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bexsero（脑膜炎球菌组B疫苗）可注射的悬浮液，用于肌内使用
NADA成分是源自脑膜炎N. n. n. s. n. s. n. n. n. n. n. n. n. s.NHBA成分分别由NHBA（肽2）1和辅助蛋白953组成的重组融合蛋白分别衍生自脑膜炎N.脑膜炎菌株NZ98/254和2996。FHBP成分是由FHBP（变体1.1）1和辅助蛋白936组成的重组融合蛋白，分别衍生自Meningitis菌株MC58和2996。这3种重组蛋白是在大肠杆菌中单独产生的，并通过一系列柱色谱步骤纯化。OMV抗原成分是通过发酵脑膜炎菌株NZ98/254（表达外膜蛋白porin a [pora] Serosubtype p1.4）2，然后被脱氧乙酸酯灭活的细菌，这也介导了牛乳酪组成。抗原被吸附到氢氧化铝上。
BEXSERO (Meningococcal Group B Vaccine) injectable suspension, for intramuscular use
The NadA component is a fragment of the full-length protein derived from N. meningitidis strain 2996 (peptide 8 variant 2/3) 1 . The NHBA component is a recombinant fusion protein comprised of NHBA (peptide 2) 1 and accessory protein 953 derived from N. meningitidis strains NZ98/254 and 2996, respectively. The fHbp component is a recombinant fusion protein comprised of fHbp (variant 1.1) 1 and the accessory protein 936 derived from N. meningitidis strains MC58 and 2996, respectively. These 3 recombinant proteins are individually produced in Escherichia coli and purified through a series of column chromatography steps. The OMV antigenic component is produced by fermentation of N. meningitidis strain NZ98/254 (expressing outer membrane protein Porin A [PorA] serosubtype P1.4) 2 , followed by inactivation of the bacteria by deoxycholate, which also mediates vesicle formation. The antigens are adsorbed onto aluminum hydroxide.
EDA生物药产品评估报告
其作用方式和适应症： - Bexsero是预注射器（PFS）注射的悬架，并包含三种重组蛋白（RP），外膜外囊泡（OMV）和摄取剂（氯化钠，氯化钠，组氨酸，氧化氧，氧化铝，羟基氧化铝和水的水）。- bexsero包含4种不同的活性成分，外膜外囊泡（OMV），这些成分是从奈瑟氏菌（N. meningitidis）血清的细菌膜中提取的，它们是B菌群B菌株NZ98/254和三个N.脑膜炎细胞表面抗原；蛋白质961c，蛋白质287-953，蛋白936-741，由重组DNA技术在大肠杆菌中生产。- 该药物被吸附在氢氧化铝（AL（OH）3）上，作为注射悬浮液。Bexsero中的Al（OH）3浓度为1.5 mg/剂量，对应于每疫苗剂量0.5 mg的元素铝。- bexsero指示针对由2个月及以上的个体中脑膜炎血清群B菌株引起的浸润性疾病的主动免疫。