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从HEK悬浮液中对Orf病毒进行有效和可扩展的澄清,用于疫苗开发

Felix Pagallies¹, Jennifer J Labisch², Malgorzata Wronska^1,3

¹Department of Immunology, University of Tuebingen, Auf der Morgenstelle 15, 72076 Tübingen, Germany.

|March 25, 2024

概括

优化ORF病毒 (ORFV) 制造,这项研究详细介绍了使用特定过器和收获时间的高效澄清过程. 这一进展对于开发针对疾病和癌症的ORFV疫苗至关重要.

科学领域:

生物技术是生物技术.
病毒学病毒学
疫苗开发疫苗开发

背景情况:

奥尔夫病毒 (ORFV) 显示出作为疫苗载体的潜力,正在进入临床试验.
澄清原始ORFV收获是由于其物理特性而成为一个关键的GMP制造步骤.
现有的ORFV澄清方法需要针对大规模生产进行优化.

研究的目的:

开发和优化一种高效且可扩展的ORF病毒 (ORFV) 来自HEK悬浮培养物的澄清过程.
为了确定ORFV澄清的最佳过材料,孔径,收获时间和核酶处理.
为了解决用于疫苗应用的ORFV的GMP制造方面的挑战.

主要方法:

使用Ambr®交叉流系统进行高通量,小体积选澄清参数.
评估了各种过材料 (例如,基于聚烯的Sartopure® PP3) 和膜孔的大小.
研究了收获时间和核酶处理对ORFV恢复和产量的影响.

主要成果:

确定了基于聚烯的Sartopure® PP3过器作为ORFV澄清的最佳.
建立了一个两阶段的过过程,减少孔径,以增强ORFV恢复.
证明了最佳的收获时间和核酶处理显著增加了ORFV产量.
成功开发了一个可扩展的澄清过程ORFV从悬浮培养.

结论:

使用优化过和收获策略建立了一个高效和可扩展的ORFV澄清过程.
这些发现对于生产基于ORFV的疫苗的良好生产准则至关重要.
优化过程促进了ORFV载体技术在传染病和癌症治疗方面的进步.

关键词:

澄清澄清澄清澄清过器选过器选过器选收获的时间收获的时间多平行过的过方法处理核的处理.帕拉波克斯病毒 Orf

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