Billion-Cell Hypoxic Expansion of Human Mesenchymal Stem Cells in BioBLU® 5c Single-Use Vessels

by Khandaker Siddiquee, PhD and Ma Sha, PhD
Volume 14, Issue 2 (Summer 2015)

Stem cell-based regenerative medicine has great potential to advance the therapeutic treatment of human diseases. Among the various stem cell platforms, mesenchymal stem cells (MSCs) represent one of the most promising options. Currently, there are over 500 clinical trials based on MSCs registered at the NIH’s website. Although successful expansion of MSCs in vitro has been well-established, higher-yield, billion-cell expansion of MSCs remains a bottleneck. In this study, we successfully demonstrated large-scale culture of human adipose-derived mesenchymal stem cells (AdMSCs) in an industrial, single-use vessel at 3.75 L scale. The vessel offers a precision-controlled environment for the ideal growth of stem cells under simulated hypoxic physiological conditions. Stem cells and their culture media were monitored, analyzed, and controlled, allowing production of AdMSCs in substantial quantities. At the same time, the specific properties of the stem cell were maintained, as evidenced by stem cell marker assays and differentiation assays performed at the conclusion of the run. Finally, because all steps in the platform were conducted employing single-use consumables, this study demonstrates the fact that the process can be conveniently scaled up to industrial levels of production without having to rely on stainless steel culture facilities...

Siddiquee K, Sha M. Billion-cell hypoxic expansion of human mesenchymal stem cells in BioBLU® 5c single-use vessels. BioProcess J, 2015; 14(2): 22–31.

Posted online July 1, 2015.