Study of the stability of the reconstituted vaccine against contagious bovine lumpy skin disease manufactured by the central veterinary Laboratory of Bamako (Mali)

The present study carried out at the Central Veterinary Laboratory of Mali (LCV) aimed to determine the stability of the DERMAPOX vaccine after its reconstitution. It focused on (03) pilot batches of vaccine against Contagious Bovine Lumpy Skin Disease (LSD) codenamed DERMAPOX. Batches of DERMAPOX Nos. Pox 001, Pox 002 and Pox 003 produced according to Good Manufacturing Practices. The production and quality control procedures of culture media, semi-finished and finished product solutions did in accordance with the production protocol and the vaccine quality control manual of the LCV in accordance with the vaccine quality control manual of the Pan African Vaccine Quality Control Center (PANVAC) and the European Pharmacopoeia monographs. Said batches of DERMAPOX N° Pox 001, N° Pox 002 and N° Pox 003 products have obtained the good quality label. The results of the quality control of the vaccine lyophilisate reconstituted with sterile physiological water were found to comply with the required sterility and titration specifications. The evaluation of the titer of the viral antigen, the standard of which is ≥102.5DICT50 per vaccine dose, made it possible to determine an average no loss or no degradation) of 0.09 log 10 ± 0.05 defining a limit of viability of use of five (05) hours after reconstitution of DERMAPOX.