Evaluation of a new series of branch reference standard of live measles vaccine activity
Presents information on series of branch reference standard 42-28-347-2014 of live measles vaccine activity used in the evaluation of the specific activity of monovalent live measles vaccine and associate products with the measles component. To confirm the quality of the candidate of branch reference standard tested for performance evaluation: specific activity of authenticity, a description of sterility, presence of mycoplasma, loss on drying, pH, filling accuracy, the residual oxygen content in the vials. Attested feature of the new series of the standard sample is a specific activity, because the purpose of the of branch reference standard activity live measles vaccine is the suitability of the results of determining the specific activity of the measles virus in vaccines. Indicator specific activity of the candidate in the branch reference standard was assessed by interlaboratory studies compared to current branch reference standard 42-28-347-11P and the Second International Reference Reagent live measles vaccine NIBSC-92/648. Certified value of the index is set «Specific activity of a new series of branch reference standard activity live measles vaccine» (4.54 ± 0.50)log CCID 50 /0.5 ml. With the accelerated test thermodegradation predicted long-term stability of branch reference standard when stored at minus 200C. In the study of quality of the candidate in the branch reference standard activity live measles vaccine take into account the recommendations of the WHO Guidelines for the preparation of biological standards.