Advancing regenerative medicine therapies

Discoveries in the new Good Manufacturing Practice facility will expand novel gene and cell treatment options for patients

“The establishment of the UC Irvine GMP facility marks an exciting new era in medical innovation and patient care. We are poised to pioneer advances in translating regenerative therapies from the laboratory into clinical practice, expanding treatment options for those struggling with complex diseases,” says Dr. Michael J. Stamos, dean of the UC Irvine School of Medicine. Credit: Steve Zylius / UC Irvine

Orange, Calif. — University and community guests recently gathered to celebrate the grand opening of the 7,700-square-foot Good Manufacturing Practice facility in Hewitt Hall’s basement at UC Irvine. Although the highly sterile environment remains off-limits for tours, the gala highlighted its importance to the campus, the UC system and the local community.

“This facility is not just a building; it is a powerhouse of innovation and hope, meticulously designed and equipped to produce FDA-compliant cell and gene therapies, which are at the forefront of medical science’s promise for the future,” says Dr. Michael J. Stamos, dean of the UC Irvine School of Medicine.

“It symbolizes our commitment to developing advanced treatments for neurological diseases and cancers that position us at the forefront of translational research, clinical trials and patient services, that were once deemed unattainable.”

The facility is primarily dedicated to producing cell and gene products that meet stringent GMP regulations enforced by the FDA. In addition, researchers and scientists will use next-generation automated processing and manufacturing technologies, supplemented by leading-edge analytical tools, to produce the transformative therapies essential for clinical trials.

A collaborative effort

The School of Medicine, the Susan & Henry Samueli College of Health Sciences, the Sue & Bill Gross Stem Cell Research Center and the Chao Family Comprehensive Cancer Center and other campus partners have dedicated more than $12 million to the facility.

“Our commitment to taking a multidisciplinary approach to integrating groundbreaking research with clinical applications was also recognized and supported by the California Institute for Regenerative Medicine,” says Aileen Anderson, PD, director of the UC Irvine Stem Cell Research Center and professor of physical medicine & rehabilitation.

“We were awarded an initial two-year, $2 million grant to help launch this project, along with membership in the prestigious CIRM Cell and Gene Therapy Manufacturing Network.”

Next-generation treatments

The GMP facility has a seven-room cellular therapy and viral vector production area, an adjacent quality control laboratory, and a storage warehouse for raw and finished products. It is designed to create FDA-approved stem cell, engineered chimeric antigen receptor T-cell and gene products for clinical research and treatment across multiple medical disciplines.

These potentially pioneering therapies require meticulous production and processing to meet the complex needs of current clinical trials, enhance delivery and improve patient outcomes. They target a range of conditions, including neurological diseases, spinal cord injuries, autoimmune diseases like multiple sclerosis and lupus, and cancers such as leukemia and lymphoma.

Workforce development

In addition to advancing treatment options, the facility will provide educational opportunities and hands-on experience in GMP processes to prepare the next generation of scientists and clinicians who will lead the development of innovations in regenerative medicine.

“By fostering interdisciplinary collaboration, investing in state-of-the-art technology and focusing on comprehensive training, our new facility demonstrates the university’s commitment to translational research and clinical excellence that will offer new treatment options for patients worldwide who will benefit from these groundbreaking discoveries,” Stamos says.