萨宾无活化脊髓灰质炎疫苗的上游过程开发使用固定床生物反应器技术.
Ahd Hamidi1, Marieke Willemsen1, Thomas Robert2
1Batavia Biosciences B.V., Bioscience Park Leiden, Zernikedreef 16, 2333CL, Leiden, the Netherlands.
Vaccine
|March 4, 2025
概括
使用新型微型设施的非活化脊髓灰质炎疫苗 (IPV) 的区域生产提高了疫苗的可用性. 这种可扩展的工艺提高了效率,并减少了用于脊髓灰质炎根除工作的制造足迹.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 生物工艺工程 生物工艺工程
- 传染病控制和控制传染病
背景情况:
- 脊髓灰质炎根除在医疗保健基础设施有限的地区面临挑战.
- 确保无活化脊髓灰质炎疫苗 (IPV) 的可持续和公平供应对于脊髓灰质炎根除的最后阶段至关重要.
- 现有的脊髓灰质炎疫苗生产方法由于生物安全要求和细胞系特征而面临限制.
研究的目的:
- 开发一个可扩展和高效的区域制造工艺,用于失活的脊髓灰质炎疫苗 (IPV).
- 克服与传统脊髓灰质炎疫苗生产相关的挑战,包括生物安全3级制和Vero细胞系的坚持.
- 为区域疫苗生产创造一个具有成本效益的解决方案,支持疫情防控.
主要方法:
- 开发一种IPV生产工艺,在一个封闭的微型设施内使用Sabin脊髓灰质炎菌株.
- 将触流过器 (TFF) 与固定床生物反应器 (面积150平方米) 集成,以结合生产和度步骤.
- 实施一种完全一次性病毒生产系统,提高工艺效率和减少足迹.
主要成果:
- 通过生物反应器和TFF集成实现了提高工艺效率和减少制造足迹.
- 展示了一个可扩展的生产过程,这是需求驱动的,并使用更少的资源.
- 成功开发了一种用于安全和高效的IPV生产的封闭式微型设施方法.
结论:
- 开发的可扩展的生产过程为区域IPV制造提供了成本效益高的方法.
- 这种方法解决了当前脊髓灰质炎疫苗生产的局限性,促进了公平的获取和供应.
- 该技术适用于区域需求驱动的生产和流行病准备工作.
关键词:
设备开发开发 设备开发固定式生物反应器固定床生物反应器不活化的小儿麻症疫苗商品的低成本是商品的低成本.萨宾减弱的脊髓灰质炎病毒接触式流量过的过方法疫苗 疫苗是一种疫苗.sIPVV 这是一个很好的选择.更多相关视频
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