Human mesenchymal stem cells (MSCs) hold great promise for clinical use and cell therapy applications. To ensure highest quality and safety of the resulting cellular products, MSCs have to be maintained using standardized cultivation conditions and procedures. To this end, we have developed our xeno-free MSC-Brew GMP Medium following the recommendations of USP <1043> on ancillary materials, thus enabling isolation and expansion of MSCs from various tissue sources (e.g. human bone marrow, adipose tissue, and umbilical cord). To increase the level of process standardization and product safety we developed a procedure using the integrated cell processing platform CliniMACS Prodigy® for i) density gradient centrifugation (DGC) of human bone marrow, ii) cultivation of MSCs starting from bone marrow mononuclear cells (BM-MNCs), and iii) passaging of MSCs. MSCs from human bone marrow were isolated by plastic adherence using MSC-Brew GMP Medium and automated feeding and harvesting procedures in a closed, single-use tubing set. Subsequently, these cells could be replated and expanded within the closed system, illustrating the feasibility of an automated cell production.

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