021
Edward Carter
Publishing / Media

Thermo Fisher Scientific and the University of California, San Francisco (UCSF) have announced they have formed a strategic alliance to accelerate the development and manufacturing of cell-based therapies.

Under the agreement, Thermo Fisher will build and operate a 44,000-square-foot, state-of-the-art cell therapy development, manufacturing and collaboration center in leased space on UCSF's Mission Bay campus, which includes biomedical research facilities and hospitals. The site will offer clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support, to UCSF and other partners.

Expected to open in 2022, the facility will also serve as a central location where customers and UCSF researchers will have access to Thermo Fisher's broad portfolio of Cell Therapy Systems (CTS) reagents, consumables, and fit-for-purpose instrumentation and compliant software. The CTS product portfolio is designed to work together, and seamlessly transition from research to clinical manufacturing to address cell therapy production workflow challenges.

"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," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "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."

Sam Hawgood, MBBS, chancellor of UCSF, said, "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."

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StemPro™ Neural Stem Cells

Thermo Fisher Scientific

StemPro® Neural Stem Cells are cryopreserved human fetal brain-derived neural stem cells (NSCs). These cells are manufactured under Good Manufacturing Practice (GMP) manufacturing standards in a California-licensed facility and are available for Research Use Only. They are isolated and expanded in culture to passage 4 under a low oxygen (ischemic tolerant, proprietary manufacturing process using FBS-supplemented media and then cryopreserved in an animal origin-free cryopreservation medium. The cells are supplied at a concentration of 1 x 106 viable cells/vial. A Certificate of Analysis is available for each lot that documents the quality control specifications, test results, and donor information. These cells have no observed tumorigenicity/toxicity in GLP-compliant animal studies. StemPro® Neural Stem Cells help you to: • Minimize assay variability with itNSCs manufactured using GMP manufacturing standards • Improve functionality studies with immature, high potency NSCs • Complete experiments requiring one large lot of NSCs • Minimize your chance of assay failure by using tested cells, reagents, and protocols Immature, High Potency, Low Oxygen-Cultured NSCs StemPro® Neural Stem Cells are derived from human fetal brain from qualified, traceable donors. The cells are isolated, cultured, and expanded under Good Manufacturing Practice (GMP) manufacturing standards in a California-licensed facility using a proprietary Reduced Oxygen Tension manufacturing process. Manufacture of cells in a reduced oxygen tension environment results in higher yields of highly potent immature stem cells compared to cells expanded in normal oxygen culture conditions. Safety Tested StemPro® Neural Stem Cells have been demonstrated to be non-toxic and non-tumorigenic in GLP animal studies performed according to FDA guidelines. Large lots can be made available for those requiring assay standardization. Protocols using tested reagents are provided to help minimize your chance of assay failure using reagents and cells that have not been evaluated to work together. View our tested media and reagents. High Post-Cryopreservation Viability These StemPro® Neural Stem Cells are supplied in CryoStor® cryopreservation medium at a concentration of 1x106 viable cells/vial. CryoStor® medium is animal origin-free and shown to support high cell viabilities post-thawing. Controlled processes are used for cryopreservation, handling, and shipping to help minimize risk of adverse effects to the quality of the cells.

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Thermo Fisher Scientific and University of California, San Francisco to open cell therapy cGMP manufacturing and collaboration center