Downstream Process Development (DSPD), WuXi Biologics, 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, 200131, China.
Downstream Process Development (DSPD), WuXi Biologics, 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, 200131, China.
Biologicals. 2023 Nov;84:101718. doi: 10.1016/j.biologicals.2023.101718. Epub 2023 Oct 12.
Virus filtration is a robust and effective method to remove potential virus contaminants. Planova 20 N, a virus filter form Asahi Kasei Bioprocess, has been widely used in the manufacturing process of biotherapeutics. Previous studies have shown that parvovirus removal by Planova 20 N can be impacted by low operation pressure and depressurization. Therefore, it is critical to define an operating pressure range for robust virus removal. In this work, the effect of pressure combined with depressurization on virus removal by Planova 20 N was investigated. Our studies showed that effective virus removal can be achieved in the pressure range from 0.7 bar to 1.6 bar. The data also suggest that re-starting with higher pressure after depressurization is highly desirable for large-scale manufacture to mitigate virus leakage risk. In addition, skipping buffer flush post mainstream filtration minimizes the likelihood of depressurization.
病毒过滤是一种去除潜在病毒污染物的有效方法。Asahi Kasei Bioprocess 生产的 Planova 20N 病毒过滤器已广泛应用于生物疗法的生产过程中。先前的研究表明，Planova 20N 对细小病毒的去除效果可能会受到低操作压力和减压的影响。因此，定义一个稳健的病毒去除操作压力范围是至关重要的。在这项工作中，研究了压力与减压联合对 Planova 20N 病毒去除效果的影响。研究结果表明，在 0.7 至 1.6 巴的压力范围内可以实现有效的病毒去除。数据还表明，在减压后以更高的压力重新启动对于大规模生产非常理想，以降低病毒泄漏风险。此外，主流过滤后跳过缓冲液冲洗可以最大限度地减少减压的可能性。
