Patent EA-002387-B1 (EA)
Title: Method of production of a combined mumps measles vaccine
Inventor: ZAITSEV IGOR ZAKVANOVICH
IPC: A61K39/165
Filed: 2000-12-19
Abstract: 1. Method of production of a combined mumps-measles vaccine which includes infection of primary quail embryo cell culture with mumps and measles viruses, incubation in growth medium containing growth proteins, subsequent rinsing up of the cell culture, incubation and harvesting of virus-containing fluid, characterized in that the mumps and measles viruses are incubated separately in the presence of antibiotic, harvested virus-containing fluid is subjected to clarifying filtration, then stabilizer is added and the fluids are pooled in proportions conforming final vaccination doses: not less than 20,000 TCID50/0.5 ml of mumps component, not less than 1,000 TCID50/0.5 ml of measles component then the preparation is lyophilized. 2. Method according to claim 1, characterized in that mumps virus strain L-3 and measles virus strain L-16 are used as vaccine strains. 3. Method according to claim 2, characterized in that plurality of infection is 0.00001 - 0.001 TCID50 per cell for the mumps virus strain and is 0.001 - 0.01 TCID50 per cell for the measles virus strain. 4. Method according to claim 1, characterized in that incubation is carried out at the temperature from + 34  degree  C to + 36  degree C. 5. Method according to claim 1, characterized in that incubation is carried out in roller plants. 6. Method according to claim 1, characterized in that incubation is carried out in stationary conditions.  7. Method according to claim 1, characterized in that rinsing up of cell culture with supporting medium is carried out not less than 6 times both for mumps and measles components. 8. Method according to claim 1, characterized in that LS-18 with gelatin or sorbitol with gelatose are used as stabilizers. 9. Method according to claim 8, characterized in that polyglucinum or poly-N-vinylpirrolidonum is used as one of stabilizers instead of gelatin or gelatose. 10. Method according to claims 8 or 9, characterized in that poly-N- vinylpirrolidonum with molecular mass not less than 12 kD is used. 11. Method according to claim 1, characterized in that quantity of protein in the combined vaccine does not exceed 8 μg/dose. 12. Method according to claim 1, characterized in that freezing during lyophilization is carried out at the temperature from - 30  degree  C to - 55  degree  C for 3 - 6 hours. 13. Method according to claim 1, characterized in that desiccation during lyophilization is carried out at the temperature from - 17  degree  C to - 28  degree  C for 24 - 60 hours with subsequent heating up to temperature from + 22  degree  C to + 28  degree  C for 8 - 14 hours. 14. Method according to claim 1, characterized in that combined vaccine is prepared with the given concentrations of components determined according to the formula:  Q = T2/T1 * N Where: Q - volume of each starting component, in litres; T1 - starting activity of a component, in TCID50/0.5 ml; T2 - given activity of a component in the combined preparation, in TCID50/0.5 ml; N - given volume of the combined preparation, in litres.