UCI named one of CIRM’s cell and gene therapy manufacturing facilities

$2 million state grant allows campus stem cell center to advance regenerative medicine

“This network will be a game-changer for cell and gene therapy manufacturing by working to accelerate regenerative medicine clinical trials that originate from both academic faculty and companies seeking to bring new treatments to market,” said Aileen Anderson, director of UCI’s Sue & Bill Gross Stem Cell Research Center and principal investigator for the CIRM grant.

Irvine, Calif.  — With a two-year, $2 million grant from the California Institute for Regenerative Medicine, the University of California, Irvine has earned membership in CIRM’s Cell and Gene Therapy Manufacturing Network.

The goals of the statewide group are to accelerate pathways to commercialization for cell and gene therapies; advance industry standards; incorporate quality by design in cell and gene therapy manufacturing; and build a diverse, highly skilled manufacturing workforce in California.

“This network will be a game-changer for cell and gene therapy manufacturing by working to accelerate regenerative medicine clinical trials that originate from both academic faculty and companies seeking to bring new treatments to market,” said Aileen Anderson, PhD, director of the UCI Sue & Bill Gross Stem Cell Research Center and principal investigator for the CIRM grant.

“Our unique focus on the manufacture of cell and gene therapies for clinical trials in neurological diseases and cancer will increase access for our patients and empower us to lead the way in bringing novel regenerative treatments into clinical practice.”

Other member sites are:

• Cedars-Sinai Medical Center
• City of Hope
• Stanford University
• UCLA
• UC Davis
• UC San Diego
• UC San Francisco
• USC

'Good manufacturing practices' facility

The new CIRM funding will supplement the $12 million that the UCI School of Medicine and campus partners have invested so far toward the construction, build out and activation of a “good manufacturing practices” facility in Hewitt Hall to produce FDA-compliant cell and gene therapies. It will support the development and maintenance of a maximally efficient operations structure — including an electronic records system — and allow increased staff training in industry quality standards and compliance.

The grant’s second major focus will be workforce development. Consistent with UCI’s strong track record of valuing diversity, equity and inclusion, efforts will be made to integrate GMP programmatic goals with opportunities to enhance the delivery of cell and gene therapies to medically underserved populations and create a diverse workforce.

In addition, the CIRM funding will be used to develop and implement programs to provide a pipeline of qualified personnel to fill GMP positions both locally and across California. These efforts will leverage existing CIRM educational initiatives at UCI, including the CIRM Scholar, COMPASS and Bridges programs.

Increasing access to groundbreaking treatments

This project will have a significant public impact by increasing Californians’ access to cutting-edge medical treatments and by driving economic growth through fostering top talent and innovation in the state’s biotechnology industry.

“The GMP facility will serve as a conduit to translate discovery into clinical research,” said Roberta Marino, UCI’s GMP facility manager.

“Over the last three years, the UCI campus, in partnership with the Sue & Bill Gross Stem Cell Research Center, has made extensive infrastructure investments, including two new research clinics, the GMP production facility and a cell processing laboratory. Together, our efforts will provide added value to CIRM’s Cell and Gene Therapy Manufacturing Network and the regenerative medicine ecosystem in California and beyond.”

About the UCI Brilliant Future campaign: Publicly launched on Oct. 4, 2019, the Brilliant Future campaign aims to raise awareness and support for UCI. By engaging 75,000 alumni and garnering $2 billion in philanthropic investment, UCI seeks to reach new heights of excellence in student success, health and wellness, research and more. The Sue and Bill Gross Stem Cell Research Center plays a vital role in the success of the campaign. Learn more. 

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About the University of California, Irvine

About the University of California, Irvine: Founded in 1965, UCI is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide. For more on UCI, visit www.uci.edu.