The Biologic Therapy Core Facility (BTCF) will facilitate 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. The core maintains a cGMP compliant and FDA registered 2,615 sq ft modern pharmaceutical cleanroom with 6 independent manufacturing suites and validated & calibrated production equipment. The highly trained staff, competent in regulatory compliance, directly partners with investigators to staff, operate, manipulate and/or manufacture early phase clinical materials in the core, including clinical grade cell and gene therapy products, DNA vaccines, reconstitution of peptides, and radio-labeled PET products.
The mission of the Biologic Therapy Core Facility (BTCF) is to assist Principal Investigators in 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. The Core envisions leading all Academic Based cGMP Manufacturing Facilities. The core fulfills its mission and achieves its vision by:
- Leveraging the considerable basic research scientific expertise of Principal Investigators at the Siteman Cancer (SCC), Barnes-Jewish Hospital (BJH) and Washington University School of Medicine (WUSM) by directly partnering with investigators to staff, operate, manipulate and/or manufacture early phase clinical materials in the core.
- Developing and manufacturing 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 regulations.
- Writing, implementing, and strictly adhering to phase appropriate cGMP procedures & regulations to provide for the highest level of product quality while also recognizing the dynamic nature of the early drug candidate developmental life cycle.
- Providing support for IND applications and approval by regulatory agencies in the fields of cellular & gene therapy, and other treatment modalities by assisting and helping Investigators with the administrative process of initiating a clinical trial.
- Developing and mentoring junior faculty and staff to conduct this type of research.
- Serving as a regional resource to foster academic-industry collaborations with SCC and WUSM investigators.
- Acting as the source of institutional expertise in cGMP research for investigators and committees across the institution.</li
- Routine tissue processing and cryopreservation (e.g. cryopreservation of parathyroid tissue).
- The manufacture of materials for use in clinical trials requires compliance with the FDAs cGMP regulations to ensure that these materials have their requisite quality attributes and identity, purity, strength, safety and potency that they are purported to have. Compliance is achieved by maintaining a state of the art cleanroom facility & equipment which provides a suitable environment in which aseptic manufacturing operations are performed; the organization and staffing of the facility with an independent QA unit which has the expertise and experience to oversee the Facilities Quality systems including Document Control, Deviation Reporting, Out of Specification investigation, and Change Control Procedures; a trained & competent manufacturing staff to perform manufacturing and maintenance of the facility and its equipment; documentation and control of all raw materials used in manufacture from initial receipt, through quarantine & release, and subsequent use; detailed and validated production processes with documentation of manufacturing via Batch Production Records or SOPs and worksheets; adequate control over packaging, labeling, and storage of products; and proper control over those laboratories that perform release testing of final products to include review of test results.
Service available to All entities, including for-profit organizations.
Priority service for Washington University and other non-profit organizations.
Priority is given to Siteman Cancer Center research members.
- Provides clean-room suites for cGMP manufacturing of cell products, radio-labeling of infusates for PET imaging studies, DNA vaccine production, cell selection, viral vector production, peptide manufacture, and numerous other clinical applications
- Production of Recombinant Protein;Cryopreservation and storage of parathyroid tissue post surgery
- Thawing of parathyroid tissue for autologous implantation
- cGMP vialing of biologics and non-biologics for clinical use
- cGMP production of plasmids for vaccine manufacture and other applications
- Cell selection and depletions of blood products for transplantation and other applications using Miltenyi’s CliniMACS®: CD34 selection, CD3/CD19 depletions, CD133 selection, CD56 selection, TCRab depletions; and various other selections and depletions
- cGMP monitored critical storage at all temperature ranges (2-8°C, less than -20°C, less than -70°C, Liquid Nitrogen, ambient)
- Bacterial Endotoxin testing using the Charles River PTS system
- Assistance with preparation and submission of Investigational New Drug (IND) applications and Regulatory filings
- CliniMACS® Cell Sorter (Miltenyi Biotec) allowing for selections or depletions of specific cell markers in pheresed blood products
- The system allows for adaptability in selected cell populations
- Monitoring system allows for 24/7 control of all critical systems
- The system monitors and alerts the staff to any out of specifications for differential pressures, room temperatures, and critical storage
- All critical storage (-80°C, -20°C, 4°C, Liquid Nitrogen, and CO2 incubators) are cGMP compliant and monitored
- Johnson Controls alerts staff to any alarms
- Critical storage is certified yearly as working within specifications
- A Steris Autoclave with cGMP compliance and validation is suitable to meet sterilization needs for manufacturing
Please contact this core directly for pricing information.
Siteman Cancer Center (SCC)