The mission of the Biologic Therapy Core Facility (BTCF) is to support the rapid and early translation of promising novel research into clinically relevant interventions intended to treat, prevent, or improve outcomes for cancer and other diseases.
Highly trained staff, competent in regulatory compliance, directly partner with investigators to operate, manipulate and/or manufacture early phase clinical materials in the core. Services performed include generation of complex clinical grade cell and gene therapy products, personalized DNA vaccines, and related biologics. The BTCF also supports CGCI investigator-initiated trials utilizing NK cell and CAR T-cell therapy.
The 2,615 square-foot BTCF is located in the Southwest Tower on the campus of Washington University School of Medicine. Since its inception, the facility has helped to develop and manufacture novel biologic, cellular and other state-of-the-art therapeutics for human administration under controlled conditions in accordance with the U.S. Food and Drug Administration and other regulatory guidelines. This has been accomplished by acting as the source of institutional expertise in Current Good Manufacturing Practices (cGMP) for investigators and by strictly adhering to phase appropriate cGMP procedures & regulations to provide the highest level of product quality. Accordingly, the BTCF leverages — and partners with — the considerable scientific expertise of Principal Investigators at the Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine.
The organization and staffing of the facility relies on an independent QA unit, which has the expertise and experience to oversee the BTCF’s quality systems, including Document Control, Deviation Reporting, Out of Specification Investigation, and Change Control Procedures. Manufacturing technicians produce therapeutics, maintain the facility and its equipment, and ensure proper documentation and control of raw materials used in manufacturing.
Working alongside investigators and across institutional partner lines, BTCF staff establish detailed and validated production processes and release testing to ensure proper and consistent manufacturing is achieved in accordance with cGMP guidelines as outlined by the Code of Federal Regulations.
BTCF is an FDA-registered, restricted access facility with a modern pharmaceutical cleanroom environment in which aseptic manufacturing operations are performed within six ISO Class 7 manufacturing suites or a closed cellular therapy suite. Within each manufacturing suite, the BTCF supports ISO Class 5 biosafety cabinets that are integrated with ISO Class 8 support areas. The facility possesses intrinsic engineering controls to maintain and monitor proper differential pressure gradients between adjacent areas as well as to control personnel and raw material traffic flow throughout the facility.
Robust cleaning and environmental monitoring programs are in place to ensure the BTCF remains appropriate for aseptic manufacturing efforts. The BTCF provides traditional laboratory equipment (Centrifuges, Biosafety Cabinets, CO2 Incubators) as well as specialized equipment to support cell selection and depletion of blood products for transplantation and other cellular therapy applications using Miltenyi’s CliniMACS® and CliniMACS Prodigy® platforms. The facility provides continuously monitored critical storage at all temperature ranges (Ambient, 2-8°C, 37°C, < -20°C, < -70°C, Liquid Nitrogen) and has an on-call staffing program to ensure timely response to all emergent situations during or after normal business hours.
BTCF Medical and Scientific Director
Todd Fehniger, MD, PhD
Laboratory Supervisor/Quality Assurance Manager