The second lab is our GMP (good manufacturing practices) lab. Here, we manufacture cells for patients enrolled on our cutting-edge clinical trials. The cell products undergo extensive scrutiny and quality control measures to ensure that the patients receive the best cell therapy products possible.
, the laboratory facility director, who serves on international cell therapy committees such as the International Society of Cellular Therapy (ISCT) Immunotherapy committee. Kathy Mintz, an active Foundation for the Accreditation of Cellular Therapy (FACT) and American Association for Blood Banking (AABB) inspector, is laboratory manager, and three nationally-known physician researchers serve as the medical directors. Learn more about
The Stem Cell Processing Laboratory at Children’s National allows us to conduct cutting-edge trials and provide the most innovative care for our patients. The lab is an ISO8 suite with one 4-foot A2 ISO5 biological safety cabinet and one ISO5, 6-foot A2 biological safety cabinet. The suite has dedicated space for supply storage in addition to a sink, water bath, temperature controlled bead bath, -80°C freezer, and standing refrigerator. The facility also includes the following specialized equipment and instruments:
- CliniMACS Cell Separation Device
- Quantum Cell Expansion System
- Sorvall High Speed Centrifuge
CETI’s GMP for Immunotherapy Lab
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 US Food and Drug Administration (FDA). We use the most up-to-date-technology, systems, and equipment to manufacture the highest quality product, according to 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, an undercounter -80°C freezer and 4°C refrigerator, and table top centrifuge for cell isolation.
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 Health System 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)