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Vaccines-2013 - OMICS Group

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Byung Chul Kim et al., J <strong>Vaccines</strong> Vaccin <strong>2013</strong>, 4:5http://dx.doi.org/10.4172/2157-7560.S1.0173 rd International Conference on<strong>Vaccines</strong> & VaccinationJuly 29-31, <strong>2013</strong> Embassy Suites Las Vegas, NV, USAEstablishment of the 3 rd national standard for in vitro potency assay of Japanese encephalitisvirus vaccineByung Chul Kim, Hyung-sil Moon, DoKeun Kim, Tae Moo Yoo, Sung Hwa Hong, Naery Lee, Jong-Mi Lim, Donghee Kim, Seokkee Chang,Jiyoung Hong, Jooyeon Lee and Ho Jung OhNational Institute of Food and Drug Safety Evaluation, KoreaTraditionally, the quality control for Japanese Encephalitis Virus (JEV) vaccine has performed in vivo potency assay usinganimals. The Ministry of Food and Drug Safety (MFDS) established alternative in vitro assay (ELISA) replacing the in vivoassay requiring animals and many times as an official quality control method of potency test for the JEV vaccine. The in vitropotency assay showed it's faster and easy to perform without pre-treatment such as a mouse immunization. Also it had betterprecision and reproducibility comparing to the conventional in vivo assay.The reference material is essential in order to evaluate potency test for the JEV vaccine. The 1 st and 2 nd national standardfor in vivo potency assay of JEV vaccine had manufactured, each established in 2001 and 2007, and have been using for themanufacturer's quality control and national lot release since then. As the need of the national standard for in vitro potency assay,this study was initiated by MFDS in <strong>2013</strong> to manufacture and establish the 3 rd national standard for in vitro and in vivo potencyassay of JEV vaccine. The in vitro and in vivo potency results of the candidate material for 3 rd national standard, each weremeasured 1.077 and 2.761. In the study hereafter, the collaborative study of the MFDS and manufacturers will be conducted toestimate the reliable virus content with the candidate material.happysea@korea.krJ <strong>Vaccines</strong> Vaccin <strong>2013</strong>ISSN: 2157-7560, JVV an open access journal<strong>Vaccines</strong>-<strong>2013</strong>July 29-31, <strong>2013</strong>Volume 4 Issue 5Page 111

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