What patients and families need to know
Cellular Therapy Labs
Children’s National Hospital is dedicated to creating cellular therapy treatments for our patients. We have three labs to perform our research: in our GLP (good laboratory practices) lab, our experts develop new ideas and technology and also perform post-infusion monitoring and tracking of cells in patients. Once these trial ideas are approved for use in patients, they are translated to the Cellular Therapy Lab (CTL), which consists of two labs. The first lab (ISO 8) is for patients receiving a bone marrow transplant (BMT). Cells for BMT patients are processed in a clean room facility specially-designed for stem cell products.
The second lab is our GMP (good manufacturing practices) lab. Here, we manufacture cells for patients enrolled in 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.
Our laboratory team is integrated and led by Patrick Hanley, Ph.D.
, 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 the laboratory manager, and three nationally-known physician researchers serve as the medical directors. Learn more about Allistair Abraham, M.D.
, Catherine Bollard, M.D., MBChB
, and Jennifer Webb, M.D.
BMT’s Stem Cell Processing Laboratory
The Shirley and William Howard Cellular Therapy Laboratory is where our team processes stem cells. This allows us to conduct cutting-edge clinical 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 selection instrumentation
- Flow Cytometry Core
- Quantum Cell Expansion System
- Sysmex Hematology Analyzer
- Nexcelom Cell Counting Device
CETI’s GMP for Immunotherapy Lab
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, 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 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)