A new laboratory designed to advance early-stage research into lifesaving, commercially viable therapies was celebrated on the USC Health Sciences Campus Tuesday night.
Housed at the USC Norris Comprehensive Cancer Center, the USC/CHLA cGMP Laboratory will manufacture cell and gene therapies under the Food and Drug Administration’s good manufacturing practice (cGMP) standards.
Therapies developed in the lab could one day be used to treat diseases such as arthritis, blindness, cancer and diabetes.
The 3,184-square-foot facility offers cleanrooms, laboratory space, cryostorage and state-of-the-art equipment for manufacturing and analytical testing. It was launched through a partnership between Children’s Hospital Los Angeles, Keck Medicine of USC and the Keck School of Medicine of USC.
The lab’s collaborative structure, broad expertise, specialized resources and regulatory knowledge will help accelerate big ideas and positive “disruption” to health care, said USC President Carol L. Folt, PhD.
“Effective partnerships can facilitate these breakthroughs while also supporting the steady, incremental and absolutely critical advancements” necessary to move an idea from lab to bedside, Folt said. “Billions of lives across the world could be changed by this work.”
Keck School of Medicine Dean Carolyn Meltzer, MD, who began her position in March 2022, praised the countless hours teams spent bringing the idea to life.
“I came here because this institution really embodies interdisciplinary collaboration to solve the tough problems,” Meltzer said. “And this is a moment where we’re well positioned for disruptive growth and impact, which is really what’s most meaningful.”
The partnership demonstrates continued “representation of what world-class organizations can do working together,” said Paul Viviano, president and chief executive officer of CHLA, noting that his institution and USC have maintained an affiliation since 1932. “This magnificent center is a major step forward.”
The lab is part of a larger effort — the USC/CHLA Cell Therapy Program — to advance the science and translation of cell therapies at both institutions. (The program is tied to the USC+CHLA Alpha Clinic, which in November 2022 was awarded a five-year, $8 million grant from the California Institute for Regenerative Medicine.)
This effort marks continued momentum for expanding precision medicine. The cGMP lab’s multidisciplinary teams will work to further leverage the power of modified cells — as seen in CAR T-cell therapy, which reengineers patients’ immune cells to fight their own blood cancers — and apply them in new ways.
“The great thing about cell therapy is that patients are not passive receiving treatment; they are active participants,” said Mohamed Abou-el-Enein, MD, PhD, MSPH, executive director of the USC/CHLA Cell Therapy Program and director of the new cGMP lab.
The facility, he added, is “the missing puzzle piece that can enable us to bring homegrown discoveries to the clinic and to our patients.”
Abou-el-Enein expects the lab to serve 200 patients annually and partner with leading biotech companies. He also intends for it to help train a new generation of scientists and to prioritize pediatric and East Los Angeles patient populations.
Housing multiple parts of the development process under one roof offers a distinct advantage for researchers and patients, said Rod Hanners, chief executive officer of Keck Medicine.
“Cell-based therapies represent a quantum change in medical treatments,” Hanners said. “The establishment of the Translational Cell Therapy program between Keck Medicine of USC, Keck School of Medicine of USC and Children’s Hospital of Los Angeles, including the new cGMP facility, provides the collaboration, expertise and infrastructure to take new therapies and move them into clinical trials — all with the promise of curing diseases that affect our patient population.”
— Kevin Joy