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Title: The translation of cell-based therapies: clinical landscape and manufacturing challenges
Authors: Heathman, Thomas R.J.
Nienow, Alvin W.
McCall, Mark J.S.
Coopman, Karen
Kara, Bo
Hewitt, Christopher J.
Keywords: Bioreactor
Cell-based therapy
Clinical trials
Regenerative medicine
Stem cell
Issue Date: 2015
Publisher: Future Medicine Ltd / © The Authors
Citation: HEATHMAN, T.R.J. ... et al, 2015. The translation of cell-based therapies: clinical landscape and manufacturing challenges. Regenerative Medicine, 10 (1), pp. 49 - 64.
Abstract: Cell-based therapies have the potential to make a large contribution toward currently unmet patient need and thus effective manufacture of these products is essential. Many challenges must be overcome before this can become a reality and a better definition of the manufacturing requirements for cell-based products must be obtained. The aim of this study is to inform industry and academia of current cell-based therapy clinical development and to identify gaps in their manufacturing requirements. A total of 1342 active cell-based therapy clinical trials have been identified and characterized based on cell type, target indication and trial phase. Multiple technologies have been assessed for the manufacture of these cell types in order to facilitate product translation and future process development.
Description: This work is published by Future Science and licensed under the Creative Commons Attribution- NonCommercial 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/bync- nd/3.0/
Sponsor: This study has been funded by the Engineering and Physical Sciences Research Council and FUJIFILM Diosynth Biotechnologies.
Version: Published
DOI: 10.2217/RME.14.73
URI: https://dspace.lboro.ac.uk/2134/16781
Publisher Link: http://dx.doi.org/10.2217/RME.14.73
ISSN: 1746-0751
Appears in Collections:Published Articles (Chemical Engineering)

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