猪支原体肺炎疫苗效力检验常见问题与质量控制

General Issues and Quality Control of Potency Testof Mycoplasma Hyopneumoniae Vaccines

关键词:  猪支原体肺炎疫苗  效力检验  替代方法

Key words:  Mycoplasma hyopneumoniae vaccines  Potency test  Alternative methods.

摘要:

为了更规范、标准地评价猪支原体肺炎疫苗,本研究对近年来猪支原体肺炎疫苗检验进行了系统性分析。结果发现,效力检验作为疫苗质量的核心内容,是检验中最易出现问题参数。对效力检验相关方法、常见问题进行分析,有助于企业在研发过程中规避问题,提高疫苗质量继而保障养殖业发展。

Abstract:

In order to evaluate Mycoplasma hyopneumoniae vaccines in a more consistent and standard way, this study systematically analyzed the testing of Mycoplasma hyopneumoniae vaccines in recent years. It was found that potency test, as the core component of vaccine quality, is the most problematic parameter in the test. The analysis of the methods and general issues related to potency test can help veterinary biologics enterprises avoid problems in the development process and improve vaccine quality to finally safeguard the farming industry.