采用鲎试剂法首次对意大利生产的兽用自体疫苗中的内毒素进行评估。

First evaluation of endotoxins in veterinary autogenous vaccines produced in Italy by LAL assay.

作者信息

Di Paolo Antonella, Forti Katia, Anzalone Lucia, Corneli Sara, Pellegrini Martina, Severi Giulio, Cagiola Monica

机构信息

Istituto Zooprofilattico Sperimentale dell'Umbria e delle Marche "Togo Rosati" Pharmaceutical Unit, Via G. Salvemini 1, 06126, Perugia (PG), Italy.

出版信息

Biologicals. 2018 Sep;55:71-73. doi: 10.1016/j.biologicals.2018.06.001. Epub 2018 Jun 21.

DOI:10.1016/j.biologicals.2018.06.001

PMID:29935930

Abstract

Endotoxin contamination is a serious concern for manufacturers of biological products and vaccines in terms of not only quality but also safety parameters. We evaluated the endotoxin presence in different veterinary autogenous vaccines produced by the Pharmaceutical Unit at the Experimental Zooprophylactic Institute of Umbria and Marche "Togo Rosati" (IZSUM). According to the 3Rs principles (Replace, Reduce, Refine), which aim to progressively reduce animal use in the quality control process, we tested the vaccines obtained from gram-negative bacteria and adjuvants by the limulus amebocyte lysate (LAL) assay. The results revealed low endotoxin concentrations compared to available data in the literature and represent the first report of the application of the 3Rs principles to veterinary autogenous vaccines production in Italy.

摘要

内毒素污染不仅在质量方面，而且在安全参数方面都是生物制品和疫苗制造商严重关切的问题。我们评估了由翁布里亚和马尔凯大区“托戈·罗萨蒂”实验动物卫生研究所（IZSUM）制药部门生产的不同兽用自体疫苗中的内毒素存在情况。根据旨在逐步减少质量控制过程中动物使用的3R原则（替代、减少、优化），我们通过鲎试剂法（LAL）检测了从革兰氏阴性菌和佐剂中获得的疫苗。与文献中的现有数据相比，结果显示内毒素浓度较低，并且这是3R原则在意大利兽用自体疫苗生产中的首次应用报告。