Located on the 6th floor of Emory University Hospital (EUH), within the Emory Healthcare Blood Bank, construction of the EPIC Cell Processing Core compliant with FDA cGMP Phase I good manufacturing practices has been completed. This Cell Processing Facility will foster development of novel personalized cellular therapies for Emory patients facing catastrophic ailments and unmet medical needs.
To render accessible a cutting edge facility and investigational materials to foster innovative the development of cellular pharmaceuticals and biotherapies for treatment of human catastrophic illnesses.
An Emerging Biopharmaceutical. Blood and marrow derived cells have been used for more than a quarter century to treat life threatening hematological conditions and are now established therapies worldwide. More recently, the use of specific adult somatic cells from marrow, blood and other tissues are being studied in cellular medicine of a wide array of ailments including heart, lung, neurological and immune diseases. The use of blood borne immune cells can also be exploited for treatment of cancer, autoimmune disease, organ transplantation and chronic viral illnesses such as HIV. The common denominator for these applications is the requirement of programmatic supported enabling Core like the EPIC facility where like-minded scholars and translational scientists can interact in a proactive and goal-driven manner.
The Core facility was designed and built as class 10,000 clean room. Humidity temperature, air quality and pressure are tightly controlled to maintain a GMP (Good Manufacturing Practice) environment as mandated by the FDA for the generation of cellular products. The room possesses two biological safety hoods, 4 CO2 incubators, upright and inverted microscopes, Invitrogen Countess automated cell counter, Cobe 2991 Cell Processor and the ClinMACs cell selection device. In the future the facility will render accessible CLIA (Clinical Laboratory Improvement Act) compliant flow cytometry, Sysmex particle analyzer, protein and gene analysis equipment.
The highly qualified (HQ) personnel employed who operate EPIC will act as resources to assist clinicians and researchers in developing robust translational data to support the clinical development of their products. These HQ persons will provide scientific input on trial design, regulatory oversight and assist in product development issues related to scale up, release criteria, potency and sterility testing. In addition these persons will be available for consultation in the strategic planning and writing of protocols for submission to the IRB and FDA.
The Core Facilities at Emory are here to support your research. In order to ensure that the appropriate recognition is attributed to the facilities, please acknowledge the facilities on all publications.