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Large-scale production at an affordable cost is crucial in ensuring commercial viability

Large-scale production at an affordable cost is crucial in ensuring commercial viability

Large-scale production at an affordable cost is crucial in ensuring commercial viability

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Manufacturing

As the number of blood cells per donated unit is vastly in excess of those required for any other cell therapy, extensive red blood cell production is needed to meet demand.  Large-scale production at an affordable cost is crucial in ensuring commercial viability.

With this in mind, Novosang has developed a scalable suspension-based process for the production of red blood cells from adult hematopoietic progenitor cells – early blood cells isolated from the bone marrow. We have successfully scaled this up to produce 1011 red blood cells from these adult stem cells (David Anstee).

A protocol is now being developed that meets good manufacturing process (GMP) guidelines, which will allow the production of red blood cells from human embryonic stem cells (hESCs). We are able to achieve a 95 per cent conversion rate from hESCs to red blood cells, increasing the cell number up to 350,000 fold.

Our recent studies have used a highly cost-efficient micro-bioreactor in which both oxygen and pH can be controlled (Rob Thomas).  Using this system, culture conditions can be adapted to promote optimal maturation and proliferation of red blood cells. This involves the identification of cell markers and environmental changes, caused by nutrient consumption, metabolite production and cell signalling.

Our next aim is to scale up the production of red blood cells from a working cell bank of selected human embryonic and induced pluripotent stem cell lines. We are developing analytical tools to monitor cell behaviour during this scaled-up production. (Nik Willoughby).

In addition, scalable optical and acoustic technologies are being developed to separate out cultured red blood cells to ensure a consistent, pure product. (Mike MacDonald)

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