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

Authors  Di Paolo A, Liberti R, Anzalone L, Colabella C, Felici A, Severi G, Cagiola M

Abstract  Background: Veterinary autogenous vaccines, similar to all injectable pharmaceutical products, must be tested to assess endotoxin concentrations. The Limulus Amebocyte Lysate Test (LAL test) is widely used in in vitro quality control assays for endotoxin detection, although it presents some ethical issues related to the production of reagents and is also characterized by a low specificity due to other contaminants that can activate the reaction. For all these reasons, a new recombinant factor C LAL test was developed. Aim: In this study, we described the comparison between two LAL test methods for in vitro quality control of veterinary autogenous vaccines, with the aim of evaluating the most suitable method and establishing an endotoxin concentration range for two different matrices. Methods: Two hundred batches of two different vaccine matrices were tested using the kinetic chromogenic LAL test and recombinant factor C endotoxin detection assay commercial kits. Results and conclusions: Statistical analysis conducted after the validation of the recombinant factor C test exhibited a statistically significant correlation between the two methods and for both vaccine matrices, suggesting that the animal-free assay can be used as a routine quality control test for veterinary autogenous vaccines.

Publish Date 2024

Volume 11 (12)

ISSN 2306-7381

DOI doi.org/10.3390/vetsci11120673

URL  https://www.mdpi.com/2306-7381/11/12/673

Journal   Veterinary Sciences

Pages art. n. 673

PMID 39729013