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Title: Concise review: mind the gap: challenges in characterizing and quantifying cell- and tissue-based therapies for clinical translation
Authors: Rayment, Erin
Williams, David J.
Keywords: Adult stem cells
Cellular therapy
Cell transplantation
Embryonic stem cells
Mesenchymal stem cells
Stem cell transplantation
Issue Date: 2010
Publisher: John Wiley & Sons, Inc © AlphaMed Press
Citation: RAYMENT, E.A. and WILLIAMS, D.J., 2010. Concise review: mind the gap: challenges in characterizing and quantifying cell- and tissue-based therapies for clinical translation. Stem Cells, 28 (5), pp. 996 - 1004.
Abstract: There are many challenges associated with characterizing and quantifying cells for use in cell- and tissue-based therapies. From a regulatory perspective, these advanced treatments must not only be safe and effective but also be made by high-quality manufacturing processes that allow for on-time delivery of viable products. Although sterility assays can be adapted from conventional bioprocessing, cell- and tissue-based therapies require more stringent safety assessments, especially in relation to use of animal products, immune reaction, and potential instability due to extended culture times. Furthermore, cell manufacturers who plan to use human embryonic stem cells in their therapies need to be particularly stringent in their final purification steps, due to the unrestricted growth potential of these cells. This review summarizes the current issues in characterization and quantification for cell- and tissue-based therapies, dividing these challenges into the regulatory themes of safety, potency, and manufacturing quality. It outlines current assays in use, as well as highlights the limits of many of these product release tests. Mode of action is discussed, with particular reference to in vitro surrogate assays that can be used to provide information to correlate with proposed in vivo patient efficacy. Importantly, this review highlights the requirement for basic research to improve current knowledge on the in vivo fate of these treatments; as well as an improved stakeholder negotiation process to identify the measurement requirements that will ensure the manufacture of the best possible cell- and tissue-based therapies within the shortest timeframe for the most patient benefit. STEM CELLS 2010;28:996–1004
Description: Closed access. This article was published in the journal, Stem Cells [John Wiley & Sons, Inc © AlphaMed Press] and the definitive version is available at: http://dx.doi.org/10.1002/stem.416
Sponsor: This work was funded through the UK Engineering and Physical Sciences Research Council-funded Innovative Manufacturing Grand Challenge in Regenerative Medicine (remedi), which is a partnership of Loughborough, Nottingham, Cambridge, Birmingham, Ulster and Liverpool Universities and industry and agency stakeholders.
Version: Accepted for publication
DOI: 10.1002/stem.416
URI: https://dspace.lboro.ac.uk/2134/13378
Publisher Link: http://dx.doi.org/10.1002/stem.416
ISSN: 1066-5099
Appears in Collections:Closed Access (Mechanical, Electrical and Manufacturing Engineering)

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