Scale up stem cell culture bioprocess

by Alexey Bersenev on September 20, 2011 · 0 comments

in cell culture, cell product, reviews

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I’d like to share a very good comprehensive review about the bioprocess of scaling up cell culture for clinical applications:

In the past three decades, we have seen the processes for cell-culture biological materials evolve from nascent protocols to mature manufacturing technology. We are likely see similar transformation in the development of stem cell processes in coming years. Although the specifics may differ, the global issues concerning the conversion of laboratory protocols to processes are familiar, ranging from cell development and characterization, medium and process optimization, to cell separation and recovery.

The ultimate goal of converting a laboratory protocol to a process is to enhance the robustness and reduce the cost of goods for the production. For a stem cell process, the optimal conditions for growth or differentiation in the laboratory are not necessarily best for meeting process objectives. For production-scale processes, the controllability, cost, and acceptance by a regulatory agency are all major concerns, in addition to sustaining growth and high efficiency of differentiation.

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