Currently, the manufacturing of cell and gene therapy products lags far behind the manufacturing of therapeutic proteins, monoclonal antibodies and small molecule drugs. While the field itself is still rather nascent scientifically, the manufacturing needs for cell and gene therapy products will be different from those required for production of therapeutic proteins, particularly for cell therapy products where the cells are the product.
Critical to the success of all cell therapies is the development of bioprocess methods capable of large-scale, cost-effective, reproducible manufacturing of high-quality cells with uniform and well-defined characteristics.
T-cell therapy products are typically expanded in either static T-flasks (22%), static culture bags (35%), or in rocking motion (aka Wave) bioreactors (43%). Both static flasks and culture bags are quite labor intensive to employ and suffer from mass transfer limitations, particularly oxygen.
The bioreactor in this work provides excellent gas mass transfer, extremely low shear, and the potential for scale up and automation of the cell expansion process, readily producing adequate cell numbers for CAR T-cell or other immuno-oncology therapies or regenerative medicine applications. In this novel, patented (US Patent 8,951,784) and potentially disruptive approach, cells are grown on a matrix suspended in air. This design enables the cells to grow on a 3D matrix/scaffold with a very high surface area per unit volume. Nutrient delivery through the wicking matrix is decoupled from gas delivery so both can be controlled independently.
• Jurkat cells (model T cell line) were cultured in wicking matrix bioreactors
• Integrated, automated bioreactor system was initiated
–Hardware necessary to measure and control temperature, dissolved oxygen, pH and humidity was developed
–The flow system with peristaltic pumps to enable supply and medium exchange and
inoculation was developed
–Work was initiated on the PLC and automated control software
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