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Download fileThe translation of cell-based therapies: clinical landscape and manufacturing challenges
journal contribution
posted on 2015-02-23, 11:41 authored by Thomas R.J. Heathman, Alvin W. Nienow, Mark McCall, Karen CoopmanKaren Coopman, Bo Kara, Christopher J. HewittCell-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.
Funding
This study has been funded by the Engineering and Physical Sciences Research Council and FUJIFILM Diosynth Biotechnologies.
History
School
- Aeronautical, Automotive, Chemical and Materials Engineering
Department
- Chemical Engineering
Published in
REGENERATIVE MEDICINEVolume
10Issue
1Pages
49 - 64 (16)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.Publisher
Future Medicine Ltd / © The AuthorsVersion
- VoR (Version of Record)
Publisher statement
This 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/Publication date
2015Notes
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/ISSN
1746-0751Publisher version
Language
- en