Bacterial Retention During Filtration of a Live Attenuated Virus Vaccine Through the Sartobran P Sterile Filter
Bacterial Retention During Filtration of a Live Attenuated Virus Vaccine Through the Sartobran P Sterile Filter
复制标题
通过 Sartobran P 无菌过滤器过滤减毒活病毒疫苗期间的细菌截留
DOI：
10.1016/j.xphs.2022.03.022
复制
发表时间：
2022
影响因子：
3.8
通讯作者：
Zydney, Andrew L.
中科院分区：
文献类型：
--
作者：
Taylor, Neil;Morris, Matt;Wee, Alex;Ma, Wanli;Kristopeit, Adam;Wang, Sheng-ching;Zydney, Andrew L.
最近对减毒活病毒（LAV）进行的无菌过滤研究表明，Sartobran P无菌过滤器可提供80%的100 - 400 nm大小的LAV产率，这引发了关于该过滤器在保留标准挑战细菌缺陷短波单胞菌方面的有效性的问题。本研究评价了B.在适合于LAV过滤的条件范围内减少Sartobran P。B.通过动态光散射（DLS）、纳米颗粒跟踪分析（NTA）和扫描电子显微镜对缺陷进行表征。Sartobran P显示出B的完全保留。在所有条件下，即使在存在添加剂如蔗糖、表面活性剂和高盐的情况下，也会产生细菌缺陷，这些添加剂先前被假设会增加细菌突破的风险。B的大小。当在ASTM挑战试验所要求的营养贫乏培养基中孵育时，蔗糖的加入引起了NTA测量的尺寸的进一步减小，尽管这是由于细胞运动性的增加。在LAV或B的高载量下没有细菌突破的证据。这进一步证明了Sartobran P用于大型病毒疫苗无菌过滤的有效性。
Recent studies of sterile filtration of a Live Attenuated Virus (LAV) demonstrated that the Sartobran P sterile filter provided 80% yield of a LAV that was 100 – 400 nm in size, raising questions about the effectiveness of this filter in retaining the standard challenge bacterium,Brevundimonas diminuta. This study evaluated the retention ofB. diminutaby the Sartobran P over a range of conditions appropriate for LAV filtration. TheB. diminutawere characterized by dynamic light scattering (DLS), nanoparticle tracking analysis (NTA), and scanning electron microscopy. The Sartobran P showed complete retention ofB. diminutaunder all conditions, even in the presence of additives like sucrose, surfactants, and high salt that have previously been hypothesized to increase the risk of bacterial breakthrough. The size ofB. diminutadecreased when incubated in the nutrient poor media required by the ASTM challenge test. The addition of sucrose caused a further reduction in size as measured by NTA, although this was due to an increase in cell motility. There was no evidence of bacterial breakthrough at high loadings of either the LAV orB. diminuta, further demonstrating the effectiveness of the Sartobran P for sterile filtration of large viral vaccines.