Vaccines save ~3 million lives globally each year by preventing many infectious, serious, and potentially deadly diseases including smallpox, polio, measles and diphtheria). Vaccines are normally supplied in liquid form which requires constant refrigeration between 2 to 8°C. According to UNICEF, delivering vaccines using a temperature controlled supply chain (known as cold chain) costs approximately £364 million per year. Repeated episodes of temperature variation outside of the recommended range can result in an irreversible cumulative loss of vaccine potency. According to WHO, currently approximately half of all vaccines are wasted due to insufficient and suboptimal cold chain capacity. This leads to reduced availability of vaccination which results in ~1.5 million/annum avoidable childhood deaths globally. Furthermore, vaccine wastage costs ~£19 billion/annum of losses to the global economy. Production of thermostable vaccines represents the optimum solution to the cold chain failure problems. However, there are currently no cost-effective vaccine thermo-stabilisation methods and few thermostable vaccines available. State-of-the-art solutions (HydRIS, Arktek, Arestat and Stabilitech) have disadvantages of high costs related to cold-chain, lower shelf live of less than year and bespoke process-modifications requirements for individual vaccines. Stablepharma is developing a platform technology 'SPVX02' (novel formulation and lyophilisation process) to stabilise most widely used vaccines at temperatures up to 45degC for 12months. SPVX02 is initially being developed for Tetanus-diphtheria (Td) following WHO guidelines on humanitarian needs with a larger target market (236million doses per annum) and higher value per dose. Through recently concluded successful Innovate UK funded project (\#52711), Stablepharma has developing a GMP compliant manufacturing process and validated the efficacy of SPVX02 stabilised Td vaccine through pre-clinical trials. In collaboration with University Hospital of Southampton, this 18months project will further develop SPVX02 to Technology Readiness Level-8 through clinical studies (n=48) and upscale GMP manufacturing process to a capacity of 20,000 vials per batch.

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'.