Chemical components analysis and morphology observation of virus in Japanese encephalitis vaccine produced from Beijing strain

ABSTRACT

The first 5 lots of Japanese encephalitis vaccines produced from Beijing-1 strain JB011203, JB021203, JB030104, JB040204 and JB050304 were controlled of quality on chemical components and virus morphology in vaccine, using reference vaccine EJP034A (BIKEN-Japan). The results showed that TCA-protein was 13.2- 14.5 µg/ml, the reference was 11.1 µg/ml (WHO standard 5-40 µg/ml). The thimerosal content was 82-84 µg/ml, the reference 76,3 µg/ml (WHO standard ≤120 µg/ml). The formaldehyde content was 0.061-0.063 µg/ml, the reference was 2.19 µg/ml (WHO standard ≤100 µg/ml). pH was 7.02-7.04, the reference was 7.10 (WHO stand. 6.8-7.4). The viruses morphology after negative stain were observed on electromicroscope JEM1010 with enlarge x 90.000 and x 150.000. The identical ball form of purified viruses with the intact surface antigen. 5/5 lots were passed the minimum requirements of biological products of WHO.