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

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