Hematopoietic Stem
Cell Laboratory
Product Manufacturing
Clinical Transplantation Products include autologous and allogeneic hematopoietic progenitor cells derived from bone marrow or peripheral blood (apheresis product), minimally manipulated progenitor cells, positive and negative selection of targeted cells, and allogeneic therapeutic cells (T cells).
Contract manufacturing may be undertaken for investigators with appropriate regulatory approval.
Manufacturing is performed under proposed Good Tissue Practice regulations for cell therapy products that are:
- Not subjected to ex vivo culture or genetic modification
- Used in homologous application
- Not subjected to enrichment or separation of cell subpopulations (other than granulocytes or erythrocytes) using a non-approved device or system.
- Have been determined by the FDA not to require an IND/IDE application
Cells derived from autologous, allogeneic-related or HLA-matched unrelated donors, and otherwise meet the criteria above, are handled following GTP.
Manufacturing is performed under Good Manufacturing Practices for cells that are:
- Cultured or expanded ex vivo
- Used in a non-homologous manner
- Genetically modified
- Are determined to require an IND/IDE application
External Quality Assurance monitoring is performed by Deborah Griffin, Manager, QA for Cellular Therapies.