A modular platform for rapid VLP vaccine development and manufacturing for SARS-CoV-2 pandemic response
用于快速开发和制造应对 SARS-CoV-2 大流行的 VLP 疫苗的模块化平台
基本信息
- 批准号:10491854
- 负责人:
- 金额:$ 50万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-01 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
Project Summary: A modular platform for rapid VLP vaccine development and
manufacturing for SARS-CoV-2 pandemic response
This proposal aims to design, develop, and manufacture a virus-like particle (VLP) vaccine for
SARS-CoV-2, and the techniques developed throughout the work can be applied to accelerate
the vaccine pipeline in response to future pandemics. We will generate a VLP expression system
in a HEK 293 host that efficiently creates a consistent VLP product. This production platform was
designed such that the Spike protein characteristic of SARS-CoV-2 can be easily modified,
allowing the vaccine to be modified in response to critical viral mutations. The resulting VLP
production system will be scaled up and used for advanced process development. The VLPs will
be generated in perfusion mode, resulting in a more productive platform with a high product yield.
Successful implementation of perfusion processing for a VLP vaccine will enable other VLP based
products to be more rapidly manufactured using a smaller facility footprint, enabling rapid
manufacturing to meet the global demand. Advanced process analytical technology (PAT) will be
applied to fully characterize the process and product, establishing a baseline Critical Quality
Attribute (CQA) profile to ensure a consistently safe and effective product. Data collected during
process development will be used to generate advanced processing models and robust control
strategies for optimal production of the VLP vaccine. This highly collaborative effort will
demonstrate a rapid, streamlined VLP vaccine development and manufacturing process
that can reduce the time to vaccine rollout as new coronaviruses, coronavirus strains, and
other viral pathogens emerge. Not only will the work proposed here generate a vaccine
candidate for SARS-CoV-2, but the methodology described herein will generate a platform
process for response to future pandemics or potential viral mutations.
项目摘要:快速开发VLP疫苗的模块化平台和
SARS-CoV-2大流行应对措施的制造
该提案旨在设计、开发和制造一种病毒样颗粒(VLP)疫苗,用于
SARS-CoV-2,以及在整个工作中开发的技术可以应用于加速
疫苗流水线以应对未来的大流行。我们将生成一个VLP表达系统
在高效地创建一致VLP产品的HEK 293主机中。这个生产平台是
设计成SARS-CoV-2的刺突蛋白特征可以很容易地修改,
允许对疫苗进行修改以应对关键的病毒突变。由此产生的VLP
生产系统将扩大规模,用于先进工艺开发。VLP将
可在灌流模式下生成,从而获得更高效的平台和更高的产品产量。
VLP疫苗的灌流处理的成功实施将使基于VLP的其他
使用更小的设施占地面积更快地制造产品,从而实现快速
满足全球需求的制造业。高级过程分析技术(PAT)将
应用于全面描述过程和产品,建立基准关键质量
属性(CQA)配置文件,以确保产品始终安全有效。在此期间收集的数据
流程开发将用于生成先进的流程模型和稳健的控制
VLP疫苗最佳生产策略。这一高度协作的努力将
展示快速、简化的VLP疫苗开发和制造流程
这可以减少新冠状病毒、冠状病毒株和
其他病毒病原体也出现了。这里提出的工作不仅会产生疫苗
SARS-CoV-2的候选者,但这里描述的方法将产生一个平台
应对未来大流行或潜在病毒突变的过程。
项目成果
期刊论文数量(0)
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科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Richard Dean Braatz其他文献
Richard Dean Braatz的其他文献
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{{ truncateString('Richard Dean Braatz', 18)}}的其他基金
A modular platform for rapid VLP vaccine development and manufacturing for SARS-CoV-2 pandemic response
用于快速开发和制造应对 SARS-CoV-2 大流行的 VLP 疫苗的模块化平台
- 批准号:
10407278 - 财政年份:2021
- 资助金额:
$ 50万 - 项目类别:
Smart Data Analytics for Risk Based Regulatory Science and Bioprocessing Decisions
基于风险的监管科学和生物加工决策的智能数据分析
- 批准号:
9750316 - 财政年份:2018
- 资助金额:
$ 50万 - 项目类别:
Continuous Viral Vector Manufacturing based on Mechanistic Modeling and Novel Process Analytics
基于机械建模和新颖过程分析的连续病毒载体制造
- 批准号:
9789235 - 财政年份:2018
- 资助金额:
$ 50万 - 项目类别:
Continuous Viral Vector Manufacturing based on Mechanistic Modeling and Novel Process Analytics
基于机械建模和新颖过程分析的连续病毒载体制造
- 批准号:
10001352 - 财政年份:2018
- 资助金额:
$ 50万 - 项目类别:
Smart Data Analytics for Risk Based Regulatory Science and Bioprocessing Decisions
基于风险的监管科学和生物加工决策的智能数据分析
- 批准号:
9693043 - 财政年份:2018
- 资助金额:
$ 50万 - 项目类别:
Smart Data Analytics for Risk Based Regulatory Science and Bioprocessing Decisions
基于风险的监管科学和生物加工决策的智能数据分析
- 批准号:
9976991 - 财政年份:2018
- 资助金额:
$ 50万 - 项目类别:
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