Recent studies have reported very low capacity during sterile filtration of glycoconjugate vaccines due to rapid fouling of the sterile filter. The objective of this study was to explore the potential for significantly increasing the capacity of the sterile filter through the use of an appropriate prefilter. Data were obtained using prefilters with different pore size and chemistry, with the sterile filtration performed at constant filtrate flux using 0.22 μm nominal pore size Durapore® polyvinylidene difluoride membranes. Prefiltration through 5 μm pore size Durapore® or Nylon prefilters nearly eliminated the fouling of the sterile filter, leading to more than a 100-fold reduction in the rate of pressure increase for the sterile filter. This dramatic improvement in sterile filter performance was due to the removal of large components (greater than 1 μm in size) as confirmed by dynamic light scattering. These results demonstrate the potential of using large pore size prefilters to significantly enhance the performance of the sterile filtration process for the production of important glycoconjugate vaccines.

中文翻译：

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预过滤提高了糖结合疫苗的无菌过滤性能

最近的研究报告称，由于无菌过滤器的快速结垢，在糖结合疫苗的无菌过滤过程中容量非常低。本研究的目的是探索通过使用适当的预过滤器显着提高无菌过滤器容量的潜力。使用具有不同孔径和化学性质的预过滤器获得数据，并使用 0.22 μm 标称孔径 Durapore® 聚偏二氟乙烯膜在恒定滤液通量下进行无菌过滤。通过 5 μm 孔径的 Durapore® 或 Nylon 预过滤器进行预过滤几乎消除了无菌过滤器的污垢，从而使无菌过滤器的压力增加率降低了 100 倍以上。正如动态光散射所证实的，无菌过滤器性能的这种显着改善是由于去除了大成分（尺寸大于 1 μm）。这些结果证明了使用大孔径预过滤器显着提高用于生产重要糖缀合物疫苗的无菌过滤过程的性能的潜力。