The advantages of liposomes as delivery systems for peptide, protein and DNA vaccines is well-recognised, unfortunately their application has been stinted by their instability during storage and their limited shelf-life. Further, sterilisation of these systems has been problematic, with degradation of the liposomes being reported after sterilisation using the various techniques available. Work form our laboratory has investigated techniques that can be applied to particulate liposomal vaccines such that they can be prepared in a freeze-dried and sterile format. In this article, we describe techniques for the lyophilisation, cryoprotection and sterilisation of liposomal vaccines. Applying these methods allows for the retention of both the chemical integrity of the lipids and the key physico-chemical characteristics of the liposomes (e.g., particle size, zeta potential, and dynamic viscosity), thus supporting the enhanced transition of liposomal vaccines from the bench to the clinic.

译文

脂质体作为肽,蛋白质和DNA疫苗的递送系统的优势已广为人知,不幸的是,它们的应用因其在储存过程中的不稳定性和有限的保质期而受到限制。此外,这些系统的灭菌一直存在问题,在使用各种可用技术灭菌后报道了脂质体的降解。工作形式我们的实验室已经研究了可应用于微粒脂质体疫苗的技术,以便可以冷冻干燥和无菌形式制备。在本文中,我们描述了脂质体疫苗的冻干,冷冻保护和灭菌技术。应用这些方法可以保留脂质的化学完整性和脂质体的关键理化特性 (例如粒径,ζ 电位和动态粘度),从而支持脂质体疫苗从实验室到临床的增强转变。

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