First evaluation of endotoxins in veterinary autogenous vaccines produced in Italy by LAL assay. 2018

Antonella Di Paolo, and Katia Forti, and Lucia Anzalone, and Sara Corneli, and Martina Pellegrini, and Giulio Severi, and Monica Cagiola
Istituto Zooprofilattico Sperimentale dell'Umbria e delle Marche "Togo Rosati" Pharmaceutical Unit, Via G. Salvemini 1, 06126, Perugia (PG), Italy.

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.

UI MeSH Term Description Entries
D007558 Italy A country in southern Europe, a peninsula extending into the central Mediterranean Sea, northeast of Tunisia. The capital is Rome. Sardinia
D008033 Limulus Test Sensitive method for detection of bacterial endotoxins and endotoxin-like substances that depends on the in vitro gelation of Limulus amebocyte lysate (LAL), prepared from the circulating blood (amebocytes) of the horseshoe crab, by the endotoxin or related compound. Used for detection of endotoxin in body fluids and parenteral pharmaceuticals. Limulus Tests,Test, Limulus,Tests, Limulus
D004731 Endotoxins Toxins closely associated with the living cytoplasm or cell wall of certain microorganisms, which do not readily diffuse into the culture medium, but are released upon lysis of the cells. Endotoxin
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D000820 Animal Diseases Diseases that occur in VERTEBRATE animals. Diseases, Animal
D054991 Autovaccines Bacterial vaccines prepared from non-pathogenic, autologous bacteria of human origin. In Eastern Europe they are used in humans to treat chronic inflammatory disorders that are resistant to standard treatments. Worldwide they have veterinary use in all types of infectious disease. Autogenous Vaccine,Autogenous Vaccines,Autovaccine,Vaccine, Autogenous,Vaccines, Autogenous

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