Quality assurance and good manufacturing practices for processing hematopoietic progenitor cells.
Hematopoietic progenitor cell processing is now only a part of somatic cell and gene therapy. As these new therapies become used increasingly, it is essential that the new products used to treat patients be as safe and effective as possible. Although progenitor cell processing is still an evolving activity, it is appropriate to introduce standardization and product and process control into the routine laboratory activities. Initial suggestions for quality assurance and good manufacturing practices to accomplish this are presented here. These will need to be modified as experience is gained with progenitor, somatic cell, and gene therapy.
McCullough
J
J
Department of Laboratory Medicine and Pathology, University of Minnesota Hospital, Minneapolis 55455, USA.
D002469:Cell Separation; D018380:Hematopoietic Stem Cell Transplantation / Q000592:standards*; D006412:Hematopoietic Stem Cells; D006801:Humans; D011785:Quality Assurance, Health Care; D014481:United States