Anti-Tumor Effect of Newcastle Disease Virus Vaccine for Human Use Preparation Process

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 in 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-quality 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 hemagglutination 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.