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Publication Detail
Stem cell culture conditions and stability: a joint workshop of the PluriMes Consortium and Pluripotent Stem Cell Platform.
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Article
  • Authors:
    Stacey GN, Andrews PW, Barbaric I, Boiers C, Chandra A, Cossu G, Csontos L, Frith TJ, Halliwell JA, Hewitt Z, McCall M, Moore HD, Parmar M, Panico MB, Pisupati V, Shichkin VP, Stacey AR, Tedesco FS, Thompson O, Wagey R
  • Publication date:
    02/04/2019
  • Journal:
    Regen Med
  • Status:
    Published online
  • Country:
    England
  • Language:
    eng
  • Keywords:
    cell therapy, cell-based medicines, characterization regulation, clinical trial, manufacturing, mesenchymal cells, pluripotent stem cells, regenerative medicine
Abstract
Human stem cells have the potential to transform medicine. However, hurdles remain to ensure that manufacturing processes produce safe and effective products. A thorough understanding of the biological processes occurring during manufacture is fundamental to assuring these qualities and thus, their acceptability to regulators and clinicians. Leaders in both human pluripotent and somatic stem cells, were brought together with experts in clinical translation, biomanufacturing and regulation, to discuss key issues in assuring appropriate manufacturing conditions for delivery of effective and safe products from these cell types. This report summarizes the key issues discussed and records consensus reached by delegates and emphasizes the need for accurate language and nomenclature in the scientific discourse around stem cells.
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