Development Of An Optimized Lentiviral Transduction Medium And Process To Manufacture Genetically Modified MSC Working Cell Banks

A critical challenge to engineered MSC therapeutic products is the historically low transduction efficiency of primary cells. Translating poor efficiency into cGMP manufacturing results in high costs, poor control, and inconsistent product quality. Our goal was to simplify the optimization of MSC genetic modification. We optimized the liquid reagent for maximum transduction efficiency and are offering it as an off-the-shelf medium, RoosterGEM™, for transduction/transfection. We then identified a small set of key process parameters to optimize that are project specific.
We report here the development of a chemically defined, animal component free Genetic Engineering Medium (RoosterGEM™), and a robust process to manufacture scalable genetically modified hMSC Working Cell Bank (WCB) vials using lentiviral vectors.
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