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C群脑膜炎球菌多糖和结合疫苗通过物理化学方法进行了初步评价,以期确保每批制品被恒定地制备出来。由于使用了不同的检测方法定量测定原液以及半成品的多糖含量,因此有必要建立一种MenC PS国际标准,以作为标准参考制剂用于不同实验室校准之用。分布于9个不同国家的12个实验室参与了这项国际性研究,以期测定候选国际标准MenC PS制剂(08/214)的MenC PS含量并且评估它的适用性。在这项研究结果基础上,人们将候
The meningococcal group C meningococcal polysaccharide and conjugate vaccine were initially evaluated by physicochemical methods to ensure that each batch of product was consistently prepared. Due to the different detection methods used to quantify the polysaccharide content of stock and semi-finished products, it is necessary to establish a MenC PS international standard for use as a standard reference preparation for different laboratory calibrations. Twelve laboratories in nine different countries participated in this international study to determine the MenC PS content of the candidate international standard MenC PS preparation (08/214) and assess its suitability. Based on the results of this study, people will wait