STABILITY OF TETANUS AND DIPHTHERIA TOXINS USING IMMUNOELECTROPHORESIS METHODS

标准制剂和参比制剂的有效期通常是 任意分配；因为参考和标准是关键部分 该中心的发布和研究活动，一个计划，以 表征这些化合物的化学和免疫稳定性 准备工作仍在继续。利用各种免疫学方法， 包括电泳法、免疫印迹法、酶联免疫吸附试验、细胞测定法和动物实验 定期对测试、毒素和抗毒素进行定性检查和 从数量上讲。与白喉毒素稳定性有关的信息 已被纳入新的白喉抗毒素检测方法。 这种新的检测方法，由细胞存活检测组成，已经被 用来检测毒素和抗毒素的效力的保留性。 当前甘油白喉和破伤风的有效期 抗毒素标准已经延长；一种冷冻干燥的白喉 抗毒素药物正在评估中。根据收集到的信息，一项新的 对照制剂实施制备法 破伤风毒素。这种制剂，T-3，取代了旧的T-1对照 在制造商和CBER测试发现新的毒素制剂 在产品发布测试中对T-1做出类似的响应。

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.