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In Swansea, project lead Dr Sanjiv Sharma says going down the patch route could serve a dual purpose. “The primary goal of this project is to create a prototype of a smart vaccine delivery device that can not only deliver the Covid-19 vaccine transdermally, but also monitor biomarkers in the skin in a minimally invasive way, offering real- time information on the efficacy of the vaccination.” Sharma says such technology could transform the way clinical trials are conducted.


Enesi and other companies around the world are paving the way for medicines to move past syringes and vials.


College is just one of the “far-sighted” companies and research outfits working with Enesi to develop solid dose medicines. But Enesi is not alone in exploring technologies that could consign cold chain-dependent vaccines to history. Portland-based start-up StoneStable is looking at the viability of coating viruses in silica, which would dissolve in the bloodstream. “On the molecular level, we’re working at building a kind of ‘nanofridge’ around a drug particle to prevent it from becoming inactive,” StoneStable founder Professor Ken Stedman told the journal Pharmacy & Therapeutics in 2018. “The pharmaceutical company would integrate these particles, our proprietary technology, into its existing drug-manufacturing process. This would remove refrigeration from the equation and allow the vaccine to survive at room temperature.”


“People, countries and systems have been forced to look at vaccine manufacture and distribution in a way they haven’t done before.”


David Hipkiss


Meanwhile, Michigan-based Esperovax has an mRNA pill it hopes will eventually allow self-administration of vaccines, though questions remain over the potency and long-term efficacy of oral vaccines. Esperovax is one of four companies benefiting from US government Biomedical Advanced Research and Development Authority (BARDA) funding to explore skin and pill- based Covid-19 vaccine technologies. In Boston, Vaxess Technologies has a vaccine patch – based on silkworm fibre technology – that’s being developed for both Covid-19 and influenza. The University of Connecticut and California’s Verndari, meanwhile, are also working on so-called ‘smart patches’ based on microneedle technology. Outside the US, teams at Tohoku University in Japan and Swansea University in Wales are also developing skin-based vaccine devices.


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A step in the right direction However, it’s not just vaccines, but also lab work that’s moving away from the cold chain. EKF Diagnostics’ PrimeStore MTM device stabilises and preserves sample RNA for up to seven days at ambient temperatures, allowing it to be transported and processed outside of containment. The device has come into its own during the pandemic, taking pressure off labs that do not have the capacity to refrigerate large volumes of Covid-19 test samples onsite. It also reduces time and cost constraints for transportation because samples can be sent via the postal system rather than requiring specialist couriers. “Covid-19 has demonstrated just how much healthcare relies on the cold chain to carry out its everyday business,” says Rebekah Stibbs, product manager for the PrimeStore MTM. “I think it shone a light on the everyday demands the medical sector faces that the public had not appreciated previously.” Stibbs predicts the device will play a key role in the future of diagnostics as home sample collection kits become more widely used. She agrees with Hipkiss that there will always be cold chain requirements for some products and services, but says there has been an awakening in terms of innovation.


“Covid-19 has highlighted the need to move quickly and easily when fighting a global emergency,” she says. “Anything that speeds up the process must be seen as a positive, and removing the reliance on an expensive and complex part of the sampling process must surely be seen as a step in the right direction.” Hipkiss agrees that Covid-19 has awakened the world to the fallibility of the cold chain. “People, countries and systems have been forced to look at vaccine manufacture and distribution in a way they haven’t done before or – perhaps more correctly – they’ve chosen to ignore,” he says. “Plenty of people on our side of the bargain have been banging on about this for a long time now, but saying ‘I told you so’ doesn’t get you anywhere. What we’re focused on is saying ‘let’s look at doing it this way rather than the way we’ve always done it’. If you always do what you’ve always done, you’re going to end up back in exactly the same place.” ●


Medical Device Developments / www.nsmedicaldevices.com


Enesi Pharma


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