Enabling the Scalable Aseptic Manufacturing and In-Vivo Testing of Novel, Solid Unit Dose, Viral Vector Vaccines for Administration by Enesi’s Needle Free ImplaVax® Delivery Technology

通过 Enesi 的无针 ImplaVax® 给药技术实现新型固体单位剂量病毒载体疫苗的可扩展无菌生产和体内测试

• 批准号: 105442
• 金额: $ 110.91万
• 依托单位: ENESI PHARMA LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2019
• 资助国家: 英国
• 起止时间: 2019 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=105442
• 关键词: Enabling; Scalable; Aseptic; Manufacturing; Vivo

Vaccines are one of the most cost-effective ways of delivering lasting benefit to human health and healthcare systems worldwide - it is estimated that they save 9 million lives each year.Today, vaccines are not only being used to prevent common childhood infectious diseases such as measles, polio, and whooping cough. Modern developments in biology have led to the creation of a range of highly targeted vaccines based on vector delivery vehicles such as vaccinia and adenovirus that can be tailored for optimum effectiveness. With such efficiency and specificity, vector-based vaccines are being developed for diseases as broad as influenza, small pox, HIV, other lethal and rare infectious diseases, allergy, biodefence, cancers, and even ultra-personalised medicines tailored to the exact needs of a patient.Most vaccines available today are delivered in a liquid/suspension form with a needle and syringe. Whilst established practice there are significant challenges innate to this presentation including needle-stick injury, cross contamination risk, sharps disposal risk, dosing error, subject pain and stress, poor thermal stability, and excessive wastage.Additionally, multiple injections are generally required to generate a lasting effect on a subjects' immune system. Ensuring an individual's compliance to a 'Prime-Boost' dosing schedule is challenging, especially when dosing is often days if not weeks apart.Enesi has developed a game changing technology that has the potential to revolutionise vaccination worldwide. Rather than delivering a vaccine in the traditional liquid form, our ImplaVax(r) technology allows the facile delivery of highly effective unit solid dose vaccine implants to the subject.Comparative pre-clinical studies using a range of classical vaccines have demonstrated that ImplaVax(r) solid dose vaccines outperform liquid equivalents with a superior and faster immune response, regimen sparing, and enhanced thermal stability. Human factor studies also indicate a strong preference (91%) for the needle-free ImplaVax(r) delivery system across all subject groups evaluated with ease and speed of administration scoring very highly.This project seeks to build on these foundations and will include the development of a robust aseptic-capable solid dose implant manufacturing processes, testing the implants on stability and conducting focused non-clinical immunogenicity studies to demonstrate the performance of the solid dose vaccine in-vivo.Success will give a high confidence that such a process can be applied to all vector-based vaccines with all associated ImplaVax(r) benefits and the potential become a mainstay of both prophylactic and therapeutic treatment in human health.

疫苗是为全球人类健康和医疗保健系统带来持久利益的最具成本效益的方式之一 - 据估计，它们每年挽救900万人的生命。生物学的现代发展导致基于载液和腺病毒等载体输送车的高度靶向疫苗的创建，这些疫苗可量身定制以达到最佳有效性。凭借这种效率和特异性，正在开发基于媒介的疫苗，例如流感，小痘，艾滋病毒，其他致命和罕见的感染性疾病，过敏，生物障碍，癌症，甚至是根据患者的确切需求量身定制的，最大的疫苗可用于液体/悬架形式的液体/悬架形式，并在针对液体的确切需求中量身定制的药物和超级人格化的药物。尽管建立的实践对本演讲有重大挑战，包括针刺损伤，交叉污染风险，尖锐的处置风险，给药错误，受试者疼痛和压力，较差的热稳定性和过度浪费。确保个人遵守“ Prime-nof-nof”给药时间表是具有挑战性的，尤其是当剂量通常是几天（如果不是数周相隔数周）时。Enesi开发了一种改变游戏的技术，有可能在全球范围内彻底改变疫苗接种。我们的Implavax（R）技术不再以传统的液体形式提供疫苗，允许使用一系列经典的经典疫苗来轻松地传递高效的单位固体固体疫苗植入物。人为因素的研究还表明，在所有受试者群体中，对无针的施加（R）递送系统的强烈偏爱（91％），这些群体的评估易于性和高度高度很高。该项目旨在基于这些基础，并将包括稳健的无菌固体固体剂量植入物制造过程的稳定性和固定性的稳定性，从而在植入的稳定性上进行稳定性的效果，从体内核心将高度信心，即可以将这种过程应用于所有具有所有相关的Implavax（R）益处的基于矢量的疫苗，并且潜力成为人类健康中预防性和治疗治疗的支柱。