As part of the Program for Cell Enhancement and Technologies for Immunotherapy (CETI), 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 cGMP facility. cGMP refers to the Current Good Manufacturing Practice 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 ISO7 facility contains one ISO-5 A2 biological safety cabinet, a double stack of temperature controlled CO2 incubators, a 4°C refrigerator and table top centrifuge for cell isolation. The ISO8 facility contains of one 4-foot A2 ISO5 biological safety cabinets, one 6-foot A2 ISO5 biological safety cabinet, a double stack of temperature controlled CO2 incubators, two table top centrifuges, dedicated space for supply storage in addition to a sink, water baths, -80°C freezer and standing refrigerator.
The facilities also include the following specialized equipment and instruments:
- Quantum Cell Expansion System (2)
- Nexcelom Counting Device
The GMP space is ideally suited for production of GMP or “351” products that are more than minimally manipulated and held under Investigational New Drug status with the FDA. These are products only available at Children’s National and are manufactured for our clinical trials.
Examples of cells manufactured in this environment include:
- Virus-specific T cells
- Tumor-specific T cells
- Dendritic cells
- Lymphoblastoid cell lines
- Mesenchymal stromal cells (MSCs)
- Nan Zhang, Ph.D., Manufacturing Team Lead
- Jay Tanna, M.S., RAC, Quality Team Lead
- Robert Ulrey, M.S., Process Development Team Lead
- Abeer Shibli, MT (ASCP)
- Morgan Galligan, B.S.
- Uduak Ekanem, M.S.
- Stephanie Val, Ph.D.
- Madhuwanti Srinivasan, M.S.
- Adriana Pitino, M.S.