Leung T, Corran P H, Gee C, Ekong T A N, Sesardic D
National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK.
Dev Biol (Basel). 2002;111:327-32.
Tetanus vaccine is composed of chemically denatured tetanus toxin (TeNT), thus safety testing requires confirmation of freedom from residual and reversible toxicity. Currently, TeNT activity is estimated using in vivo assay models. Information that TeNT acts by selectively inactivating protein leading to the blocking of release of neurotransmitters has provided the opportunity to develop in vitro biochemical assay for toxin activity. In this study we describe development and use of an in vitro endopeptidase assay for detection of TeNT activity in toxoid vaccine formulations.
破伤风疫苗由化学变性的破伤风毒素(TeNT)组成,因此安全性测试需要确认无残留和可逆毒性。目前,TeNT活性是使用体内试验模型进行评估的。有信息表明TeNT通过选择性地使蛋白质失活从而导致神经递质释放受阻来发挥作用,这为开发毒素活性的体外生化检测方法提供了机会。在本研究中,我们描述了一种用于检测类毒素疫苗制剂中TeNT活性的体外内肽酶检测方法的开发和应用。