在病毒尖端蛋白A中,SARS-CoV-2和SARS-CoV的pH无活化来自mAb净化过程中的化物
Hannah Limburg1, Marie Schwerdtner1, Eileen Wilson2
1Institute of Virology, Philipps-University Marburg, 35043, Marburg, Germany.
概括
低pH和高pH治疗有效地在生物制药制造过程中使SARS-CoV-2等包裹病毒失活. 这些病毒失活研究为强大的病毒清除提供了过程设计的信息.
科学领域:
- 生物制药制造业 生物制药制造业
- 病毒学 病毒学
- 过程化学 过程化学
背景情况:
- 生物制药制造业经常使用低pH处理来使包裹病毒失活.
- 用氧化 (高pH值) 清洗的染色学树脂也可以使病毒失活.
- 鼠类白血病病毒是制造过程中评估病毒无活化的模型.
研究的目的:
- 评估SARS-CoV-2和SARS-CoV对低和高pH条件的易感性.
- 在单克隆抗体生产的背景下评估病毒失活.
- 为了比较基于pH的病毒无活化对新型冠状病毒的疗效与其他包裹病毒的疗效.
主要方法:
- 在各种低pH水平 (例如pH3.0,3.4,3.8) 上测试SARS-CoV-2和SARS-CoV无活化.
- 在高pH清洁条件下评估病毒无活化 (约. 13.4) 使用氧化.
- 使用单克隆抗体生产过程中的蛋白A化物质.
主要成果:
- 在pH 3.0时SARS-CoV-2被有效无活化,在pH 3.4时中度无活化,但在pH 3.8时没有被有效无活化.
- 与SARS-CoV-2相比,低pH对于SARS-CoV无活化效果较低.
- 无论是SARS-CoV-2还是SARS-CoV都在高pH值 (大约2小时) 处失活. 13.4.4) 的情况.
结论:
- 低和高pH治疗是生物制药制造中有效的病毒失活策略.
- SARS-CoV-2 显示对低pH无活化的敏感性,为工艺开发提供了信息.
- 这些发现对于在涉及新冠病毒的生物制药生产中确保病毒安全至关重要.
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