Development of a fridge-free thermostabilised tetanus diphtheria (Td) vaccine

疫苗通过预防许多传染性、严重和潜在致命的疾病，包括天花、脊髓灰质炎、麻疹和白喉，每年在全球挽救约300万人的生命。疫苗通常以液体形式供应，需要在2至8°C之间持续冷藏。根据联合国儿童基金会的数据，使用温控供应链（称为冷链）运送疫苗每年的成本约为3.64亿英镑。温度变化超出推荐范围的反复发作可能导致疫苗效力不可逆转的累积损失。据世卫组织称，目前约有一半的疫苗由于冷链能力不足和次优而被浪费。这导致疫苗接种的可用性减少，导致全球每年约150万可避免的儿童死亡。此外，疫苗浪费每年给全球经济造成约190亿英镑的损失。生产耐热疫苗代表了冷链故障问题的最佳解决方案。然而，目前没有成本有效的疫苗热稳定方法，并且几乎没有热稳定疫苗可用。最先进的解决方案（HydRIS、Arktek、Arestat和Stabilitech）存在与冷链相关的高成本、不到一年的较低保质期以及针对单个疫苗的定制工艺修改要求等缺点。Stablepharma正在开发一种平台技术“SPVX 02”（新型配方和冻干工艺），以使最广泛使用的疫苗在高达45摄氏度的温度下稳定12个月。SPVX 02最初是根据世卫组织关于人道主义需求的指导方针为破伤风白喉（Td）开发的，目标市场更大（每年2.36亿剂）和更高的每剂价值。通过最近成功完成的英国创新资助项目（\#52711），Stablepharma开发了符合GMP的生产工艺，并通过预试验验证了SPVX 02稳定Td疫苗的有效性。临床试验。与南安普顿大学医院合作，这个为期18个月的项目将通过临床研究（n=48）和高档GMP生产工艺将SPVX 02进一步发展到技术就绪水平8，每批生产能力为20，000瓶。

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.