STANDARDIZED EXPANSION OF HUMAN ADIPOSE TISSUE-DERIVED STROMAL/STEM CELLS (hASCs) IN WAVE-MIXED SINGLE-USE BIOREACTORS WITH ONE-DIMENSIONAL MOTION

摘要

The large number of realized and ongoing clinical trials with human mesenchymal stem cells (200 by end of June 2016; www.clinicaltrial.gov) demonstrate their great potential in the field of regenerative medicine. However, new and standardized production technology is necessary to generate the number of cells required at the cell quality desired. The previously used parallelized plastic shells that consist of multiple layers (e.g. stacked plate systems) need to be replaced by instrumented, dynamically-mixed and scalable single-use bioreactors. In these systems the growth surface for the adherent growing cells is provided by microcarriers. While the first users have already worked with stirred single-use bioreactors (e.g. Lonza in Walkersville), there have only been two approaches described in the specialist literature for one-dimensional wave-mixed bioreactors, both of which were not completely successful. This is surprising, since these single-use bioreactors have dominated seed inoculum production for some time due to their uncomplicated operation. Furthermore, wave-mixed single-use bioreactors have proven to be successful in microcarrier-based vaccine production.