The translation of cell-based therapies:clinical landscape and manufacturing challenges

Heathman, Thomas R.J., Nienow, Alvin W., McCall, Mark J., Coopman, Karen, Kara, Bo and Hewitt, Christopher J. (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.

Publication DOI: https://doi.org/10.2217/rme.14.73
Divisions: Life & Health Sciences
Additional Information: This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. Funding: EPSRC
Uncontrolled Keywords: bioreactor,cell-based therapy,clinical trials,manufacture,MSC,regenerative medicine,stem cell,translation,Biomedical Engineering,Embryology
Full Text Link: http://www.futu ... .2217/rme.14.73
Related URLs: http://www.scop ... tnerID=8YFLogxK (Scopus URL)
Published Date: 2015
Authors: Heathman, Thomas R.J.
Nienow, Alvin W.
McCall, Mark J.
Coopman, Karen
Kara, Bo
Hewitt, Christopher J. ( 0000-0001-6988-6071)

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