The Emory Personalized Immunotherapy Core is located within the premises of Emory University Hospital Blood Bank. The core is a 300 ft2 clinical-grade, fully equipped, high sterility isolation facility. It is designed as an enabling infrastructure to support early phase clinical trials of cell-based therapies where processing of human cell and tissue is required as part of a FDA-sponsored biopharmaceutical study. It is accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) for more than minimally manipulated cellular therapy products. The facility is manned by a team of highly qualified personnel dedicated to the successful implementation and prosecution of cellular therapy clinical trials. The purpose of this designated Core facility is to directly support investigator-driven phase I/II cell therapy clinical trials at Emory. As a Core facility, EPIC provides a unique resource to the Emory community in assisting the translation of cellular therapies from the bench side to the clinic. The facility possesses the necessary infrastructure to manufacture cellular therapies under FDA approved good manufacturing practices (FDA cGMP Phase I guidance July 2008). This facility was designed to be nimble and adaptable and can support the manufacturing needs of most small enabling cell therapy clinical trials.
The Emory Personalized Immunotherapy Core (EPIC) is subsidized by the Emory University School of Medicine and is one of the Emory Integrated Core Facilities. Additional support is provided by the National Center for Georgia Clinical & Translational Science Alliance of the National Institutes of Health under Award Number UL1TR002378.