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Establishment of the 3rd national standard for lot release testing of the Japanese encephalitis vaccine (Nakayama-NIH strain) in Korea
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 vaccin...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Taylor & Francis
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4964809/ https://www.ncbi.nlm.nih.gov/pubmed/26890572 http://dx.doi.org/10.1080/21645515.2016.1143994 |
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author | Lee, Sunmi Moon, Hyungsil Kim, Min Gyu Kim, Do Keun Chung, Hye Joo Park, Yong Keun Oh, Ho Jung |
author_facet | Lee, Sunmi Moon, Hyungsil Kim, Min Gyu Kim, Do Keun Chung, Hye Joo Park, Yong Keun Oh, Ho Jung |
author_sort | Lee, Sunmi |
collection | PubMed |
description | 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 (log(10)) per vial. Therefore, the newly established national standard material is expected to be used for the Japanese encephalitis vaccine lot release in Korea. |
format | Online Article Text |
id | pubmed-4964809 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Taylor & Francis |
record_format | MEDLINE/PubMed |
spelling | pubmed-49648092016-08-12 Establishment of the 3rd national standard for lot release testing of the Japanese encephalitis vaccine (Nakayama-NIH strain) in Korea Lee, Sunmi Moon, Hyungsil Kim, Min Gyu Kim, Do Keun Chung, Hye Joo Park, Yong Keun Oh, Ho Jung Hum Vaccin Immunother Commentary 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 (log(10)) per vial. Therefore, the newly established national standard material is expected to be used for the Japanese encephalitis vaccine lot release in Korea. Taylor & Francis 2016-02-18 /pmc/articles/PMC4964809/ /pubmed/26890572 http://dx.doi.org/10.1080/21645515.2016.1143994 Text en © 2016 The Author(s). Published with license by Taylor & Francis Group, LLC http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted. |
spellingShingle | Commentary Lee, Sunmi Moon, Hyungsil Kim, Min Gyu Kim, Do Keun Chung, Hye Joo Park, Yong Keun Oh, Ho Jung Establishment of the 3rd national standard for lot release testing of the Japanese encephalitis vaccine (Nakayama-NIH strain) in Korea |
title | Establishment of the 3rd national standard for lot release testing of the Japanese encephalitis vaccine (Nakayama-NIH strain) in Korea |
title_full | Establishment of the 3rd national standard for lot release testing of the Japanese encephalitis vaccine (Nakayama-NIH strain) in Korea |
title_fullStr | Establishment of the 3rd national standard for lot release testing of the Japanese encephalitis vaccine (Nakayama-NIH strain) in Korea |
title_full_unstemmed | Establishment of the 3rd national standard for lot release testing of the Japanese encephalitis vaccine (Nakayama-NIH strain) in Korea |
title_short | Establishment of the 3rd national standard for lot release testing of the Japanese encephalitis vaccine (Nakayama-NIH strain) in Korea |
title_sort | establishment of the 3rd national standard for lot release testing of the japanese encephalitis vaccine (nakayama-nih strain) in korea |
topic | Commentary |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4964809/ https://www.ncbi.nlm.nih.gov/pubmed/26890572 http://dx.doi.org/10.1080/21645515.2016.1143994 |
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