Industrially Generated Red Blood Cells for Transfusion

Nicholas Willoughby, Fiona Dempsey, Jo Mountford

Research output: Contribution to conferencePaper

Abstract

Blood Transfusion has become a mainstay of modern medical practice. However problems persist both nationally and internationally in maintaining supply, managing the risk of transmission of infectious agents and ensuring immune compatibility between donor and recipient. There is therefore 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 transfusion transmitted infection.
The work presented here will describe some of the biological and engineering challenges associated with scale-up of the cell culture and purification operations used to produce the large numbers of RBCs necessary for potential clinical supply (up to 2x1018 per year). Regulatory and supply chain issues associated with a live cell product will also be discussed since regulatory bodies are almost certain to require as stringent a demonstration of purity as is currently demanded for protein therapeutics.
Although this presentation describes development of a specific process, it is likely that the greatest scale-up hurdles will be specific to cellular therapies as a whole; therefore it is timely to consider process development now in order to prevent a major bottleneck occurring when allogeneic cellular therapies reach clinical trials.
Original languageEnglish
Publication statusPublished - 2012
EventRecovery of Biological Products XV - Stowe, VT, United States
Duration: 29 Jul 20122 Aug 2012

Conference

ConferenceRecovery of Biological Products XV
CountryUnited States
CityStowe, VT
Period29/07/122/08/12

Fingerprint

Erythrocyte Transfusion
Erythrocytes
Bioengineering
Blood Donors
Blood Transfusion
Suspensions
Therapeutics
Cell Culture Techniques
Tissue Donors
Clinical Trials
Infection
Research
Proteins
Human Embryonic Stem Cells

Cite this

Willoughby, N., Dempsey, F., & Mountford, J. (2012). Industrially Generated Red Blood Cells for Transfusion. Paper presented at Recovery of Biological Products XV, Stowe, VT, United States.
Willoughby, Nicholas ; Dempsey, Fiona ; Mountford, Jo. / Industrially Generated Red Blood Cells for Transfusion. Paper presented at Recovery of Biological Products XV, Stowe, VT, United States.
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Willoughby, N, Dempsey, F & Mountford, J 2012, 'Industrially Generated Red Blood Cells for Transfusion', Paper presented at Recovery of Biological Products XV, Stowe, VT, United States, 29/07/12 - 2/08/12.

Industrially Generated Red Blood Cells for Transfusion. / Willoughby, Nicholas; Dempsey, Fiona; Mountford, Jo.

2012. Paper presented at Recovery of Biological Products XV, Stowe, VT, United States.

Research output: Contribution to conferencePaper

TY - CONF

T1 - Industrially Generated Red Blood Cells for Transfusion

AU - Willoughby, Nicholas

AU - Dempsey, Fiona

AU - Mountford, Jo

PY - 2012

Y1 - 2012

N2 - Blood Transfusion has become a mainstay of modern medical practice. However problems persist both nationally and internationally in maintaining supply, managing the risk of transmission of infectious agents and ensuring immune compatibility between donor and recipient. There is therefore 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 transfusion transmitted infection. The work presented here will describe some of the biological and engineering challenges associated with scale-up of the cell culture and purification operations used to produce the large numbers of RBCs necessary for potential clinical supply (up to 2x1018 per year). Regulatory and supply chain issues associated with a live cell product will also be discussed since regulatory bodies are almost certain to require as stringent a demonstration of purity as is currently demanded for protein therapeutics. Although this presentation describes development of a specific process, it is likely that the greatest scale-up hurdles will be specific to cellular therapies as a whole; therefore it is timely to consider process development now in order to prevent a major bottleneck occurring when allogeneic cellular therapies reach clinical trials.

AB - Blood Transfusion has become a mainstay of modern medical practice. However problems persist both nationally and internationally in maintaining supply, managing the risk of transmission of infectious agents and ensuring immune compatibility between donor and recipient. There is therefore 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 transfusion transmitted infection. The work presented here will describe some of the biological and engineering challenges associated with scale-up of the cell culture and purification operations used to produce the large numbers of RBCs necessary for potential clinical supply (up to 2x1018 per year). Regulatory and supply chain issues associated with a live cell product will also be discussed since regulatory bodies are almost certain to require as stringent a demonstration of purity as is currently demanded for protein therapeutics. Although this presentation describes development of a specific process, it is likely that the greatest scale-up hurdles will be specific to cellular therapies as a whole; therefore it is timely to consider process development now in order to prevent a major bottleneck occurring when allogeneic cellular therapies reach clinical trials.

M3 - Paper

ER -

Willoughby N, Dempsey F, Mountford J. Industrially Generated Red Blood Cells for Transfusion. 2012. Paper presented at Recovery of Biological Products XV, Stowe, VT, United States.