AURORA | Researchers at the University of Colorado Anschutz Medical Campus cut the ribbon on a new on-campus facility April 6 that is expected to thrust Aurora’s health Mecca to the national forefront of adult stem cell and protein-based biologic research.
Housed in a 14,000-square-foot laboratory, the Gates Biomanufacturing Facility will focus on providing regenerative therapies for patients with diseases ranging from macular degeneration and skin irregularities to cancer. The biomanufacturing facility joins only five others like it in the U.S. and will be the only such site within a 500-mile radius, according to Patrick Gaines, executive director of the Gates Center for Regenerative Medicine — a separate on-campus entity that spearheaded the effort to establish the new site on East Montview Boulevard.
“This is not only for CU Anschutz, but for Colorado and beyond,” Gaines said in a statement. “This facility now allows us to take ideas and fully develop them through to patient delivery.”
The Gates Center for Regenerative Medicine is a 74-member consortium of individuals from CU Anschutz, National Jewish Health, CU Boulder, Colorado State University, Colorado School of Mines and businesses. The Gates Center has secured financing for the new $17-million biomanufacturing facility through 2018.
Taking a concept from the drawing board to a patient’s bedside is a vital system at CU Anschutz, but one that has been effectively incomplete without a legitimate manufacturing space, according to Dennis Roop, future director of the Gates Biomanufacturing Facility. Roop explained that without a proper ‘Good Manufacturing Practice” site — the designation granted by the Food and Drug Administration for a manufacturing site that meets their rigid professional standards — clinical projects have the potential to be taken out of state, and with them, some of the medical campus’ top talent. That’s a trend that delays getting new treatments to patients who need them at Children’s Hospital Colorado and University Hospital, even though CU Anschutz researchers are creating effective remedies in labs just a couple hundreds away.
“Some of our young faculty who literally have developed new techniques for cell expansion — that no one else in the world has been able to do — would be lost to other institutions, because they’re driven to get (those technologies) into the clinic,” Roop said. “If we hadn’t had the promise of this facility, some of the new recruits that we’ve invested in, we would have lost.”
Before opening the new facility, Children’s Hospital was the only top 10 hospital in the country without access to a Good Manufacturing Practice site, according to Roop.
Now, a drug or restorative therapy can go through the first few stages of clinical trials at the clean manufacturing facility and have its first patient trials at one of the nearby on-campus hospitals.
“Many of the products that will be developed in the (biomanufacturing) facility will actually then be used in clinical trials at both Children’s Hospital as well as University Hospital and in many cases these will be the first time they’ve ever been used for patients,” Roop said.
In addition to manipulating proteins like insulin, Roop explained that much of the biomanufacturing facility’s work will be based in stem cells. However, the facility dodges the ethical quagmire attached to embryonic stem cells by only using cells taken from adults.
“These are adult stem cells that we reprogram back to an embryonic state, but are not taken from an embryo,” Roop said. “So, we don’t have the stigma of having to destroy early fertilize embryos — they’re just taken from a biopsy of adult’s skin.”
A procedure first discovered by Japanese Nobel Prize Laureate Shinya Yamanaka in 2006, Roop said that these adult cells also have a decreased likelihood of being rejected by their eventual recipient.
Although the new biomanufacturing facility is not intended to turn a profit, Gaines said the site boasts a strong potential ability to attract the business of private pharmaceutical companies as well as nearby biotech startups.
“There are private industry, large and small pharmaceutical companies that push out this kind of research and development, so they are actually looking for universities that will do this for them,” Gaines said. “And if those products are developed here, they’re probably going to stay here.”
Gaines said that if the manufacturing facility does experience robust success, there is ample room to expand thanks to dozens of acres of developable land to the east, courtesy of the Fitzsimons Redevelopment Authority.
The roughly dozen-person team that will operate the Gates biomanufacturing operation is slated to begin training later this month and is expected to begin clean-lab research sometime this fall.