Experience with the use of pharmacopoeial reference material for the activity of measles vaccine

Abstract

Introduction. Due to the increased incidence of measles in Russia and in many other regions of the world, vaccines for the measles prevention are especially in demand. Ensuring the quality of the measles vaccine for effective disease prevention is within the scope of the tasks of the state policy of our country. Objective. Evaluation of the experience of using a pharmacopoeial standard material of measles vaccine activity for measurement of the specific activity of the measles virus in vaccines with a measles component that are used in the Russian Federation for measles prevention. Materials and methods. The object of the study was the Pharmacopoeia reference material (PRM) of the activity of the live measles vaccine of series 10. The activity of PRM was analyzed when determining the specific activity of the measles, mumps-measles and combined vaccines for the prevention of measles, rubella and mumps, as well as based on the materials of the summary protocols for the production of these vaccines. Results. The titer of the measles virus in the PRM for each determination of the specific activity of the measles virus in vaccines in the Scientific Centre for Expert Evaluation of Medicinal Products in 20212022, as well as according to the summary production protocols, was within the boundaries of the certified value (4.63 0.5) lgTCD50/0.5 ml, and the test results met the acceptance criteria in accordance with the requirements of regulatory documentation. During the observation period, the average value of the PRM titer (4.61 lgTCD50/0.5 ml) practically did not differ compared to the average value of the certified characteristics of the PRM, the standard deviation of the mean value of the measles virus titer in the PRM did not exceed 0.15 lgTCD50, which indicated the stability of the analytical work at the enterprise and in IC. Conclusion. The data obtained indicate the stable activity of PRM, the correctness of the determination of the measles virus titer in the vaccination dose of the vaccine, and the validity of the method for monitoring the specific activity of the measles virus in vaccines.