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The translation of cell-based therapies: clinical landscape and manufacturing challenges
journal contributionposted on 2015-02-23, 11:41 authored by Thomas R.J. Heathman, Alvin W. Nienow, Mark McCall, Karen CoopmanKaren Coopman, Bo Kara, Christopher J. Hewitt
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.
This study has been funded by the Engineering and Physical Sciences Research Council and FUJIFILM Diosynth Biotechnologies.
- Aeronautical, Automotive, Chemical and Materials Engineering
- Chemical Engineering
Published inREGENERATIVE MEDICINE
Pages49 - 64 (16)
CitationHEATHMAN, T.R.J. ... et al, 2015. The translation of cell-based therapies: clinical landscape and manufacturing challenges. Regenerative Medicine, 10 (1), pp. 49 - 64.
PublisherFuture Medicine Ltd / © The Authors
- VoR (Version of Record)
Publisher statementThis work is made available according to the conditions of the Creative Commons Attribution 3.0 Unported (CC BY 3.0) licence. Full details of this licence are available at: http://creativecommons.org/licenses/by/3.0/
NotesThis 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/