Scientific Officer, Vaccines Division, Ministry of Food and Drug Safety, Republic of Korea

Sunmi Lee has been working for thirteen years in Korean National Institute of Food and Drug Safety Evaluation as a scientific officer. Her career at the NIFDS began from 2009, as a reviewer for cell therapeutic medicinal products. She is now working in Vaccines Division which is in charge of the national lot-release and research projects for preventive vaccine products. She actively continues her research work for bacterial vaccines including BCG and Typhoid vaccines following the viral vaccines like Influenza and Japanese encephalitis vaccines. She finished her Ph.D. in the bio-regulatory sciences at Korea University, 2019. She previously studied various research themes related to the redox signaling during her short dispatch work in the U.S. National Institute of Health.

Speech Title: Establishment of National Standard and Specification for Japanese Encephalitis Vaccine Quality Control

Abstract: Japanese encephalitis vaccine is one of the preventive vaccines listed in National Immunization Program in Korea. In order to conduct the routine quality control such as the potency test, it is necessary to establish a reliable reference standard assuring the robustness of the analytical method and improving the precision of the test result. In Korea, the 2nd national standard which was established in 2007 is currently used for Japanese encephalitis vaccine (Nakayama-NIH strain) potency test. However, the supply of the 2nd national standard was anticipated to be exhausted by 2015, necessitating the supply of a new national reference standard with quality equivalent to the existing standard. A collaborative study was carried out to assign the in vivo and in vitro potencies against the new standard candidate material. The in vivo potency of the 3rd national standard was determined to be 2.69 neutralizing-antibody titer (log10) per vial according to the in vivo test method listed in Minimum Requirement for Biological Products. Using the enzyme-linked immunosorbent assay which was validated in the previous study, the in vitro relative potency of the 3rd national standard was set to be as 0.97 relative to the 2nd national standard. Due to the initiatives of the study planning to introduce the in vitro test method into the vaccine manufacturers, we conducted the additional collaborative study to establish the criteria for the in vitro potency test against two Japanese encephalitis vaccine products manufactured in Korea. The test criteria were newly determined to be 2.04 ~ 4.39 E-antigen units per vial for the Product I and 2.99 ~ 6.01 E-antigen units per vial for the Product II, respectively, using 20 lots for each product. The integrated specification of 40 lots was set to be as 1.50 ~ 6.22 E-antigen units per vial.

Keywords: Japanese encephalitis vaccine, Korean 3rd national standard, Potency assay