IN VITRO POTENCY ASSAY DEVELOPMENT FOR TETANUS ANTITOXIN

破伤风抗毒素体外效力测定的开发

• 批准号: 6101324
• 负责人: M C ANDERSON
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6101324
• 关键词: alternatives to animals in research; antibody titering; antitoxins; drug quality /standard; enzyme linked immunosorbent assay; guinea pigs; method development; tetanus toxin; tetanus toxoid

This study is designed to develop an in vitro potency assay to replace the guinea pig death test portion of official release test for the tetanus component in adsorbed toxoid vaccines. An ELISA method patterned after that reported in the literature, has been successfully adopted by the Laboratory of Standards and Testing. We continue to evaluate sera that has been tested in animals in the normal course of incoming product evaluation. The method of analysis has included statistical comparison between actual miciogram of tetanus antibody in different preparations and the determination of the relative potency of a pool of immunized animals to a quantitated reference. We are currently attempting to locate a source of purified toxin or toxoid suitable for the ELISA procedure that could be used in a collaborative study with other laboratories.

本研究旨在开发一种体外效价测定法，以取代 豚鼠死亡试验破伤风官方放行试验部分 吸附类毒素疫苗中的组分。 一种ELISA方法， 在文献中报道，已成功地通过了 标准和测试实验室。 我们继续评估血清， 已在正常的来料过程中进行了动物试验 评价 分析方法包括统计比较 不同制剂中破伤风抗体的实际微克数与 免疫动物池相对效价的测定 到定量参考。 我们目前正试图找到一个 适用于ELISA方法的纯化毒素或类毒素的来源， 可以与其他实验室进行合作研究。