Istituto Zooprofilattico Sperimentale dell'Umbria e delle Marche ''Togo Rosati''

Authors  Di Paolo A, Forti K, Anzalone L, Pellegrini M, Corneli S, Canonico G, Severi G, Cagiola M

Abstract  Endotoxins are high molecular weight complexes associated with Gram-negative bacteria; they are the most significant source of pyrogens in pharmaceutical water, raw materials, parenteral products, and medical devices. It is a real concern for regulatory agencies, manufacturers, and healthcare professional, thus the low amount or no presence of endotoxins is one of the most important goals. In fact, high levels of endotoxin can rise to a range of pathophysiological reactions and adverse effects following vaccination, as observed in in human and animals. A recommended endotoxin limit <200 EU/mL for live attenuated human vaccines comes from the complex nature of multi-antigen vaccines, indeed limit <500 EU/mL is recommended for inactivated human vaccines (Brito e Singh, 2011). On the strong hint of the 63/2010 EU Directive (Direttiva 2010/63/EU), which was transposed to Italy in 2014, Experimental Zooprophylactic Institute of Umbria and Marche (IZSUM) carried out an initial evaluation of vaccines produced at UODOF with new in vitro methods, where possible, alternative to the use of animals for quality test in pharmacological, cosmetic and research applications.

Publish Date 2018

Volume  107

ISSN 1592-1581

DOI  no

URL  https://www.spvet.it/archivio/numero-107/678.html

Journal  Sanità Pubblica Veterinaria

Pages  No

PMID  No