VALIDATION OF POTENCY TEST OF NEW GENERATION JAPANESE ENCEPHALITIS VACCINE IMOJEV BY PLAQUE FORMING UNIT (PFU) METHOD

Abstract

Implementation of potency test for new generation Japanese Encephalitis vaccine (IMOJEV) is one of the functions of National Institute for Vaccines and Biologicals (NICVB) prior to market release. Potency test of IMOJEV was carried out by using Plaque Forming Unit (PFU) method for both standard and testing samples, the results was in the approved range of manufacturer. The process of validation of potency test for Japanese Encephalitis vaccine IMOJEV was built and implemented by practical validation method with following parameters: accuracy, repeatability, and intermediate precision of the potency method for Japanese encephalitis vaccine Results of study showed that the parameters of accuracy, repeatability and intermediate precision of potency test for Japanese Encephalitis IMOJEV were all qualified and in the approved range of manufacturer: titer of standard sample was about 4.25-5.09 log PFU/0.5 ml and titer of IMOJEV was between 4.0-5.8 log PFU/0.5ml Based on our study conclussion the the potency test for Japanese Encephalitis IMOJEV after validation was qualified for accuracy, repeatability and intermediate precision with coefficient of variation CV ≤ 25% so it is suitable with laboratory condition of NICVB.