Microtitration of Rubella Virus in Monovalent Vaccinal Products

Abstract

Background: Potency test for control of rubella vaccine is a significant factor to qualify production line and vaccination pro­gram. For this reason, WHO recommends to use the microtitration method by both vaccine companies and control laborato­ries. Then the study was done to improve this test.
Methods: Three rubella virus samples, including an in-house standard, a lot of vaccine and an in- process product, were tit­tered in cell culture tubes. Then micro titration steps were tested on 96-well microplate using cocultivation of standard ru­bella vaccine dilutions and RK- 13 cell line. After 6-7 days, final reading was done and calculated the titer. Two other sam­ples were assayed with the micromethod.
Results: Titer reduction less than 0.5 log was acquired for each sample during frequent tests and between two methods.
Conclusion: The procedure was profitable and accurate for potency and identity tests of rubella virus vaccine, on the basis of WHO recommendations.