In:
Stem Cells Translational Medicine, Oxford University Press (OUP), Vol. 2, No. 11 ( 2013-11-01), p. 871-883
Abstract:
Cell therapy is poised to play an enormous role in regenerative medicine. However, little guidance is being made available to academic and industrial entities in the start-up phase. In this technical review, members of the International Society for Cell Therapy provide guidance in developing commercializable autologous and patient-specific manufacturing strategies from the perspective of process development. Special emphasis is placed on providing guidance to small academic or biotech researchers as to what simple questions can be addressed or answered at the bench in order to make their cell therapy products more feasible for commercial-scale production. We discuss the processes that are required for scale-out at the manufacturing level, and how many questions can be addressed at the bench level. The goal of this review is to provide guidance in the form of topics that can be addressed early in the process of development to better the chances of the product being successful for future commercialization.
Type of Medium:
Online Resource
ISSN:
2157-6564
,
2157-6580
DOI:
10.5966/sctm.2013-0050
Language:
English
Publisher:
Oxford University Press (OUP)
Publication Date:
2013
detail.hit.zdb_id:
2642270-0
