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

疫苗通过预防许多传染性、严重和潜在致命的疾病(天花/脊髓灰质炎/麻疹/白喉)，挽救了全球约300万人的生命[NHS，2019]。疫苗通常以液体形式供应，这需要在2-8摄氏度之间持续冷藏。交付这条冷链的全球成本为3.28亿GB/年。在推荐范围之外反复出现温度变化可能会导致不可逆转的累积效力丧失。目前，约50%的疫苗由于冷链能力不足和不佳而被浪费[世卫组织，2019年]，导致疫苗接种减少，导致全球每年约150万儿童死亡。疫苗浪费每年给全球经济造成约150亿GB的成本。冷链失败的原因是获得电力/设备的机会有限，发展中国家的长途运输增加了冷链过程的压力，以及常见的人为错误(发达国家约37%的医疗保健提供者将疫苗保存得太热/太冷)。目前还没有经济高效的疫苗热稳定方法可用。最先进的解决方案(HydRIS、Arest at和Stbilitech)的缺点是与冷链相关的成本高、温度范围更宽(-20至45摄氏度)、保质期仅为12个月以及对个别疫苗的定制修改要求。微针贴片和固体剂量/片剂疫苗递送方法不符合世卫组织的协议。我们SablePharmma Ltd正在开发世界上第一个解决方案Stable evaX，该解决方案将稳定任何疫苗，使其免受高达45摄氏度的温度波动-消除对冷藏/冷链的需求，并消除疫苗浪费。Stable evaX是唯一一种专利产品(EU-2806854，USA-14/372146)，可使疫苗在室温下稳定24个月(或更长时间)，并符合世卫组织疫苗给药协议。在过去6年自费迭代研发的基础上，我们已经证明，Stable evaX版本的破伤风疫苗可提供与领先制药公司现有新鲜疫苗相同的抗体应答水平-英国国家生物标准与控制研究所-NIBSC的独立评估证实了这一点。通过这18个月的工业研究项目，我们的目标是进一步开发用于TD的Stable-evaX配方，优化海绵材料/设计，建立ISO13485生产流程，生产1000支预装注射器，进行临床前试验以实现GT；CRO(Covance)95%的疫苗接种率并获得监管批准(CE标志、ISO14155、ISO14971)。Stable evaX将成为2019年价值460亿GB的全球疫苗市场的一部分，预计到2023年将以7%的复合年增长率增长。SablePharma不是疫苗制造商/开发商，而是一种独特系统的供应商，该系统可以以独特的方式提供现有疫苗，而不需要冷链，因此我们的目标是与疫苗制造商/制药公司合作，使用基于“每交付单位固定费用”的模式将SablevaX商业化。

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'.