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Prokarium and Probiomed team to scale-up thermostable oral vaccine

Dan Stanton

By Dan Stanton+

04-Jan-2017

Bacteria such as Shigella, enterotoxigenic E. coli (ETEC) and Non-Typhoidal Salmonellosis account for 1 billion cases of diarrhoea yearly. Image: iStock/Dr_Microbe
Bacteria such as Shigella, enterotoxigenic E. coli (ETEC) and Non-Typhoidal Salmonellosis account for 1 billion cases of diarrhoea yearly. Image: iStock/Dr_Microbe

The project funded by the UK and Mexican governments will look to prove the scalability of Prokarium’s oral vaccine platform, the firm says.

UK-based biotech firm Prokarium will use its Vaxonella oral vaccine technology with Mexican biopharma firm Probiomed’s production and testing capabilities to look at scaling-up the manufacture of an orally administered vaccine to prevent diarrhoea.

According to Prokarium CEO Ted Fjällman, the Vaxonella platform has already been proven to produce stable oral vaccines at a temperature of 40⁰C for up to 12 weeks at a 50-100L scale.

Currently only the meningitis A vaccine MenAfriVac has been shown to remain stable at such temperature and only for up to four days, he told Biopharma-Reporter.com.

“If we can show successful scale-up with this diarrhoea vaccine then we can do this with any Vaxonella vaccine.”

The project is being co-funded by the British and Mexican governments, with the Innovate UK paying Prokarium through the Newton Fund, while the Mexican government’s innovation agency CONACYT will support Probiomed’s investment in required equipment and capacity.

Vaxonella platform and vaccine manufacture

Vaccines produced by Prokarium’s platform are swallowed and dissolve in the small intestine, releasing safe bacteria, Fjällman explained.

These bacteria naturally cross the gut lining and are taken up by the body's immune cells. The bacteria then - and only then - start to produce vaccine at very low doses. The low doses are sufficient to raise an immune response with little or no side effects, because they are right where you'd want them to be: inside the body's own immune cells.”

As for manufacturing, the process is relatively simple he said, with the bacteria grown, spun down and washed.

The issue is with the lyophilisation process which determines the stability of the finished vaccine, but according to Fjällman, Prokarium uses various undisclosed excipients to aid this.

“We use a very standard process and common freeze-drying protocol. The innovation lies in the genetic manipulation of the bacteria, and finding the right excipients to stabilise the product. Once scale-up is proven, any [licensed] manufacturer will be able to reproduce this.”

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