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

用于稳定和输送疫苗的改变世界的发明的开发和商业化

• 批准号: 52711
• 金额: $ 38.98万
• 依托单位: STABLEPHARMA LIMITED
• 依托单位国家: 英国
• 项目类别: Study
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=52711
• 关键词: Development; commercialisation; world; changing; invention

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'.

疫苗通过将许多传染性、严重和潜在致命疾病（天花/脊髓灰质炎/麻疹/白喉）预防约99.9%，在全球挽救了约300万人的生命\[NHS，2019\]。疫苗通常以液体形式供应，需要在2-8摄氏度之间持续冷藏。全球提供这种冷链的成本为每年3.28亿英镑。重复发生超出推荐范围的温度变化可导致效价不可逆的累积损失。目前，由于冷链能力不足和次优，约50%的疫苗被浪费[WHO，2019]，导致疫苗接种的可用性降低，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150亿英镑的损失。冷链故障源于电力/设备有限，发展中国家距离遥远，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持得过温/过冷）。目前还没有成本效益高的疫苗热稳定方法可用。最先进的解决方案（HydRIS、Arestat和Stabilitech）具有与冷链相关的高成本、较宽的温度范围（-20至45摄氏度）、仅12个月的保质期以及对单个疫苗的定制修改要求的缺点。针头贴片和固体剂量/片剂疫苗输送方法不符合WHO协议。我们Stablepharma Ltd正在开发世界上第一个解决方案“StablevaX”，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/冷链的需要，并消除疫苗浪费。StablevaX是唯一获得专利的（EU-2806854，USA-14/372146）在室温下稳定疫苗24个月的产品（可能更长），并符合世卫组织疫苗管理方案。在过去6年自筹资金的迭代研发的基础上，我们已经证明，StablevaX型破伤风疫苗提供与领先制药公司生产的现有新鲜疫苗相同的抗体应答水平。通过这个为期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StablevaX配方，优化海绵材料/设计，建立ISO 13485生产工艺，生产1000个预装注射器，进行临床前试验，以在CRO（Covance）实现95%的疫苗接种率，并获得监管批准（CE标志，ISO 14155，StablevaX将成为全球疫苗市场的一部分，该市场在2019年价值460亿英镑，预计到2023年将以7%的复合年增长率增长。Stablepharma不是疫苗的制造商/开发商，而是独特系统的提供商，该系统可以以独特的方式提供现有疫苗，而无需冷链，因此我们的目标是与疫苗制造商/制药公司合作，使用基于“每单位交付固定费用”的模式将StablevaX商业化。