Prospects for improving evaluation of live tularemia vaccine quality
Abstract
Keywords
About the Authors
I. V. KasinaRussian Federation
Chief expert of the Laboratory of Bacterial Vaccines of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
S. A. Alekseeva
Russian Federation
Leading expert of the Laboratory of Bacterial Vaccines of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
Z. E. Berdnikova
Russian Federation
Chief expert of the Laboratory of Bacteriological Culture Media and Cell Cultures of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences
T. I. Nemirovskaya
Russian Federation
Head of the Laboratory of Bacterial Vaccines of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Medical Sciences
A. S. Alekhina
Russian Federation
Lab technician of the Laboratory of Bacteriological Culture Media and Cell Cultures of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality
References
1. Kasina IV, Goryaev AA, Rashchepkin LI, Fadeykina OV, Nemirovskaya TI, Ustinnikova OB et al. Certification and shelf-life extension of a new batch of the branch reference standard for live tularemic vaccine’s specific activity and immunogenicity. BIOpreparations. Prevention, Diagnosis, Treatment 2015; (4): 32–8 (in Russian).
2. Kasina IV, Raschepkin LI, Goryaev AA, Alekseeva SA, Nemirovskaya TI, Movsesyants AA. Live tularemia vaccine quality assessment according to test results under the mandatory certification. BIOpreparations. Prevention, Diagnosis, Treatment 2016; 16(4): 253–9 (in Russian).
3. Movsesyants AA, Mironov AN, Merkulov VA, Borisevich IV. Aims and objectives Testing Center for Quality Expertise of Medical Immunobiological Preparations. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2012; (1): 7–9 (in Russian).
4. Movsesyants AA, Bondarev VP, Olefir YuV, Merkulov VA, Shimchuk LF. Quality standards for immunobiological medicinal products — new texts in the State Pharmacopoeia of the Russian Federation. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2016; (2): 38–41 (in Russian).
5. OFS.3.3.1.0019.15. The tularemia vaccine live. State Pharmacopoeia of the Russian Federation. 13th ed. V. 3. P. 923–30. Available from: http://www.femb.ru/feml (in Russian).
6. OFS.1.8.1.0002.15. Immunobiological medicinal products. State Pharmacopoeia of the Russian Federation. 13th ed. V. 2. P. 867–79. Available from: http://www.femb.ru/feml (in Russian).
7. Laboratory diagnosis of infectious diseases. A practical guide. Onishchenko GG, Kutyrev VV, eds. Moscow: «Shiko»; 2013. P. 522–3 (in Russian).
8. Dyatlov IA, Kutyrev VV, Khramov MV. Nutrient medium for isolation, cultivation and identification of pathogens of especially dangerous infections of bacterial nature. Moscow; 2012. P. 383–90 (in Russian).
9. Shebalin IA, Mironov AYu, Shepelin KA. causative Agents of especially dangerous bacterial infections. Reference bacteriologist. Moscow; 2016 (in Russian).
10. Meshcheryakova IS. Taxonomy, identification and immunological diagnosis of tularemia. Dr. Med. Sci. [authoref. dissertation] Moscow; 1990 (in Russian).
11. Pozdeev OK. Medical Microbiology. Moscow; 2004. P. 392–4 (in Russian).
12. OFS.1.2.4.0003.15. Sterility. State Pharmacopoeia of the Russian Federation. 13th ed. V. 1. P. 925–46. Available from: http:// www.femb.ru/feml (in Russian).
Review
For citations:
Kasina I.V., Alekseeva S.A., Berdnikova Z.E., Nemirovskaya T.I., Alekhina A.S. Prospects for improving evaluation of live tularemia vaccine quality. BIOpreparations. Prevention, Diagnosis, Treatment. 2017;17(4):240-247. (In Russ.)