STABILITY OF TETANUS AND DIPHTHERIA TOXINS USING IMMUNOELECTROPHORESIS METHODS

标准品和参比品制备液的校准通常 任意分配;因为参考和标准是关键部分 该中心的释放和研究活动，一个计划， 表征这些化合物的化学和免疫学稳定性， 筹备工作仍在继续。 使用各种免疫学方法， 包括电泳、免疫印迹、ELISA、细胞测定和动物试验。 定期对试验、毒素和抗毒素进行定性检查， 数量上。 白喉毒素稳定性相关信息 已纳入白喉抗毒素的新测定方法。 这种新的测定方法，包括细胞存活测定，已被 用于检查毒素和抗毒素效力的保留。 当前甘油白喉和破伤风的年代测定 抗毒素标准已经扩展;冻干白喉 正在评估抗毒素。 根据收集到的信息， 采用制备方法制备对照品 破伤风毒素。 这种制剂T-3取代了旧的T-1对照品 在制造商和CBER测试发现新的毒素制剂后， 在产品发布测试中与T-1的反应类似。

Expiration dating for Standard and Reference preparations has often been assigned arbitrarily; since references and standards are a critical part of release and research activities of the Center, a program to characterize the chemical and immunological stability of these preparations is continuing. Using various immunological methods, including electrophoresis, immunoblotting, ELISA, cell assays and animal tests, toxins and antitoxins are periodically examined qualitatively and quantitatively. Information related to the stability of Diphtheria toxin has been incorporated into the new assay method for Diphtheria Antitoxin. This new assay method, consisting of a cell survival assay, has been employed to examine the retention of potency of both toxin and antitoxin. Expiration dating for current glycerinated Diphtheria and Tetanus antitoxin standards has been extended; a freeze-dried Diphtheria antitoxin is being evaluated. Based on collected information, a new preparation method was implemented for the preparation of Control Tetanus Toxin. This preparation, T-3, replaced the old T-1 control after manufacturers and CBER testing found the new toxin preparation to respond similarly to T-1 in product release testing.