The influence of the inactivating agent on the antigen content of inactivated Newcastle disease vaccines assessed by the in vitro potency test
The influence of the inactivating agent on the antigen content of inactivated Newcastle disease vaccines assessed by the in vitro potency test
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DOI：
10.1016/j.biologicals.2009.07.006
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发表时间：
2010-01-01
期刊：
影响因子：
1.7
通讯作者：
Schrier, C. C.
中科院分区：
文献类型：
--
作者：
Jagt, H. J. M.;Bekkers, M. L. E.;Schrier, C. C.
欧洲药典（EP）专著（01/2007.0870）最近纳入了一项体外效力试验，以评估新城疫（ND）灭活疫苗的效力。这种酶联免疫吸附试验（ELISA）是现有体内效价试验的一个有吸引力的替代方案，特别是考虑到欧洲当局取代、减少和改进实验动物用于免疫生物学产品的生产和质量控制的目标。在本研究中，失活剂对ELISA建立的抗原含量的影响进行了评估。因此，采用酶联免疫吸附试验（ELISA）对含有相似浓度的fl-丙内酯（BPL）或甲醛灭活新城疫病毒（NDV）的油基疫苗进行了检测，并对ep1中概述的体内效价进行了测试。结果表明，使用甲醛作为灭活剂比使用BPL作为灭活剂降低了体外效价。相比之下，体内效力不受影响。因此，ELISA不应用于比较含有甲醛灭活新城疫病毒的商业新城疫疫苗与含有BPL灭活新城疫病毒的新城疫疫苗的效力。然而，ELISA被认为是现有体内效力测试的一个有吸引力的替代方法，因为疫苗制造商可以使用它来释放新城疫灭活疫苗(C) 2009年国际生物制品协会出版，Elsevier Ltd.。版权所有
An in vitro potency test has recently been included in the European Pharmacopoeia (EP) monograph (01/2007.0870) to assess the potency of inactivated Newcastle disease (ND) vaccines. This enzyme linked immunosorbent assay (ELISA) is an attractive alternative for the existing in vivo potency tests especially with regard to the objective of the European Authorities to Replace, Reduce and Refine the use of laboratory animals for production and quality control of immunobiologicalsIn the present study the influence of the inactivant on the antigen content established by ELISA was evaluated. Therefore, oil based vaccines containing similar concentrations of fl-propiolactone (BPL) or formaldehyde inactivated Newcastle disease virus (NDV) were examined by ELISA and in the in vivo potency tests outlined in the EPThe results obtained demonstrate that the use of formaldehyde as inactivant lowered the in vitro potency compared to BPL as inactivant. In contrast, the in vivo potency was not affected. Therefore, the ELISA should not be used to compare the potency of commercial ND vaccines containing formaldehyde Inactivated NDV with those containing BPL inactivated NDV However, the ELISA is considered an attractive alternative for the existing in vivo potency tests since it can be used by vaccine manufacturers for the release of inactivated ND vaccines (C) 2009 The International Association for Biologicals Published by Elsevier Ltd. All rights reserved