Human mesenchymal stem/stromal cells (hMSCs) have been investigated and proven to be a well-tolerated, safe therapy for a variety of indications. To meet the commercial demand for clinical manufacturing of hMSCs, production requires innovative manufacturing technologies such as 3D bioreactors. A robust suspension bioreactor process that can be scaled-up is crucial. This study develops a fed-batch, microcarrier-based bioreactor process, which enhances media productivity and drives a cost-effective and less labor-intensive hMSC expansion process. This process was robust and yielded hMSCs that maintained expansion, phenotypic characteristic, and functional properties. The process can be scaled to the levels needed to meet the commercial demand of hMSCs. Authored by Josephine Lembong, Robert Kirian, Joseph D. Takacs, Timothy R. Olsen, Lye Theng Lock, Jon A. Rowley and Tabassum Ahsan.

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