Biologicals ( IF 1.7 ) Pub Date : 2019-10-20 , DOI: 10.1016/j.biologicals.2019.10.005 Suresh Beri 1 , Darshan Gandhi 1 , Neil Ravenscroft 2
The native structure of the bacterial polysaccharide is the key immunogenic component of conjugate vaccines and antibodies raised against the polysaccharide structure are responsible for providing protection against the corresponding pathogen. The manufacturing process of conjugate vaccines is very complex and has various biological and chemical steps. It is important to monitor the process to ensure that the structural identity of the polysaccharide is maintained throughout the process. NMR spectroscopy can be used as a versatile analytical tool to monitor the structural integrity of the polysaccharide component from isolated polysaccharide to conjugate vaccine and for identifying different impurities generated during the process.
中文翻译:
在开发针对b型流感嗜血杆菌(Hib)和A型脑膜炎球菌血清群(MenA)的结合疫苗的过程中,使用NMR作为分析工具。
细菌多糖的天然结构是偶联疫苗的关键免疫原性成分,针对多糖结构的抗体负责提供针对相应病原体的保护。结合疫苗的制造过程非常复杂,并且具有各种生物学和化学步骤。监测过程以确保在整个过程中保持多糖的结构同一性很重要。NMR光谱可以用作一种通用的分析工具,以监测从分离的多糖到结合疫苗的多糖组分的结构完整性,并鉴定过程中产生的不同杂质。