Applied Gene and Cell Therapy Center's cutting-edge facilityboosts capacity tomanufactureinnovative therapies for clinical trials
Cincinnati Children'stoday celebratedthe opening ofanew state-of-art facility for itsApplied Gene and Cell Therapy Center, which will enable the health system to increase clinical trials of innovative drugs andbiological therapeuticsfor patients with cancer, blooddiseasesandgenetic disorders.
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“OurApplied Gene and Cell Therapy Centeristhelaunchpad for new cures,” saidTina Cheng, MD,director of theCincinnati Children's Research Foundation,chief medical officerandchair of Pediatrics.”This center takespromising science, makesit real, and helpsbring hope to patients and families who need it most.”
Cincinnati Children's, which ranks No. 1 in the nation for pediatric cancer care, acquired and renovated a largebuilding in Sharonville, Ohio,toexpandthe Applied Gene and Cell Therapy Center.It'sfour times bigger andhasfar greater capacityto manufacture gene,celland immunotherapytherapy productsthan thefacilityin Cincinnati's Avondale neighborhood where the center has been basedsince 2001.
The ribbon-cutting ceremonyon Nov. 17, 2025, includedCincinnati Children'sscientists, engineers and clinicians who collaborateto design andmanufacturegene and cell therapy products-often custom-made to correct or replacea patient'sfaulty genes or to empowertheirimmune cells to fight refractory diseases that don't respond to standard treatments.
Over300,000 childrenthroughout the world are diagnosed with cancer every year, and an estimated 8 million are born with a birth defect.Thousandsof Cincinnati Children's19,600 employeesare engaged in research to find medical treatments or curesfor such ailments, and every year families from all 50 states and dozens of countries travel to Cincinnati Children's to receive care for complex or rare disorders.
“Children and families grappling with cancer or genetic disorders often look to Cincinnati Children's for innovative treatments, andthe work that will be conducted atthenew home for our Applied Gene and Cell Therapy Center willimprove outcomesforeven morekidswith the hardest-to-treat illnesses,” said Stella Davies, MBBS, PhD, co-executive director of the health system's Cancer and Blood Diseases Institute as well as director of the Division of Bone Marrow Transplantation and Immune Deficiency.
In addition to advancing the work of Cincinnati Children's researchers, the new home of the Applied Gene and Cell Therapy Center was designed to accelerate therapies by enhancing collaboration with partners such as large pharmaceutical companies, biotech firms, universities and other health systems.
“What makes the Applied Gene and Cell Therapy Center unique is that it's not just a research lab and it's not just a manufacturing facility – it's both,” said Chaozhong”Charles” Zou, executive director. “The center is tightly connected to the clinical side of Cincinnati Children's, which means discoveries can move faster from bench to bedside, enabling patients to gain access to new therapies sooner.”
The Cincinnati Children'sAppliedGeneand CellTherapy Center developsvectors andcellular productsfor diseases suchastelomere biology disorders, whichresult from gene mutations thatcan lead to premature aging,organproblemsand a predisposition to cancers such as leukemia.Other therapies focus oncombatting blood disorders such as sickle cell disease, which can cause severe pain and organ damage. Additional research focuses on developing treatments for hereditary protein alveolar proteinosis, a lung diseasethatcancauseshortness of breath,achroniccoughand fatigue.
Gene and cell therapy products are living,highly complexmedicines, Zou noted.The production process must meet exacting regulatory standards to ensure that every patient in a clinical trial receives the same therapy, made to the highest possible level of consistency and safety.
To achieve that, thenew home of theAppliedGene and Cell Therapy Centerwasbuilt with extraordinary attention to detail. The air is filtered to beevencleaner thanthat of ahospital operating room. The temperature and humidity remain tightly controlled at each individual room level.Every element, including specialized airfilters,was designed to prevent even the smallest contamination or variation.
Now, the buildingat 10995 Canal Roadwillnowundergo a certification process, expected to take one year,to ensurethe centermeetsrequirementsfor the manufacture of gene,celland immunotherapy products for clinical trials.The onsite manufactureofsuchtherapiesshouldbeginby early 2027.
Up to100 Cincinnati Children's employees will work at thelargerApplied Gene and Cell Therapy Center, including 24 recruited to fill new positions.About half of the new hiresarescientists – including biologists and those focused on quality assurance of medicinal products, which is known as Current Good Manufacturing Practice, or cGMP.
The newfacilitybuilds on the success of thecenter (previously namedthe Cincinnati Children'sTranslational Core Laboratory), which has been a leader in the development, testing and manufacturing of such drugs and therapeutics for early phase clinical trials fornearly 25years.
“What differentiates thisnewcenter is a combination of scale, capabilities and the way we operate,” Zou said. “Thisfacility is over50,000 square feetand houses 12state-of-the-artclean roomsdesigned to prevent contaminationduring the production of gene and cell therapies, making it one of the largest academic centersof its kindin the world. But beyond size, what truly sets us apart is that weoperateat industry standards, with rigorous processes and quality systems in place, ensuring that the products we develop meet the same expectations as those from leading biopharma companies.”
Cincinnati Children's invested $60 millionto buildthenew home of theApplied Gene and Cell Therapy Center, including design,constructionand equipment.The building, previously an auto parts distribution facility, encompasses111,000 square feeton a 14.6-acre site.About50,000 square feetof the buildinghousesthe Applied Gene and Cell Therapy Center.The rest servesas a supply chain distribution hub for Cincinnati Children's three hospitals and over 40 other locations.More than two dozen additional people will work at the distribution hub.
Danis Construction Building Co.wasdesign-builder for the project. The design team included: BHDP Architecture; Heapy Engineering for mechanical, engineering and plumbing; Schaefer for structural engineering; andbioX for process engineering.
About Cincinnati Children'sCincinnati Children's is ranked among the best pediatric health systems in the nation byU.S. News & World Report, includingNo. 1in three specialties: Cancer care, Gastroenterology & GI surgery, and Diabetes & Endocrinology. As the leader in improving child health, Cincinnati Children's cares for patients from all 50 states and dozens of countries, including kids with complex or rare disorders. Established in 1883, the academic health systemleads the way in healthcare education and pediatric research, where discoveries become innovative treatments and cures that change the outcome for children. All of this is backed by an extraordinary culture that includesnearly 20,000team members;Cincinnati Children's ranks No.1 in Ohio and No.5 in the nation on theForbeslist ofAmerica's Best Employers for Healthcare Professionals.More information:CincinnatiChildrens.org
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