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

Authors:
Baghbaderani BA, Tian X, Neo BH, Burkall A, Dimezzo T, Sierra G, Zeng X, Warren K, Kovarcik DP, Fellner T, Rao MS
In:
Source: Stem Cell Reports
Publication Date: (2015)
Issue: 5(4): 647-659
Research Area:
Stem Cells
Cells used in publication:
CD34+ cell, human
Species: human
Tissue Origin: blood
Platform:
4D-Nucleofector™ X-Unit
Experiment
Authors addressed the challenges related to the generation of iPSCs under current good manufacturing practice (cGMP) compliant conditions, including tissue sourcing, manufacturing, testing, and storage. Here they describe their efforts to develop a process for the reprogramming of CD34+ cells into iPSC to generate master cell banks (MCBs) under cGMP. For cultivation Lonza’s L7 Culture System was used and the reprogrammed cells were also characterized and differentiated into several tissues afterwards. Although Lonza’s L7 medium as a standard product is just research grade, in case it is necessary a clinical grade version can be available as a custom production.
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.