Scale-Up Of A Xeno-Free Fed-Batch Stirred-Tank Bioreactor Process For hMSC Manufacturing

By Robert Kirian, Jae Jung, Jason Bishop, Christina Jenkins, Marc Mitchell, Maria Caicedo, Geddy Hamblen, Sean McMillan, Art Hamfeldt, Mark Szczypka, Elie Zakhem, Theresa D'Souza, Quentin Vicard, and Jon Rowley

Human mesenchymal stem/stromal cells (hMSCs) have been investigated in >1500 clinical trials a cross dozens of indications. A robust microcarrier suspension bioreactor process that can be scaled-up is crucial to meet demand for the cGMP manufacturing of hMSC products.

The objective of this study is to scale-up of a Xeno-Free (XF) fed batch microcarrier-based process for hMSC expansion in stirred tank reactors to the 50L scale.