Department of Biotechnology, Israel Institute for Biological Research, Ness Ziona, Israel.
Cell Culture Research Unit, Department of Biotechnology, Israel Institute for Biological Research, Ness Ziona, Israel.
Vaccine. 2017 Dec 19;35(52):7213-7216. doi: 10.1016/j.vaccine.2017.11.015. Epub 2017 Nov 22.
Botulism therapy relies on passive immunization with antitoxin. The mouse neutralization test is the only pharmacopeia assay to measure the potency of antitoxin preparations. Herein, we present an in vitro cell-based assay for the measurement of pharmaceutical type A antitoxin potency. Accuracy, reproducibility and compatibility with the mouse bioassay were demonstrated using different batches of standard antitoxin and toxin preparations. The established assay may substantially reduce the use of laboratory animals in the process of pharmaceutical antitoxin production.
肉毒中毒的治疗依赖于抗毒素的被动免疫。小鼠中和试验是唯一的药典测定法，用于测量抗毒素制剂的效价。本文介绍了一种基于细胞的体外测定法，用于测量A型药用抗毒素的效价。使用不同批次的标准抗毒素和毒素制剂证明了该测定法的准确性、重现性和与小鼠生物测定法的兼容性。该建立的测定法可大大减少在药物抗毒素生产过程中对实验动物的使用。
