Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, Kansas 66047, USA.
J Pharm Sci. 2011 Dec;100(12):5156-73. doi: 10.1002/jps.22724. Epub 2011 Aug 19.
The filoviruses, Ebola virus and Marburg virus, cause severe hemorrhagic fever with up to 90% human mortality. Virus-like particles of EBOV (eVLPs) and MARV (mVLPs) are attractive vaccine candidates. For the development of stable vaccines, the conformational stability of these two enveloped VLPs produced in insect cells was characterized by various spectroscopic techniques over a wide pH and temperature range. Temperature-induced aggregation of the VLPs at various pH values was monitored by light scattering. Temperature/pH empirical phase diagrams (EPDs) of the two VLPs were constructed to summarize the large volume of data generated. The EPDs show that both VLPs lose their conformational integrity above about 50°C-60°C, depending on solution pH. The VLPs were maximally thermal stable in solution at pH 7-8, with a significant reduction in stability at pH 5 and 6. They were much less stable in solution at pH 3-4 due to increased susceptibility of the VLPs to aggregation. The characterization data and conformational stability profiles from these studies provide a basis for selection of optimized solution conditions for further vaccine formulation and long-term stability studies of eVLPs and mVLPs.
丝状病毒,埃博拉病毒和马尔堡病毒,可引起严重的出血热,死亡率高达 90%。病毒样颗粒的 EBOV(eVLPs)和 MARV(mVLPs)是很有吸引力的候选疫苗。为了开发稳定的疫苗,在很宽的 pH 和温度范围内,用各种光谱技术对这两种在昆虫细胞中产生的包膜 VLPs 的构象稳定性进行了表征。通过光散射监测了在不同 pH 值下 VLPs 的温度诱导聚集。构建了两个 VLP 的温度/ pH 经验相图(EPD)来总结生成的大量数据。EPD 表明,两种 VLP 在约 50°C-60°C 以上失去构象完整性,具体取决于溶液 pH 值。在 pH 7-8 的溶液中,VLPs 的热稳定性最高,在 pH 5 和 6 时稳定性显著降低。在 pH 3-4 的溶液中,由于 VLPs 更容易聚集,因此稳定性要差得多。这些研究的表征数据和构象稳定性谱为进一步选择优化的溶液条件提供了基础,以用于 eVLPs 和 mVLPs 的疫苗配方和长期稳定性研究。