it is astronomical, and i can not see them revolutionising regenerative medicine in the way Bloomberg talks about with this kind of pricing.
Bring on Cymerus and the cost/pricing equation changes dramatically.
You only have to look at the Cynata website or the youtube video to see the pros and cons of Cymerus vs older methods of producing MSC's
Key Features of the Cymerus™ Technology:
Versatility
MCAs can be used to make a range of cell types, each of which has different properties and may be suited to the treatment of different diseases. In the first instance, Cynata is using MCAs as the basis for producing commercially relevant quantities of very pure and well characterised mesenchymal stem cells (MSCs). Cynata believes that it will be able to produce cells much more efficiently than companies using adult stem cell technology. Manufacturing scaleability
As cells mature, they become less and less “expandable”. So, MSCs derived from adult tissues have a limited expansion capacity, meaning that manufacturers constantly need to be identifying, qualify and screening new cell donors. This is an expensive and time-consuming process.
Cynata manufactures its MCAs – and in turn MSCs – using induced pluripotent cells (iPSCs) as a starting material. Pluripotent cells are immortal – effectively, meaning that they have infinite expansion capacity. Consequently, Cynata expects to be able to source all of the cells it will ever need from a single donor. Furthermore, it means that Cynata does not need to excessively expand MSCs in culture in order to produce large numbers of doses. This is important, as excessive culture expansion has been shown to result in changes in the functionality of MSCs. Manufacturing costs and complexity
Because Cynata will develop its products from a pluripotent cell source, it will be able to eliminate the need to repeatedly source, screen and qualify new donors. This will substantially reduce the costs and complexity of manufacturing.
In addition, Cynata expects to have far fewer batch-to-batch variability issues, since all of its cellular material will be sourced from a single donor. Clinical predictability
Inevitably, batches of cells produced from different donors will have different properties. Cynata’s expected reduced batch-to-batch variability may increase the predictability of clinical outcomes.
This will need to be confirmed in clinical trials. Safety
MSCs are immunoprivileged, meaning that they can generally be infused or injected into recipients without provoking a dramatic immune response. However, antibodies to injected cells have been detected in some clinical trials. One reason for this may be the presence of non-immunoprivileged contaminating cells, left over from the process of extracting and purifying cells from adult donors.
Cynata’s cells are manufactured from iPSCs, rather than being purified from adult sources. Consequently, it is expected that the level of purity of Cynata’s cell products will be extremely high, which may translate into a lower likelihood of stimulating an immune response in the recipient.
CYP Price at posting:
34.0¢ Sentiment: Buy Disclosure: Held
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