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首页> 外文会议>Cell culture engineering XV >Nanofiltration as an Effective Means to Prevent Virus Contamination of Cell Culture Processes
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Nanofiltration as an Effective Means to Prevent Virus Contamination of Cell Culture Processes

机译：纳滤是防止病毒污染细胞培养过程的有效手段

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摘要

While cell culture media is typically sterile filtered to remove bacteria and mycoplasma, many bioreactors remain unprotected from viral contamination. As awareness of the risk for viral contamination of cell culture processes grows, manufacturers are seeking virus barrier technologies to remove or inactivate viruses. Filtration is an ideal technology in terms of familiarity, ease of use and scalability. However, hurdles to its implementation remain, most notably, the high cost and large footprints required to implement filters designed for the downstream process and the concern that the small pore size of virus filters could impact cell culture performance. A filter specifically designed for cell culture media could help to overcome these hurdles. A novel virus filter has been designed for chemically defined cell culture media. In this presentation, we show that it has improved capacity over downstream virus filters, as well as high retention of a range of microorganisms, including bacteria, mycoplasma and viruses. We also show that virus filtration has no impact on media composition or cell culture performance. Media was evaluated pre- and post-filtration using liquid chromatography-mass spectrometry, nuclear magnetic resonance and inductively coupled plasma-optical emission spectroscopy. Filtered media was also used in a mAb-producing CHO cell culture process, and cell culture performance was monitored. The resulting protein quality was also evaluated. In all of these evaluations, no significant differences were seen between virus-filtered media and sterile filtered controls, as the graph above exemplifies. In summary, virus filtration has been shown to be a viable technology for reducing the risk of bioreactor virus contamination. By choosing filters designed for the upstream process, efficient and effective protection can be achieved without impacting cell culture performance.
机译：尽管通常将细胞培养基无菌过滤以除去细菌和支原体，但许多生物反应器仍未受到病毒污染的保护。随着人们对细胞培养过程中病毒污染风险的意识日益增强，制造商正在寻求病毒屏障技术来去除或灭活病毒。就熟悉度，易用性和可伸缩性而言，过滤是一种理想的技术。然而，实施该技术的障碍仍然是，实施用于下游工艺的过滤器所需的高成本和大占地面积，以及担心病毒过滤器的小孔径可能影响细胞培养性能。专为细胞培养基设计的过滤器可以帮助克服这些障碍。已经针对化学定义的细胞培养基设计了新型病毒过滤器。在此演示文稿中，我们展示了它具有比下游病毒过滤器更高的容量，以及对多种微生物（包括细菌，支原体和病毒）的高度保留。我们还显示病毒过滤对培养基组成或细胞培养性能没有影响。使用液相色谱-质谱，核磁共振和感应耦合等离子体-光发射光谱法对过滤前后的介质进行评估。过滤的培养基也用于产生mAb的CHO细胞培养过程中，并监测细胞培养性能。还评估了所得的蛋白质质量。在所有这些评估中，如上图所示，在病毒过滤的培养基和无菌过滤的对照之间没有发现显着差异。总而言之，病毒过滤已被证明是降低生物反应器病毒污染风险的可行技术。通过选择为上游过程设计的过滤器，可以在不影响细胞培养性能的情况下实现有效的保护。

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