search.noResults

search.searching

saml.title
dataCollection.invalidEmail
note.createNoteMessage

search.noResults

search.searching

orderForm.title

orderForm.productCode
orderForm.description
orderForm.quantity
orderForm.itemPrice
orderForm.price
orderForm.totalPrice
orderForm.deliveryDetails.billingAddress
orderForm.deliveryDetails.deliveryAddress
orderForm.noItems
Logistics


of what David Hipkiss, CEO of Enesi Pharma, calls a “shorter term game”. “At the moment it’s a matter of expediency,” he says. “The cold chain challenge is a function of the innate limitation of the formulation of the drug. The fundamental issue is the formulation. If you want to change the game for RNA and go after the big changes, such as the 20% wastage in every multidose vial or the elimination of the cold chain, you don’t address it through the device, you have to address it through the formulation.” And that’s where innovations like Enesi’s come in. The company’s ImplaVax technology combines unit solid-dose formulations with needle-free delivery, keeping vaccines stable at temperatures of up to 40ºC. Hipkiss says solid doses have a range of benefits, not least potency and efficacy, as well as sustainability. “Because our materials are solid precision engineered, we do not have to reconstitute prior to administration, so we don’t have the extra packaging and we don’t have any wasted doses – every dose made is delivered,” he says. The Enesi technology, which is being used for Imperial College London’s SARS-CoV2 RNA vaccine candidate, is transferable across a range of disease states, paving the way for vaccines and other medicines to move past syringe and vial.


All eyes on the device


This model of vaccine delivery requires new ways of thinking. Whereas vial-based doses can be developed and manufactured independently of the syringe, the same does not apply to doses manufactured for a cold chain-free world. “It’s a combination of both formulation and delivery device technologies in their own right – they’re symbiotic and they work together,” says Hipkiss. “We’ve shown that the technology platform is targeted indication agnostic. We have been able to demonstrate the utility of the technology across the broadest possible platform.” Hipkiss believes his company is on the cusp of facilitating the holy grail of vaccine manufacture. Enesi’s technology is “high-potency, thermally stable outside the cold chain in a non-vial, non-syringe, non- reconstitution fashion [and] capable of being delivered in seconds by anyone anywhere in the world”, he notes. “If we link all that up and we make it work – that’s the Apple iPhone moment. If you can do it with that bit of RNA, you can do it with any bit of RNA.” While cold chains will endure due to the limitations of some replacement technologies, Hipkiss foresees a drastic reduction in the current dependency. “I think there will always be a place for the cold chain, but can I conceive of a cold chain-free vaccine world? I think the answer is yes. When will that happen? I think we need to get this first one into a non-needle and syringe format. Once one happens, I think there will be a


Medical Device Developments / www.nsmedicaldevices.com


domino effect – it’s like the first flat screen TV, the first smartphone – someone always has to go first.” Professor Robin Shattock, head of Mucosal Infection and Immunity in the Department of Infectious Disease at Imperial College London, hopes his formulation will be among the first to completely cut out the cold chain. “There remain a number of challenges to address to be able to provide broad coverage against the virus throughout the world population, including in terms of storing, shipping and administering a vaccine at such an unprecedented scale,” he says. “As we make good progress towards evaluating the efficacy of our vaccine, it is critical that in parallel we explore ways to potentially address those challenges, particularly in terms of minimising and ideally eliminating cold chain supply, and the use of needles and syringes, which could be an important barrier to rapid deployment of vaccination efforts globally.”


Enesi’s ImplaVax eliminates the


need for cold storage, as well as the risks and waste associated with needles.


“I think there will always be a place for the cold chain, but can I conceive of a cold chain-free vaccine world? I think the answer is yes.”


David Hipkiss


Hipkiss says that after the devastation of Covid-19, vaccines will be priced on their true value. “It’s true to say that infectious diseases and vaccines were a bit like the ugly sister of the pharmaceutical world until 12 months ago,” he says. “Now, people are seeing their value and companies are piling in.”


Transformative technology Technological developments seen during Covid-19 will further accelerate the move away from cold chains once they are applied to other disease states. “Modern biology has overtaken the norms very quickly,” Hipkiss says. “The RNA genie is out of the bottle and they will begin to apply that technology proactively to disease states that are already endemic.”


In addition to flu and Covid-19 vaccines – possibly as a combined annual single-dose regimen – the focus of RNA technology will move back to oncology and personalised medicine. Hipkiss says that Imperial


180,000


The number of doses stored in Desmon’s prototype deep freeze units, which can maintain temperatures for up to 30 hours without power. Desmon


119


Enesi Pharma


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120  |  Page 121  |  Page 122  |  Page 123  |  Page 124  |  Page 125  |  Page 126  |  Page 127  |  Page 128  |  Page 129  |  Page 130  |  Page 131  |  Page 132  |  Page 133