Object ive To investigate the stability of bulk and final product of recombinant hepatitis B(HB)vaccine containing PreS antigen prepared with Pichia pastoris.Methods Three batches of bulk were stored at 4 ℃,from which samples were taken 0,1,2,3 and 6 months after storage and determined for titers of HBsAg(S),PreS1 and PreS2 as well as the HPLC purity.Three consecutive batches of final products were stored at 25 and 4 ℃ for accelerated and long-term stability tests respectively.Samples were taken from the fi...
【更新日期】
2012-10-24
【分类号】
R373.21
【正文快照】
乙型肝炎(简称乙肝)疫苗已大规模使用愈20年,但乙型肝炎病毒(Hepatitis B virus,HBV)感染仍是最为严重的全球性健康问题之一。据世界卫生组织报道,全球现有约3.6亿慢性HBV携带者,每年约有60万人死于HBV感染引起的肝衰竭、肝硬化和肝细胞癌[1]。接种乙肝疫苗是预防和控制HBV传播
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