Product Manufacturing

HSCLabClinical 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 of all products is performed under Good Manufacturing Practice regulations, including 361 products which do not require FDA approval.

External Quality Assurance monitoring is performed by Susan Bolin, Manager, QA for Cellular Therapies.