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Stem Cell Reports. 2015 Oct 13;5(4):647-59. doi: 10.1016/j.stemcr.2015.08.015. Epub 2015 Sep 24.

cGMP-Manufactured Human Induced Pluripotent Stem Cells Are Available for Pre-clinical and Clinical Applications.

Author information

1
Lonza Walkersville, Inc., Walkersville, MD 21793, USA.
2
XCell Science, Inc., Novato, CA 94947 USA.
3
XCell Science, Inc., Novato, CA 94947 USA; Buck Institute for Age Research, Novato, CA 94945, USA.
4
Lonza Walkersville, Inc., Walkersville, MD 21793, USA. Electronic address: thomas.fellner@lonza.com.
5
Q Therapeutics, Salt Lake City, UT 84108, USA. Electronic address: rao1789@gmail.com.

Abstract

The discovery of induced pluripotent stem cells (iPSCs) and the concurrent development of protocols for their cell-type-specific differentiation have revolutionized our approach to cell therapy. It has now become critical to address the challenges related to the generation of iPSCs under current good manufacturing practice (cGMP) compliant conditions, including tissue sourcing, manufacturing, testing, and storage. Furthermore, regarding the technical challenges, it is very important to keep the costs of manufacturing and testing reasonable and solve logistic hurdles that permit the global distribution of these products. Here we describe our efforts to develop a process for the manufacturing of iPSC master cell banks (MCBs) under cGMPs and announce the availability of such banks.

PMID:
26411904
PMCID:
PMC4624993
DOI:
10.1016/j.stemcr.2015.08.015
[Indexed for MEDLINE]
Free PMC Article

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