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

Overview

Journal Stem Cell Reports

Publisher Cell Press

Specialty Cell Biology

Date 2015 Sep 29

PMID 26411904

Citations 85

Authors

Behnam Ahmadian Baghbaderani

Xinghui Tian

Boon Hwa Neo

Amy Burkall

Tracy Dimezzo

Guadalupe Sierra

Xianmin Zeng

Kim Warren

Don Paul Kovarcik

Thomas Fellner

Mahendra S Rao

Affiliations

Soon will be listed here.

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.

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