Open AccessConcise Review: Guidance in Developing Commercializable Autologous/Patient‐Specific Cell Therapy Manufacturing
Author(s) -
Eaker Shan,
Armant Myriam,
Brandwein Harvey,
Burger Scott,
Campbell Andrew,
Carpenito Carmine,
Clarke Dominic,
Fong Timothy,
Karnieli Ohad,
Niss Knut,
Van't Hof Wouter,
Wagey Ravenska
Publication year - 2013
Publication title -
stem cells translational medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.781
H-Index - 71
eISSN - 2157-6580
pISSN - 2157-6564
DOI - 10.5966/sctm.2013-0050
Subject(s) - commercialization , process (computing) , scale (ratio) , bench to bedside , product (mathematics) , regenerative medicine , computer science , engineering management , engineering ethics , medicine , risk analysis (engineering) , engineering , business , medical physics , stem cell , marketing , biology , physics , geometry , mathematics , quantum mechanics , genetics , operating system
In this technical review, members of the International Society for Cell Therapy (ISCT) provide guidance in developing commercializable autologous and patient‐specific manufacturing strategies from the perspective of process development. Guidance is provided to help small academic or biotech researchers determine what questions can be addressed at the bench level in order to make their cell therapy products more feasible for commercial‐scale production.