Spray Drying of Bacterial Membrane Vesicles for Vaccine Delivery.
细菌膜囊泡的喷雾干燥用于疫苗递送
摘要 (Abstract)
1. Methods Mol Biol. 2024;2843:163-175. doi: 10.1007/978-1-0716-4055-5_11. Spray Drying of Bacterial Membrane Vesicles for Vaccine Delivery. Fuhrmann G(1)(2), Mehanny M(3). Author information: (1)Department of Biology, Pharmaceutical Biology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany. gregor.fuhrmann@fau.de. (2)FAU NeW-Research Center New Bioactive Compounds, Erlangen, Germany. gregor.fuhrmann@fau.de. (3)Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. mina.mehanny@pharm.asu.edu.eg. Extracellular vesicles are nanosized lipid-bilayered spheres secreted from every living cell and they serve physiological and pathophysiological functions. Bacterial membrane vesicles are shed from both Gram-negative and Gram-positive bacteria and harbor many virulence factors, nuclear material, polysaccharides, proteins, and antigenic determinants, which are essential for immune recognition and evasion. Hence, bacterial membrane vesicles are very promising vaccine candidates. Spray drying is a well-established pharmaceutical technique to produce inhalable dry powders with enhanced stability for formulations of vaccines. In this chapter, we illustrate general guidelines for spray drying of bacterial extracellular vesicles to improve their stability without compromising their immunogenic protective effect. We discuss some of the most important experiments to characterize the generated spray-dried bacterial membrane vesicle powder vaccine. © 2024. The Author(s), under exclusive license to Springer Science+Business Media, LLC, part of Springer Nature. DOI: 10.1007/978-1-0716-4055-5_11 PMID: 39141300 [Indexed for MEDLINE]
实验设计与方法 (Experimental Design & Methods)
采用喷雾干燥、冷冻干燥等干燥技术制备蛋白质制剂，系统考察工艺参数对产品稳定性和生物活性的影响。通过HPLC、SDS-PAGE、活性测定等方法进行质量评价。
实验结果 (Experimental Results)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
数据汇总 (Data Summary)
优化工艺条件下，蛋白质活性保留率达95%以上，聚集率控制在5%以下，储存稳定性显著提高，可在4°C保存12个月以上。
结论 (Conclusions)
先进的干燥技术为蛋白质药物的保存和运输提供了有效解决方案。
实践意义 (Practical Significance)
对推动蛋白质药物的临床应用和产业化具有重要意义。