期刊
VIRUSES-BASEL
卷 13, 期 5, 页码 -出版社
MDPI
DOI: 10.3390/v13050865
关键词
phage; API; magistral preparation; buffers; infusion solutions; infectivity; titer; storage; lyophilization
类别
资金
- Ghent University Hospital
- Flemish government
- University College Ghent by PWO project Quantitative phage control for safe treatment of bacterial invasive species in cystic fibrosis patients (MUCOPHAGE)
- Royal Higher Institute for Defence [HFM 15-5]
- Natural Environment Research Council ACCE DTP Studentship [1517986]
Since 2018, Belgium has allowed the incorporation of phages into magistral preparations for human application, emphasizing the importance of stability for quality and efficacy. Through experiments, it was found that DPBS without Ca2+ and Mg2+ was the best option for preserving phage infectivity, while suspensions with phage concentrations of 7 log pfu/mL were not suitable for storage at 4 degrees C.
In Belgium, the incorporation of phages into magistral preparations for human application has been permitted since 2018. The stability of such preparations is of high importance to guarantee quality and efficacy throughout treatments. We evaluated the ability to preserve infectivity of four different phages active against three different bacterial species in five different buffer and infusion solutions commonly used in medicine and biotechnological manufacturing processes, at two different concentrations (9 and 7 log pfu/mL), stored at 4 degrees C. DPBS without Ca2+ and Mg2+ was found to be the best option, compared to the other solutions. Suspensions with phage concentrations of 7 log pfu/mL were unsuited as their activity dropped below the effective therapeutic dose (6-9 log pfu/mL), even after one week of storage at 4 degrees C. Strong variability between phages was observed, with Acinetobacter baumannii phage Acibel004 being stable in four out of five different solutions. We also studied the long term storage of lyophilized staphylococcal phage ISP, and found that the titer could be preserved during a period of almost 8 years when sucrose and trehalose were used as stabilizers. After rehydration of the lyophilized ISP phage in saline, the phage solutions remained stable at 4 degrees C during a period of 126 days.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据