Journal of Vaccines & Vaccination

Study for manufacture and establishment of 1st national standard material for cell derived Japanese encephalitis vaccine (Beijing strain)

10^th Euro Global Summit and Expo on Vaccines & Vaccination

June 16-18, 2016 Rome, Italy

Ji Young Hong, Sangil Choi, Nea Ri Lee, Dong Hee Kim, Sun Mi Lee, Jihye Jung, Seokkee Chang, Yejin Choi, Sunbo Shim, Ho Jung Oh and Hye Joo Chung

National Institute of Food and Drug Safety Evaluation, Korea

Posters & Accepted Abstracts: J Vaccines Vaccin

Abstract:

Japanese encephalitis virus (JEV) is a mosquito born Flavivirus that causes public health problems in Asian countries. Until quite recently, the primary JE vaccine in use internationally has been the mouse brains JE vaccine, which is now commonly replaced by cell culture based vaccines. The Vero cell derived JEV have been licensed for routine use in Korea, 2013. Also Vero cell derived JE vaccines has been included in the national immunization program since 2015. In Korea, every vaccine lot is tested through National lot release. Because of biological products, kinds of viral vaccine composed of materials complexity. It is very difficult to identify by physical or chemical method. Therefore, the reference standard is indispensable for the consistent potency management of viral vaccine. The purpose of this study is to prepare candidate of the 1st national standard material for Vero cell derived JE vaccines and verify the quality with long term and accelerated stability test. The candidate was manufactured in GMP facility and virus content test, appearance, moisture content, particulate contamination, weight variation, sterility, abnormal toxicity, identification were performed to evaluate the quality as well as the accelerated stability and long-term stability. Through the quality test with long term and accelerated stability could verify quality of candidate of the 1st national standard material for Vero cell derived JE vaccines. It recommends to collaborative study for potency test and we are going to monitor long term stability to verify the quality of the 1st national standard material for Vero cell derived JE vaccines.

Biography :

Ji Young Hong has completed her Master’s degree from Korea University majored in Molecular Biology. She has worked in the Division of Enteric & hepatitis virus, National Institute of Health for about 5 years. Currently she is working on Vaccines Division, National Institute of Food & Drug Safety Evaluation since 2009.

Email: ecadee81@korea.kr