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Stablepharma edges closer to fridge-free Td vaccine

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Stablepharma CEO, Özgür Tuncer

A biotech company working to eliminate the vaccine cold chain has revealed some promising results from its Tetanus-diphtheria (Td) research programme.

Stablepharma has successfully demonstrated that its reformulated Td vaccine remains stable at 45°c for up to 10 months.

Td-StablevaX-M is a pre-filled disposable syringe containing a dry, stabilised Td vaccine that is injected after rehydration.

The product is a reformulation of Bul Bio’s Tetadif Td vaccine – one of five World Health Organization (WHO) pre-qualified Td vaccines.

Arcadio G. de Castro PhD, Chief Scientific Officer, Stablepharma, explained:

“We have evaluated adjuvant and toxoid integrity as well as in vivo potency.

“Potency tests were carried out under a fully qualified quality system following Pharmacopeia guidelines, and involved evaluation of the protection confered to animals by the vaccine against a lethal dose of the tetanus and diptheria toxins.

“The potency tests are the same as those used for batch release of commercial liquid vaccine, which under the same conditions, were found to completely lose effectiveness”.

Stablevax CEO and executive chairman, Özgür Tuncer, said:

“These results clearly demonstrated that a commercial fridge-free Td vaccine is now within our reach.

“We are moving forward with the development of our first fridge-free vaccine StablevaX-Td, in collaboration with our partners.”

Stablevax technology harnesses the Resurrection Plant, which is adapted to desert life and can survive for years at a time without water.

Vaccines not reliant on the cold chain would be particularly beneficial in warmer countries within the developing world.

Tuncer said:

“By eliminating the need for the cold-chain, fridge-free vaccines could result in health economic savings of up to $100 per patient in low income countries – this in itself is a huge incentive for us to progress our technology with our partners.”

Stablepharma is also working alongside the University of Strathclyde on mRNA stabilisation for Covid-19 vaccines.

In October, Tuncer told Health Tech World that Stablevax technology could be applied to more than 60 vaccines available today.

The CEO said at the time:

“If we can just show the world that we can create a vaccine that’s thermo stable and it’s picked up by likes of Pfizer and Moderna – that would be a massive step for the world.

“But we don’t want to stop there. Covid is just a recent addition to our portfolio of infectious diseases, if you will. But there’s so much more that’s killing people all around the world.”

The WHO estimates that up to 50 per cent of the world’s vaccine supply is wasted each year, in large part due to flaws in the cold chain.

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