Efficacy of an inactivated and adjuvanted “ZULVAC®8 OVIS” vaccine produced using single-use bioreactors

Abstract

Bluetongue virus (BTV) first emerged in the European Union (EU) in 2006, peaking at 45,000 cases in 2008. The EU spent million of euros in 2008 and 2009 on eradicating and monitoring programs, co-financed with member states. The number of cases in 2009 was 1118, with only 120 reported across the EU so far last year. Vaccination has proven itself as the most effective tool to control and prevent the disease and to facilitate the safe trade of live animals. Mammalian cells are commonly used as a substrate for production of most of the viral vaccines. BHK-21 cells are used for the production of bluetongue vaccines. Most companies use roller bottles or conventional bioreactors, but taking into account that the manufacturing cost is very important, the possibility of using Single-Use Bioreactor (SUB) technology as an alternative to roller bottles or conventional bioreactors was explored. Advantages like yields of production, time reduction (elimination of cleaning and sterilization steps needed for bioreactors, no validation process, etc) and quality of antigen production were studied.