丹毒灭活疫苗体外效价测定的探讨。

Developments in biologicals Pub Date : 2012-01-01
E Balks, C Wolf, H Loessner, E Werner
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引用次数: 0

摘要

博士欧元。专论0064“猪丹毒疫苗(灭活)”目前建议进行批量效价检测的小鼠血清学。然而,疫苗生产的技术进步、质量控制系统的改进和全面的上市后监测日益促进对非动物方法进行批量放行试验的接受。利用SDS-PAGE和Western Blot技术获得猪丹毒灭活疫苗的蛋白质和免疫图谱,可能为猪丹毒灭活疫苗提供一种方便的、全球性的、功能性的体外替代方法。可以获得铝佐剂疫苗的特征和一致的蛋白质和免疫谱。小鼠多克隆血清的免疫反应性与猪血清的免疫反应性明显不同。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Towards in vitro potency testing of inactivated erysipelas vaccines.

Ph. Eur. Monograph 0064 "Swine erysipelas vaccine (inactivated)" currently advises mouse serology for batch potency testing. However, technological advances in vaccine production, improved quality control systems and comprehensive post marketing surveillance increasingly promote the acceptance of non-animal approaches for batch release testing. Protein and immune profiles of inactivated swine erysipelas vaccines obtained by SDS-PAGE and Western Blot might offer a convenient global and functional in vitro alternative. Characteristic and consistent protein and immune profiles could be obtained for aluminium-adjuvanted vaccines. Immunoreactivity of polyclonal sera raised in mice differs markedly from reactivity of swine sera.

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