title: Establishment of the 3rd national standard for lot release testing of the Japanese encephalitis vaccine (Nakayama-NIH strain) in Korea.
abstract: In Korea, 2 inactivated Japanese encephalitis vaccines from Nakayama-NIH and Beijing-1 strain have been utilized to date. The 1(st) national standard for lot release testing of the JE vaccine was established in 2002. The 2(nd) national standard, established in 2007, is currently in use for JE vaccine (Nakayama-NIH strain) potency testing. However, the supply of this standard is expected to be exhausted by 2015, necessitating the establishment of a new national standard with quality equivalent to that of the existing standard. Quality control tests were performed to verify that the new standard candidate material was equivalent to that of the 2(nd) national standard, proving its appropriateness for potency testing of JE vaccine. In addition, based on the results of a collaborative study conducted among 4 institutions including Ministry of Food and Drug Safety, the potency of the new national standard material was determined to be 2.69 neutralizing-antibody titer (log10) per vial. Therefore, the newly established national standard material is expected to be used for the Japanese encephalitis vaccine lot release in Korea.
authors.affiliation: a National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety , Cheongju-si , Republic of Korea.|c School of Life Sciences and Biotechnology, Korea University , Seoul , Republic of Korea.
authors.forename: Sunmi
authors.initials: S
authors.lastname: Lee
authors.affiliation: b Daejeon Regional Office of Ministry of Food and Drug Safety , Daejeon , Republic of Korea.
authors.forename: Hyungsil
authors.initials: H
authors.lastname: Moon
authors.affiliation: a National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety , Cheongju-si , Republic of Korea.
authors.forename: Min Gyu
authors.initials: MG
authors.lastname: Kim
authors.affiliation: a National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety , Cheongju-si , Republic of Korea.
authors.forename: Do Keun
authors.initials: do K
authors.lastname: Kim
authors.affiliation: a National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety , Cheongju-si , Republic of Korea.
authors.forename: Hye Joo
authors.initials: HJ
authors.lastname: Chung
authors.affiliation: c School of Life Sciences and Biotechnology, Korea University , Seoul , Republic of Korea.
authors.forename: Yong Keun
authors.initials: YK
authors.lastname: Park
authors.affiliation: a National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety , Cheongju-si , Republic of Korea.
authors.forename: Ho Jung
authors.initials: HJ
authors.lastname: Oh
mesh_terms: D004672:Encephalitis, Japanese / Q000517:prevention & control*; D006801:Humans; D022321:Japanese Encephalitis Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000592:standards*; D007723:Korea; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods*; D064166:Vaccine Potency
chemical_list: D022321:Japanese Encephalitis Vaccines
keywords: japanese encephalitis (JE) vaccine; korean national standard; lot release testing; plaque reduction neutralization assay; potency assay