稳定性研究用于确定Orf病毒制药生产的关键过程参数
Friederike Eilts1, Jennifer J Labisch2, Sabri Orbay1
1Institute of Bioprocess Engineering and Pharmaceutical Technology, University of Applied Sciences Mittelhessen (THM), Wiesenstr.14, 35390 Giessen, Germany.
Vaccine
|June 23, 2023
概括
新型疫苗平台Orf病毒在各种压力条件下表现出强大的传染性. 这项研究确定了其生产和配方的关键参数,支持疫苗开发.
科学领域:
- 病毒学 病毒学
- 疫苗学 疫苗学 疫苗学
- 生物加工是一种生物加工.
背景情况:
- 奥尔夫病毒 (Orf virus) 是一种帕拉波克斯病毒,是疫苗开发的有希望的病毒载体.
- 目前正在进行基于Orf病毒的疫苗的I期临床试验.
- 强大的生产流程对于疫苗平台的可行性至关重要.
研究的目的:
- 确定影响Orf病毒传染性的关键过程参数.
- 为了评估Orf病毒在热,pH,化学和机械压力下的稳定性.
- 为Orf病毒疫苗开发稳定的药物配方提供信息.
主要方法:
- 对Orf病毒进行了强制降解研究.
- 测试包括热,pH,化学 (离子强度,缓冲) 和机械应力.
- 在各种压力条件下测量病毒感染力.
主要成果:
- 奥尔夫病毒在pH值5 - 7.4之间以及常见的缓冲剂中保持感染力.
- 与高达0.5M的NaCl和MgCl2观察到稳定性,但NH4Cl导致了不稳定.
- 该病毒对短期热量 (37°C),结解周期和低剪压表现出弹性,但对超声波敏感.
结论:
- Orf病毒表现出广泛的传染性稳定性,对于生产过程优化至关重要.
- 了解这些参数有助于创建稳定的基于Orf病毒的疫苗配方.
- 这些发现与用于疫苗载体的包裹式大型DNA病毒有关.
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