CETI's GMP for Immunotherapy Laboratory
As part of the Cell Enhancement and Technologies for Immunotherapy (CETI) Program, Children’s National has one of the only stand-alone pediatric cell therapy GMP facilities to receive more-than-minimal manipulation accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT). We have a specialized research team dedicated exclusively to cellular therapy, working in an advanced, sophisticated Current Good Manufacturing Practice (cGMP) facility that adheres to regulations established by the U.S. Food and Drug Administration (FDA). We use the most up-to-date technology, systems and equipment to manufacture the highest quality product, as per the FDA’s stringent standards. These cells are used to treat patients from across the country who travel to Children’s National to receive this personalized therapy.
The GMP 3.5 facility contains two processing rooms with three ISO 5 A2 biological safety cabinets, three double stacks of temperature-controlled carbon dioxide incubators, two Quantum Cell Expansion Systems, one Elutra Cell Separation System, a -80 degrees Celsius freezer and 4 degrees Celsius refrigerator, and three tabletop centrifuges for cell isolation.
The GMP 5 facility contains two processing rooms with two ISO 5 A2 biological safety cabinets, two double stacks of temperature-controlled carbon dioxide incubators, two VIA Freeze Controlled-Rate Freezers, one -80 degrees Celsius freezer and two undercounter 4 degrees Celsius refrigerators, and two tabletop centrifuges for cell isolation.
- Virus-specific T cells
- Tumor-specific T cells
- Dendritic cells
- Lymphoblastoid cell lines
- Mesenchymal stromal cells (MSCs)
- Nan Zhang, Ph.D., Assistant Director, Manufacturing
- Jay Tanna, M.S., RAC, Cell Therapy Lab Quality Assurance Manager
- Chase McCann, M.S.P.H., Ph.D., Cell Therapy Lab Lead
- Arber Decja, B.e.C., Business Analyst
- Tyra Durrett, B.S., Program Assistant
- Abeer Shibli, M.T., Cell Therapy Lab Specialist
- Sam O’Brien, B.S., Cell Therapy Lab Associate II
- Sianna Burnett, B.S., Cell Therapy Lab Associate II
- Maryam Pasdar, B.S., Cell Therapy Lab Associate II
- Madhuwanti Srinivasan, M.S., Cell Therapy Lab Specialist
- Adriana Pitino, M.S., Cell Therapy Lab Quality Assurance Coordinator