Open AccessConcise Review: Making and Using Clinically Compliant Pluripotent Stem Cell Lines
Author(s) -
Carpenter Melissa K.,
Rao Mahendra S.
Publication year - 2015
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.2014-0202
Subject(s) - induced pluripotent stem cell , flexibility (engineering) , embryonic stem cell , human induced pluripotent stem cells , risk analysis (engineering) , stem cell , good manufacturing practice , regenerative medicine , somatic cell , computer science , biochemical engineering , microbiology and biotechnology , business , engineering , biology , biochemistry , statistics , mathematics , regulatory affairs , gene
The challenges in making biological products, starting from tissue sourcing to the processes involved in manufacture, storage, and distribution, are discussed. A model is described that has been proposed by the U.S. NIH for reducing the costs and permitting flexibility and innovation by individual investigators that has the potential to significantly accelerate implementation of pluripotent stem cell therapy.