Validation and scale up of vaccine stabilization for ambient handling using a pullulan/trehalose

使用支链淀粉/海藻糖进行环境处理的疫苗稳定性验证和规模化

• 批准号: 500188-2016
• 负责人: Filipe, Carlos
• 金额: $ 9.11万
• 依托单位: McMaster University
• 依托单位国家: 加拿大
• 项目类别: Idea to Innovation
• 财政年份: 2016
• 资助国家: 加拿大
• 起止时间: 2016-01-01 至 2017-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=607958
• 关键词: Validation; scale; up; vaccine; stabilization

Developing a technique for safely storing and transporting vaccines is considered the "holy grail" in global health, with huge potential for positive social impact. Current systems rely on "cold" supply chains that are expensive, heavily regulated and require a stable source of energy, to ensure that vaccines are always transported, handled, and stored at controlled temperatures. However, these requirements greatly limit the market access of vaccines, especially to the world's most remote and impoverished regions, while greatly increasing manufacturing costs. Today, our goal is to revolutionize how vaccines are handled. Our team has experimented with a pullulan/trehalose formulation that, once added, encapsulates molecules and protects them from environmental conditions (heat, oxygen). This will allow sensitive reagents - such as vaccines - to be transported and stored at ambient conditions. We have developed a proof-of-concept (in vitro only) using the herpes simplex virus (HSV) as a model system; this performance is a strong proof of concept as HSV, in principle, is more difficult to stabilize relative to other viruses due to its enveloped structure. The goal of this project is to expand the commercial value of our pullulan/trehalose stabilizing technology by a) validating performance in vivo b) assessing technology's ability to stabilize different types of vaccines c) developing scale up and implementation procedures for successful user adoption. All research efforts are directed towards the goal of positioning our technology as an engineering solution and a platform for vaccine stabilization. Our proposed method is easy to use while keeping vaccination procedures the same, does not require extensive capital costs or additional manufacturing steps, and will not require external source of energy during storage or transportation. With cost reduction benefits, combined with the value of solving a global health equity challenge, this technology has great potential for commercial success.

开发安全储存和运输疫苗的技术被认为是全球卫生领域的“圣杯”，具有巨大的积极社会影响潜力。目前的系统依赖于“冷”供应链，这些供应链价格昂贵，监管严格，需要稳定的能源，以确保疫苗始终在受控温度下运输，处理和储存。然而，这些要求极大地限制了疫苗的市场准入，特别是对世界上最偏远和最贫困地区的市场准入，同时大大增加了制造成本。今天，我们的目标是彻底改变疫苗的处理方式。我们的团队已经实验了一种普鲁兰/海藻糖配方，一旦加入，就会包裹分子并保护它们免受环境条件（热量，氧气）的影响。这将允许敏感试剂-如疫苗-在环境条件下运输和储存。我们使用单纯疱疹病毒（HSV）作为模型系统开发了一种概念验证（仅体外）;该性能是一种强有力的概念验证，因为HSV原则上由于其包膜结构而相对于其他病毒更难以稳定。本项目的目标是通过a）验证体内性能B）评估技术稳定不同类型疫苗的能力c）开发成功用户采用的规模扩大和实施程序来扩大我们的普鲁兰/海藻糖稳定技术的商业价值。所有的研究工作都是为了将我们的技术定位为工程解决方案和疫苗稳定平台。我们提出的方法易于使用，同时保持疫苗接种程序相同，不需要大量的资本成本或额外的制造步骤，并且在储存或运输期间不需要外部能源。由于成本降低的好处，加上解决全球健康公平挑战的价值，这项技术具有巨大的商业成功潜力。