Manufacturing research hub for a sustainable future: Vaccines for pandemic preparedness

可持续未来的制造研究中心：预防大流行病的疫苗

• 批准号: EP/X038181/1
• 负责人: Martina Micheletti
• 金额: $ 1566.74万
• 依托单位: University College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=EP%2FX038181%2F1
• 关键词: Manufacturing; research; hub; sustainable; future

The Covid-19 pandemic continues to take a huge toll - an estimated 6.3m people have died including 178,000 in the UK. Globally 1.6bn students have missed school, 250m people will be pushed into extreme poverty and economic losses are estimated at £12tr. History shows that epidemic and pandemic threats constantly emerge, whilst SARS-CoV-2 continues to mutate as it becomes endemic. It is clear that major losses could be prevented by sustained domestic investment in public health. Work undertaken within Vax-Hub1 on responsive technologies and accelerated quality control methods enabled rapid development and manufacture of the ChAdOx1 vectored vaccine against SARS-CoV-2 (licensed for emergency use in December 2020 via a non-profit partnership with AstraZeneca). Over 2.9bn doses have now been released in 180 countries. The UK had a leading role during the pandemic and the proposed Hub builds on this success to advance novel research on a broader range of technologies. Working closely with stakeholders, Vax-Hub will enable the UK to be better prepared for the next pandemic.This investment into The Future Vaccine Manufacturing Hub will enable our vision to make the UK the global centre for vaccine discovery, development and manufacture. The Vaccine Manufacturing Hub brings together a world-class multidisciplinary team with decades of cumulative experience in all aspects of vaccine design and manufacturing research. This Hub will bring academia, industry, not-for-profit organizations and policy makers together to propose radical change in vaccine development and manufacturing technologies, building on a technological innovation culture.The Hub will enhance future vaccine manufacturing through (i) de-risked manufacture of new vaccines by strategically innovating for a selected range of the most promising platform technologies (established and novel/disruptive); (ii) developing manufacturing options that improve the product quality and so immunogenicity; (iii) streamlined manufacturing process development with novel responsive solutions and advanced digitalisation strategies; (iii) a focus on enhancing stability and needle-free administration routes so they become a reality within the lifetime of the Hub. The proposed Hub would be the natural location for early-stage research before projects are transferred to a GMP manufacturing facility.The work focuses on development of improved vaccine platforms which can be flexible enough to be used for multiple product manufacture. These improved vaccine technologies are used as case studies to test rapid and responsive development tools to create a whole process mimicking vaccine manufacture, which could be easily and quickly deployed in case of epidemic/pandemic scenario. Finally the research focuses on standard and novel adjuvants to make mucosal delivery a reality, thus allowing alternative route to injection for mass administration.The Hub will establish the UK as the global centre for end-to-end vaccine research and manufacture. Additionally, vaccines should be considered a national security priority, as it is evident that diseases do not respect international boundaries, thus this work into capacity building and rapid response is a significant advantage. The impact of this Hub will be felt internationally, as the UK reaffirms its leadership in Global Health and works to ensure that the outputs of this Hub reach the global community and the most vulnerable, especially children.

新冠肺炎（COVID-19）大流行继续造成巨大损失--估计已有630万人死亡，其中包括英国的17. 8万人。全球有16亿学生失学，2.5亿人将陷入极端贫困，经济损失估计为12万亿英镑。历史表明，流行病和大流行的威胁不断出现，而SARS-CoV-2在成为地方性流行病时继续变异。显然，如果国内持续投资于公共卫生，就可以避免重大损失。Vax-Hub 1在响应技术和加速质量控制方法方面开展的工作使针对SARS-CoV-2的ChAdOx 1载体疫苗的快速开发和生产成为可能（通过与阿斯利康的非营利合作伙伴关系，于2020年12月获得紧急使用许可）。目前已在180个国家发放了超过29亿剂疫苗。英国在大流行期间发挥了领导作用，拟议的中心将在此成功的基础上推进更广泛技术的创新研究。Vax-Hub将与利益相关者密切合作，使英国能够更好地为下一次大流行做好准备。对未来疫苗制造中心的投资将使我们的愿景成为全球疫苗发现，开发和制造中心。疫苗生产中心汇集了一支世界一流的多学科团队，在疫苗设计和生产研究的各个方面积累了数十年的经验。该中心将把学术界、工业界、非营利组织和政策制定者聚集在一起，在技术创新文化的基础上，提出疫苗开发和制造技术的根本变革。该中心将通过以下方式加强未来的疫苗制造：（i）通过对选定的一系列最有前途的平台技术进行战略创新，降低新疫苗制造的风险（ii）开发可提高产品质量和免疫原性的生产选择;（iii）采用新型响应解决方案和先进的数字化策略简化生产工艺开发;（iii）重点加强稳定性和无针给药途径，以便在中心的生命周期内成为现实。拟议的中心将成为项目转移到GMP生产设施之前进行早期研究的自然地点。该工作重点是开发改进的疫苗平台，这些平台可以足够灵活，可用于多种产品生产。这些改进的疫苗技术被用作案例研究，以测试快速响应的开发工具，以创建模拟疫苗制造的整个过程，在流行病/大流行的情况下可以轻松快速地部署。最后，研究重点是标准和新型佐剂，使粘膜递送成为现实，从而为大规模注射提供替代途径。该中心将使英国成为端到端疫苗研究和制造的全球中心。此外，疫苗应被视为国家安全的优先事项，因为疾病显然不受国际边界的限制，因此这项能力建设和快速反应的工作是一个重大优势。该中心的影响将在国际上感受到，因为联合王国重申其在全球卫生方面的领导地位，并努力确保该中心的产出惠及全球社会和最弱势群体，特别是儿童。

项目成果

Increasing Understanding of the Role of Engineering in Vaccine Development and Manufacture. A Collaborative Project between Ucl-Oxford Future Vaccine Manufacturing Research Hub (Vax-Hub) and UK Secondary Schools

加深对工程在疫苗开发和制造中的作用的理解。

• DOI: 10.2139/ssrn.4586086
• 发表时间: 2023
• 期刊: SSRN Electronic Journal
• 作者: Micheletti M

Investigation of the impact of probes and internals on power and flow in stirred tank reactors

研究搅拌釜反应器中探头和内部构件对功率和流量的影响

• DOI: 10.1016/j.ces.2023.119683
• 发表时间: 2023
• 期刊: Chemical Engineering Science
• 影响因子: 4.7
• 作者: Charalambidou A

Platform development for high-throughput optimization of perfusion processes-Part II: Variation of perfusion rate strategies in microwell plates

灌注过程高通量优化的平台开发第二部分：微孔板灌注速率策略的变化

• DOI: 10.1002/bit.28685
• 发表时间: 2024
• 期刊: Biotechnology and Bioengineering
• 影响因子: 3.8
• 作者: Dorn M

Design and characterization of a novel perfusion reactor for biopharmaceuticals production

用于生物制药生产的新型灌注反应器的设计和表征

• DOI: 10.1016/j.cherd.2023.04.066
• 发表时间: 2023
• 期刊: Chemical Engineering Research and Design
• 影响因子: 3.9
• 作者: Tregidgo M

Platform development for high-throughput optimization of perfusion processes: Part I: Implementation of cell bleeds in microwell plates

• DOI: 10.1002/bit.28682
• 发表时间: 2024-02-23
• 期刊: BIOTECHNOLOGY AND BIOENGINEERING
• 影响因子: 3.8
• 作者: Dorn，Marie;Klottrup-Rees，Kerensa;Micheletti，Martina
• 通讯作者: Micheletti，Martina