Certification and shelf-life extension of a new batch of the branch reference standard for live tularemic vaccine's specific activity and immunogenicity
| Title: | Certification and shelf-life extension of a new batch of the branch reference standard for live tularemic vaccine's specific activity and immunogenicity |
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| Authors: | I. V. Kasina, A. A. Goryaev, L. I. Rashchepkin, O. V. Fadeykina, T. I. Nemirovskaya, O. B. Ustinnikova, O. A. Lobovikova, S. A. Alekseeva, R. A. Volkova, A. A. Movsesyants |
| Source: | Биопрепараты: Профилактика, диагностика, лечение, Vol 0, Iss 4, Pp 32-38 (2018) |
| Publisher Information: | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2018. |
| Publication Year: | 2018 |
| Collection: | LCC:Biotechnology LCC:Medicine |
| Subject Terms: | отраслевой стандартный образец (осо), вакцина туляремийная живая, фармакопейная статья предприятия (фсп), специфическая активность, концентрация микробных клеток, процент живых микробных клеток, степень диссоциации (процент sr (белых) иммуногенных колоний от общего количества выросших), иммуногенность, dosis certe letalis (dcl), термостабильность, branch reference standard (brs), live tularemic vaccine, manufacturer’s monograph (mm), specific activity, microbial cells concentration, percentage of living microbial cells, dissociation degree, immunogenicity, thermal stability, Biotechnology, TP248.13-248.65, Medicine |
| More Details: | The article presents the results obtained in the study of a new batch of a candidate branch reference standard for live tularemic vaccine (vaccine BRS). The candidate vaccine BRS was represented by a commercial batch of a product that met all applicable requirements of the manufacturer’s monograph (MM) for live tularemic vaccine’s quality attributes. The candidate vaccine BRS was certified for specific activity including a range of parameters, such as: microbial cells concentration, percentage of living microbial cells, dissociation degree (percent of SR (white) immunogenic colonies from the total number of colonies grown), as well as immunogenicity. Results of analysis that addressed the use of this batch of vaccine BRS and its quality attributes made it possible to extend the shelf-life of the product for 6 months. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | Russian |
| ISSN: | 2221-996X 2619-1156 |
| Relation: | https://www.biopreparations.ru/jour/article/view/31; https://doaj.org/toc/2221-996X; https://doaj.org/toc/2619-1156 |
| Access URL: | https://doaj.org/article/402089cd51bf4536ab529a98c07a863a |
| Accession Number: | edsdoj.402089cd51bf4536ab529a98c07a863a |
| Database: | Directory of Open Access Journals |
| ISSN: | 2221996X 26191156 |
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| Published in: | Биопрепараты: Профилактика, диагностика, лечение |
| Language: | Russian |