Industrially Generated Red Blood Cells for Transfusion

Blood Transfusion has become a mainstay of modern medical practice. Problems persist in maintaining supply, managing the risk of transmission of infectious agents and ensuring immune compatibility between donor and recipient. This results in a massive unmet and increasing clinical demand for blood. In the UK alone 2.2 million units of blood are used each year.

Human embryonic stem cells (hES cells) have unique properties in that they can be maintained indefinitely in culture in an undifferentiated state and yet retain the ability to form all the cells and tissues within the body. They offer a potentially limitless source from which to generate red blood cells (RBCs) for use in clinical transfusion. A collaborative research team from the University of Glasgow, Heriot-Watt University, the University of Edinburgh and the University of Dundee has been working on developing and scaling up a process to produce RBCs in suspension culture from hES cells. This will allow the on-demand production of universal donor blood with no risk of human virus transmission.

The work presented here will describe some of the biological and engineering challenges associated with scale-up and purification of the cell culture used to produce the large numbers of RBCs necessary for potential clinical supply. Regulatory and supply chain issues associated with a live cell product will also be discussed since regulatory bodies are likely to require as stringent a demonstration of purity as is currently demanded for protein therapeutics.