Automated and digitalised RNA process-in-a-box for rapid outbreak-response disease-agnostic RNA vaccine/therapeutic development and manufacturing at high-quality and low cost

自动化和数字化的盒装 RNA 工艺,用于快速响应疫情、疾病不可知的 RNA 疫苗/治疗药物的高质量和低成本的开发和制造

基本信息

  • 批准号:
    10085632
  • 负责人:
  • 金额:
    $ 254.72万
  • 依托单位:
  • 依托单位国家:
    英国
  • 项目类别:
    Small Business Research Initiative
  • 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

项目摘要

The ribonucleic acid (RNA) vaccine platform technology has been developed for over two decades and has been largely validated during the COVID-19 pandemic. Although this first iteration of RNA vaccines was clinically successful, there is still substantial room for improving the production process to increase production rates and volumes 10-fold, and to reduce manufacturing costs 6-7-fold, whilst maintaining consistently high product quality. The rate at which vaccines against Disease X can be developed and manufactured for large-scale human use is often limited by Chemistry, Manufacturing and Controls (CMC).To remove this CMC bottleneck and to unleash the disease-agnostic platform potential of the RNA technology we are taking a unique and innovative approach which combines the following two synergistic components: 1) design and construct a fully automated continuous RNA-foundry-in-a-box (RNAboxTM) that will allow the manufacturing of both R&D grade and GMP grade materials and 2) develop a bespoke design space based on the Quality by Digital Design (QbDD) framework that will allow the production of the different RNA sequences (translating into different products) using the same automated and continuous RNAbox.The QbDD-enabled RNAbox will provide RNA material for: 1) basic research to study molecular mechanisms, biochemical and cellular signalling pathways as well as disease mechanisms, 2) formulation science studies, 3) studies in animal models and 4) clinical trials. Moreover, it will also provide commercial-scale GMP manufacturing of regulatory-approved products. This will help with epidemic/pandemic preparedness as well as with the development and manufacturing of numerous vaccines against a wide range of diseases.The above will substantially enhance UK's position in RNA vaccine/therapeutic development and manufacturing. In addition, this automated manufacturing technology will not require substantial operator training and will provide high-quality and low-cost RNA material. It will also be suitable for vaccine manufacturing in low- to middle-income countries (LMICs), because of the low-cost (due to efficient raw material use) and lower-skilled manufacturing (due to automation) in lower-grade clean rooms (e.g. EU GMP Grade D, due to the hermetically sealed process). Customers will include vaccine manufacturers, biotechnology companies, pharmaceutical companies, contract (development) manufacturing organizations, research institutes, and academic groups. The global deployment of the QbDD-enabled RNAbox will establish a distributed vaccine and therapeutics manufacturing network which will lead to epidemic/pandemic preparedness and improved health through prevention and treatment of diseases.
核糖核酸(RNA)疫苗平台技术已开发了二十多年,并在COVID-19大流行期间得到了很大程度的验证。尽管RNA疫苗的第一次迭代在临床上是成功的,但仍有很大的空间来改进生产过程,以将生产率和产量提高10倍,并将生产成本降低6-7倍,同时保持一贯的高产品质量。针对X疾病的疫苗的开发和大规模人类使用的生产速度通常受到化学、生产和控制(CMC)的限制。为了消除CMC瓶颈并释放RNA技术的疾病不可知平台潜力,我们正在采取一种独特的创新方法,该方法结合了以下两个协同组件:1)设计并构建全自动连续RNA铸造箱(RNAboxTM),这将允许研发级和GMP级材料的制造和2)开发基于数字设计质量(QbDD)的定制设计空间这一框架将允许产生不同的RNA序列QbDD使能的RNAbox将为以下各项提供RNA材料:1)基础研究,研究分子机制,生物化学和细胞信号通路以及疾病机制,2)配方科学研究,3)动物模型研究和4)临床试验。此外,它还将提供监管批准产品的商业规模GMP生产。这将有助于预防流行病/大流行病以及开发和制造针对各种疾病的多种疫苗,从而大大提高英国在RNA疫苗/治疗药物开发和制造方面的地位。此外,这种自动化制造技术不需要大量的操作员培训,并将提供高质量和低成本的RNA材料。它也将适用于低收入至中等收入国家(LMIC)的疫苗生产,因为低成本(由于有效的原材料使用)和低技能生产(由于自动化)在较低级别的洁净室(例如欧盟GMP D级,由于密封工艺)。客户将包括疫苗制造商、生物技术公司、制药公司、合同(开发)制造组织、研究机构和学术团体。QbDD启动的RNAbox的全球部署将建立一个分布式疫苗和治疗剂制造网络,这将导致流行病/大流行病的准备工作,并通过预防和治疗疾病来改善健康状况。

项目成果

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其他文献

吉治仁志 他: "トランスジェニックマウスによるTIMP-1の線維化促進機序"最新医学. 55. 1781-1787 (2000)
Hitoshi Yoshiji 等:“转基因小鼠中 TIMP-1 的促纤维化机制”现代医学 55. 1781-1787 (2000)。
  • DOI:
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    0
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LiDAR Implementations for Autonomous Vehicle Applications
  • DOI:
  • 发表时间:
    2021
  • 期刊:
  • 影响因子:
    0
  • 作者:
  • 通讯作者:
生命分子工学・海洋生命工学研究室
生物分子工程/海洋生物技术实验室
  • DOI:
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    0
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吉治仁志 他: "イラスト医学&サイエンスシリーズ血管の分子医学"羊土社(渋谷正史編). 125 (2000)
Hitoshi Yoshiji 等人:“血管医学与科学系列分子医学图解”Yodosha(涉谷正志编辑)125(2000)。
  • DOI:
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    0
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Effect of manidipine hydrochloride,a calcium antagonist,on isoproterenol-induced left ventricular hypertrophy: "Yoshiyama,M.,Takeuchi,K.,Kim,S.,Hanatani,A.,Omura,T.,Toda,I.,Akioka,K.,Teragaki,M.,Iwao,H.and Yoshikawa,J." Jpn Circ J. 62(1). 47-52 (1998)
钙拮抗剂盐酸马尼地平对异丙肾上腺素引起的左心室肥厚的影响:“Yoshiyama,M.,Takeuchi,K.,Kim,S.,Hanatani,A.,Omura,T.,Toda,I.,Akioka,
  • DOI:
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    0
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的其他文献

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{{ truncateString('', 18)}}的其他基金

An implantable biosensor microsystem for real-time measurement of circulating biomarkers
用于实时测量循环生物标志物的植入式生物传感器微系统
  • 批准号:
    2901954
  • 财政年份:
    2028
  • 资助金额:
    $ 254.72万
  • 项目类别:
    Studentship
Exploiting the polysaccharide breakdown capacity of the human gut microbiome to develop environmentally sustainable dishwashing solutions
利用人类肠道微生物群的多糖分解能力来开发环境可持续的洗碗解决方案
  • 批准号:
    2896097
  • 财政年份:
    2027
  • 资助金额:
    $ 254.72万
  • 项目类别:
    Studentship
A Robot that Swims Through Granular Materials
可以在颗粒材料中游动的机器人
  • 批准号:
    2780268
  • 财政年份:
    2027
  • 资助金额:
    $ 254.72万
  • 项目类别:
    Studentship
Likelihood and impact of severe space weather events on the resilience of nuclear power and safeguards monitoring.
严重空间天气事件对核电和保障监督的恢复力的可能性和影响。
  • 批准号:
    2908918
  • 财政年份:
    2027
  • 资助金额:
    $ 254.72万
  • 项目类别:
    Studentship
Proton, alpha and gamma irradiation assisted stress corrosion cracking: understanding the fuel-stainless steel interface
质子、α 和 γ 辐照辅助应力腐蚀开裂:了解燃料-不锈钢界面
  • 批准号:
    2908693
  • 财政年份:
    2027
  • 资助金额:
    $ 254.72万
  • 项目类别:
    Studentship
Field Assisted Sintering of Nuclear Fuel Simulants
核燃料模拟物的现场辅助烧结
  • 批准号:
    2908917
  • 财政年份:
    2027
  • 资助金额:
    $ 254.72万
  • 项目类别:
    Studentship
Assessment of new fatigue capable titanium alloys for aerospace applications
评估用于航空航天应用的新型抗疲劳钛合金
  • 批准号:
    2879438
  • 财政年份:
    2027
  • 资助金额:
    $ 254.72万
  • 项目类别:
    Studentship
Developing a 3D printed skin model using a Dextran - Collagen hydrogel to analyse the cellular and epigenetic effects of interleukin-17 inhibitors in
使用右旋糖酐-胶原蛋白水凝胶开发 3D 打印皮肤模型,以分析白细胞介素 17 抑制剂的细胞和表观遗传效应
  • 批准号:
    2890513
  • 财政年份:
    2027
  • 资助金额:
    $ 254.72万
  • 项目类别:
    Studentship
CDT year 1 so TBC in Oct 2024
CDT 第 1 年,预计 2024 年 10 月
  • 批准号:
    2879865
  • 财政年份:
    2027
  • 资助金额:
    $ 254.72万
  • 项目类别:
    Studentship
Understanding the interplay between the gut microbiome, behavior and urbanisation in wild birds
了解野生鸟类肠道微生物组、行为和城市化之间的相互作用
  • 批准号:
    2876993
  • 财政年份:
    2027
  • 资助金额:
    $ 254.72万
  • 项目类别:
    Studentship

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