title: The applicability of cGMP to cord blood cell banking.
abstract: The Food and Drug Administration will regulate cord blood cells stringently as a distinct category of somatic cells. The FDA has declared that cord blood cell products are subject to licensure and will require a claimed exemption for an investigational new drug (IND) to undertake clinical trials. This regulatory approach will require both establishment and product licenses, requirements that will pose significant difficulties for regulated establishments. The manufacture of cord blood cell products will be divided between delivery rooms or attached laboratories and regional cord cell processing laboratories. It is possible that cooperative manufacturing arrangements, perhaps using a short supply agreement model, will be the most practical way for FDA to regulate cord blood cell product manufacture. Without regard to regulatory or business arrangements for providing cord blood cell products, it is clear that current good manufacturing practices (cGMP) will be required in both the delivery suite and the processing laboratory. The concepts of cGMP will be foreign to many medical practitioners, but embracing them will be crucial to comply with FDA regulatory expectations and will concomitantly ensure uniform product quality.
authors.affiliation: Hoxworth Blood Center, University of Cincinnati Medical Center, OH 45267-0055, USA.
authors.forename: T F
authors.initials: TF
authors.lastname: Zuck
mesh_terms: D001771:Blood Banks / Q000331:legislation & jurisprudence / Q000592:standards*; D017690:Cell Transplantation / Q000592:standards; D002986:Clinical Trials as Topic; D005312:Fetal Blood; D017408:Guidelines as Topic; D006412:Hematopoietic Stem Cells; D006801:Humans; D007231:Infant, Newborn; D008004:Licensure; D014481:United States; D014486:United States Food and Drug Administration