Increased safety level of serotype 3 sabin oral poliomyelitis vaccine lots by improved seed virus, and tissue culture and virus infection conditions
The content of 472U to 472C revertant virus in serotype 3 oral poliomyelitis monovalent bulk vaccines can be quantified by MAPREC (Mutant Analysis by PCR and Restriction Enzyme Cleavage). Besides other wildtype reversions identified in propagated type 3 Sabin strain populations, the 472U to 472C rev...
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| Veröffentlicht in: | Vaccine 2000-05, Vol.18 (22), p.2435-2443 |
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| creator | Dörsam, Volker Weimer, Thomas Schmeel, Andreas Hein, Berndt Enssle, Karlheinz Chumakov, Konstantin M Fibi, Mathias R |
| description | The content of 472U to 472C revertant virus in serotype 3 oral poliomyelitis monovalent bulk vaccines can be quantified by MAPREC (Mutant Analysis by PCR and Restriction Enzyme Cleavage). Besides other wildtype reversions identified in propagated type 3 Sabin strain populations, the 472U to 472C reversion correlates most prominently with neurovirulence in the monkey neurovirulence test. Therefore, the results can be used for the discrimination of ‘good’ and ‘bad’ vaccines on the molecular level. In international collaborative studies it has been well established that vaccine lots containing revertant genomes below a critical threshold pass the in vivo monkey neurovirulence test (MNVT), while vaccine lots containing more revertants fail the MNVT. In this communication we show that the MAPREC test is a sensitive tool for quality control and the demonstration of consistency in large scale production. Furthermore, MAPREC offers a possibility to assess the effect of changed production conditions on the rate of reversion and to find conditions for consistent production with low reversion rates. |
| doi_str_mv | 10.1016/S0264-410X(99)00531-9 |
| format | Article |
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Besides other wildtype reversions identified in propagated type 3 Sabin strain populations, the 472U to 472C reversion correlates most prominently with neurovirulence in the monkey neurovirulence test. Therefore, the results can be used for the discrimination of ‘good’ and ‘bad’ vaccines on the molecular level. In international collaborative studies it has been well established that vaccine lots containing revertant genomes below a critical threshold pass the in vivo monkey neurovirulence test (MNVT), while vaccine lots containing more revertants fail the MNVT. In this communication we show that the MAPREC test is a sensitive tool for quality control and the demonstration of consistency in large scale production. 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Besides other wildtype reversions identified in propagated type 3 Sabin strain populations, the 472U to 472C reversion correlates most prominently with neurovirulence in the monkey neurovirulence test. Therefore, the results can be used for the discrimination of ‘good’ and ‘bad’ vaccines on the molecular level. In international collaborative studies it has been well established that vaccine lots containing revertant genomes below a critical threshold pass the in vivo monkey neurovirulence test (MNVT), while vaccine lots containing more revertants fail the MNVT. In this communication we show that the MAPREC test is a sensitive tool for quality control and the demonstration of consistency in large scale production. 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| subjects | Animals Biological and medical sciences Biotechnology Fundamental and applied biological sciences. Psychology Genetic Markers Genome, Viral Haplorhini Health. Pharmaceutical industry Humans Industrial applications and implications. Economical aspects MAPREC Mutational analysis Oral poliovirus vaccine Point Mutation Poliovirus - classification Poliovirus - genetics Poliovirus - immunology Poliovirus Vaccine, Oral - adverse effects Poliovirus Vaccine, Oral - genetics Poliovirus Vaccine, Oral - isolation & purification Production of active biomolecules Quality control Safety Serotyping Vaccins Virulence - genetics Virus Cultivation |
| title | Increased safety level of serotype 3 sabin oral poliomyelitis vaccine lots by improved seed virus, and tissue culture and virus infection conditions |
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