Development and commercialisation of world changing invention for the stabilisation and delivery of vaccines

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Vaccines save ~3million lives globally by preventing many infectious, serious and potentially deadly diseases (smallpox/polio/measles/diphtheria) by ~99.9%\[NHS,2019\]. Vaccines are normally supplied in liquid form which requires constant refrigeration between 2-8 degC. Global cost of delivering this cold-chain is £328million/annum. Repeated episodes of temperature variation outside recommended range can result in an irreversible cumulative loss of potency. Currently ~50% of all vaccines are wasted due to insufficient and suboptimal cold chain capacity \[WHO,2019\], leading to reduced availability of vaccination which causes ~1.5million/annum childhood deaths globally. Vaccine wastage costs ~£15billion/annum to global economy.Cold-chain failure stems from limited access to electricity/equipment, large distances in developing countries adding more pressure to cold-chain process, and common human-errors (~37% of healthcare providers in developed world keeping vaccines too-warm/too-cold). There is currently no cost-effective vaccine thermo-stabilisation method available. State-of-the-art solutions (HydRIS, Arestat and Stabilitech) have disadvantages of high costs related to cold-chain, wider temperature range (-20 to 45degC), shelf-life of only 12months and bespoke modifications requirements for individual vaccines. Microneedles patches and solid-dose/tablet vaccine delivery methods don't comply with WHO protocols.We, Stablepharma Ltd, are developing world's first solution 'StablevaX' which will stabilise any vaccine against temperature fluctuation of up to 45degC - eliminating need for refrigeration/cold-chain and eradicating vaccine wastage. StablevaX is the only patented (EU-2806854, USA-14/372146) product that stabilises vaccines at room temperature for 24 months (and potentially longer) and complies with WHO vaccine administration protocols.Building upon last 6 years of self-funded iterative R&D, we have proven that StablevaX version of Tetanus vaccine delivers same level of antibody response as existing fresh vaccine produced by leading pharmaceutical companies- as confirmed by an independent assessment by UK's National Institute for Biological Standards and Control-NIBSC.Through this 18 months 'industrial-research' project, we aim to further develop StablevaX formulation for Td, optimise sponge material/design, establish ISO13485 manufacturing process to produce 1000 pre-loaded syringes, conduct pre-clinical trials to achieve \>95% vaccination yield at CRO (Covance) and gain regulatory approvals (CE marking, ISO14155, ISO14971).StablevaX will become part of global vaccine market which was valued at £46billion in 2019 and expected to grow @CAGR of 7% till 2023\. Stablepharma are not a manufacturer/developer of vaccine but a provider of a unique system which can deliver existing vaccines in a unique way without the need of cold-chain, therefore we aim to commercialise StablevaX in partnership with vaccine manufacturer/pharmaceutical-companies using a model based upon 'fixed fee per unit delivered'.