Certification of a New Batch of the Industry Reference Standard of Polysaccharide Content in Schigellvac Vaccine
The article summarises materials on the certification of the industry reference standard of Schigella sonnei polysaccharide dysentery vaccine (commercial name — Schigellvac). The industry reference standard is used to assess the consistency of the vaccine «Specific activity» testing by passive hemag...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-12-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
| Subjects: | |
| Online Access: | https://www.biopreparations.ru/jour/article/view/198 |
| _version_ | 1797244502141829120 |
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| author | V. A. Volkov M. V. Abramtseva T. I. Nemirovskaya V. P. Kovtun O. V. Fadeykina R. A. Volkova |
| author_facet | V. A. Volkov M. V. Abramtseva T. I. Nemirovskaya V. P. Kovtun O. V. Fadeykina R. A. Volkova |
| author_sort | V. A. Volkov |
| collection | DOAJ |
| description | The article summarises materials on the certification of the industry reference standard of Schigella sonnei polysaccharide dysentery vaccine (commercial name — Schigellvac). The industry reference standard is used to assess the consistency of the vaccine «Specific activity» testing by passive hemagglutination inhibition assay. A certification programme for the industry reference standard was developed. Samples of the candidate vaccine were tested in terms of the following quality characteristics: «Appearance», «Identification», «Extractable Volume». The test results confirmed that the samples comply with the current requirements of the manufacturer’s product specification file for Schigellvac vaccine. It was determined that the certification parameter — the polysaccharide dilution ratio which results in inhibition of passive hemagglutination in a homologous system — has to fall in the range from 1:128 to 1:512. The following set of standard documents accompanying a scientific/technological product was approved for the industry reference standard No. 42-28-386-2017: passport, patient information leaflet, mockup labels for primary and secondary packaging. |
| first_indexed | 2024-03-08T21:44:17Z |
| format | Article |
| id | doaj.art-a6af1d41a6834aa093e45404a9df1756 |
| institution | Directory Open Access Journal |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| last_indexed | 2024-04-24T19:12:01Z |
| publishDate | 2018-12-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj.art-a6af1d41a6834aa093e45404a9df17562024-03-26T09:10:52ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-12-0118425726110.30895/2221-996X-2018-18-4-257-261150Certification of a New Batch of the Industry Reference Standard of Polysaccharide Content in Schigellvac VaccineV. A. Volkov0M. V. Abramtseva1T. I. Nemirovskaya2V. P. Kovtun3O. V. Fadeykina4R. A. Volkova5Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe article summarises materials on the certification of the industry reference standard of Schigella sonnei polysaccharide dysentery vaccine (commercial name — Schigellvac). The industry reference standard is used to assess the consistency of the vaccine «Specific activity» testing by passive hemagglutination inhibition assay. A certification programme for the industry reference standard was developed. Samples of the candidate vaccine were tested in terms of the following quality characteristics: «Appearance», «Identification», «Extractable Volume». The test results confirmed that the samples comply with the current requirements of the manufacturer’s product specification file for Schigellvac vaccine. It was determined that the certification parameter — the polysaccharide dilution ratio which results in inhibition of passive hemagglutination in a homologous system — has to fall in the range from 1:128 to 1:512. The following set of standard documents accompanying a scientific/technological product was approved for the industry reference standard No. 42-28-386-2017: passport, patient information leaflet, mockup labels for primary and secondary packaging.https://www.biopreparations.ru/jour/article/view/198industry reference standardschigellvacschigella sonnei polysaccharide dysentery vaccinequality characteristicsspecific activityshigellashigellosispassive hemagglutination inhibition assay |
| spellingShingle | V. A. Volkov M. V. Abramtseva T. I. Nemirovskaya V. P. Kovtun O. V. Fadeykina R. A. Volkova Certification of a New Batch of the Industry Reference Standard of Polysaccharide Content in Schigellvac Vaccine Биопрепараты: Профилактика, диагностика, лечение industry reference standard schigellvac schigella sonnei polysaccharide dysentery vaccine quality characteristics specific activity shigella shigellosis passive hemagglutination inhibition assay |
| title | Certification of a New Batch of the Industry Reference Standard of Polysaccharide Content in Schigellvac Vaccine |
| title_full | Certification of a New Batch of the Industry Reference Standard of Polysaccharide Content in Schigellvac Vaccine |
| title_fullStr | Certification of a New Batch of the Industry Reference Standard of Polysaccharide Content in Schigellvac Vaccine |
| title_full_unstemmed | Certification of a New Batch of the Industry Reference Standard of Polysaccharide Content in Schigellvac Vaccine |
| title_short | Certification of a New Batch of the Industry Reference Standard of Polysaccharide Content in Schigellvac Vaccine |
| title_sort | certification of a new batch of the industry reference standard of polysaccharide content in schigellvac vaccine |
| topic | industry reference standard schigellvac schigella sonnei polysaccharide dysentery vaccine quality characteristics specific activity shigella shigellosis passive hemagglutination inhibition assay |
| url | https://www.biopreparations.ru/jour/article/view/198 |
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