鸡胚成纤维细胞培养抗肿瘤NDV疫苗的实验研究

目的用细胞培养法研制高效价人用抗肿瘤NDV。方法采用鸡胚成纤维细胞低血清培养法,在接种NDV之前的细胞培养中,少量使用优质小牛血清（2%）,让单层细胞基本铺满培养瓶底时,用无血清培养液多次洗涤单层细胞,以尽量降低残余牛血清含量。接种NDV之后,以人白蛋白代替小牛血清继续滋养细胞,培养病毒。结果NDV收获液LogPFU≥5.5,血凝效价1：640,经反向间接血凝试验检测,残余牛血清蛋白含量≤50ng/ml。结论NDV效价和活性符合人用疫苗要求。

Preparation of NDV Anti-tumor Vaccine for Human Use

Objective This project focuses on the improvement of NDV production technology and innovation of the NDV vaccine preparation process with cell culture technology. Methods To use primary chick embryo cell culture system m preparation of NDV anti-tumor vaccine. Results In the new vaccine development process, the focused on maintaining and improving NDV titer while reducing the residual bovine serum. So that the new vaccine achieve the requirements of national＇s human biological products standards. 1. Using a small number of high-quailty calf serum （2%） before addition of NDV to the cells and washing single cell layer with serum-free medium after the confluence of the cell to reduce the content calf serum. 2. Replacing calf serum to human albumin in addition of NDV. The residual of bovine serum protein contents is lower than 50 ng/ml （reverse indirect hamagglutination assay） after using of these methods. NDV Outcome culture fluid Log PFU≥ 5. 5, hemagglutinin titer 1： 640. Conclusions The potency and activity of NDV have reached the quality requirements of biological products in China.