The Center for Human Therapeutics is a new, FDA-approved facility for the production of cellular and immune clinical products for human clinical trials at the University of Virginia. Located on the second floor of Pinn Hall, the 7500 square foot facility includes a Good Manufacturing Practice (cGMP), multi-use, clean room complex.
Construction began in 2016 when Dr. Richard Shannon, executive vice president of health affairs; Dr. David Wilkes, dean of the School of Medicine; and Dr. Tom Loughran, Jr., director of the UVA Cancer Center, recruited Dr. Lawrence Lum, scientific director of bone marrow transplantation and director of cellular therapy, to lead the Emily Couric Cancer Center’s program development for T cell adoptive immunotherapy. Part of Dr. Lum’s startup support package included $9.3 million in funding—allocated by the Commonwealth in support of clinical research at UVA—to build a new cGMP clean room facility.
The facility includes six ISO 7 manufacturing clean rooms that have been custom designed for the manufacture and processing of different types of clinical products for investigator initiated trials, including: immune cell products, bispecific antibody targeted T cells, chimeric antigen receptor T cells, vaccines, bispecific antibodies, and monoclonal antibodies. The facility will also support the preparation of islet cells for transplantation and, in the future, the production of solution phase nanoparticles for human clinical use.
Connected by an ISO 8 hallway, the six clean rooms experience approximately 30 air exchanges per hour. Support facilities include a quarantine supply room, locker facilities, a quality control/quality assurance room, and offices for the leadership and staff. The facility is outfitted with alarm systems for monitoring air pressure differentials, room temperature, freezer and refrigerator temperatures, CO2 and O2 levels in the liquid nitrogen freezer rooms, and sensor interface for bioreactors.
Thanks to the construction teams at UVA and those who partnered with the University to undertake this feat, construction is complete and validation of the facility is being finalized. The only complex of its kind in Virginia, the Center for Human Therapeutics will be operational in April 2019.
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