10 research outputs found
ΠΡΠ΅Π½ΠΊΠ° ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Π΅ΠΉ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΠΎΡΠ΅ΡΠ΅ΡΡΠ²Π΅Π½Π½ΠΎΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ ΠΏΡΠΎΡΠΈΠ² Π³ΡΠΈΠΏΠΏΠ°, ΠΏΡΠ΅Π΄Π½Π°Π·Π½Π°ΡΠ΅Π½Π½ΠΎΠΉ Π΄Π»Ρ ΠΈΠΌΠΌΡΠ½ΠΈΠ·Π°ΡΠΈΠΈ Π½Π°ΡΠ΅Π»Π΅Π½ΠΈΡ Π² ΡΠ΅ΡΠ΅Π½ΠΈΠ΅ ΡΠΏΠΈΠ΄Π΅ΠΌΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΡΠ΅Π·ΠΎΠ½Π° 2017β2018 Π³Π³.
The efficacy of influenza vaccines has been a matter of considerable debate ever since the development of theΒ first influenza vaccine. The efficacy of currently used influenza vaccines depends on manyΒ factors, including theΒ strain composition, the degree of homologyΒ between the produced and epidemic influenza viruses, theΒ vaccinationΒ coverage, and many other factors. Assessment of quality, i.e. determination of compliance of the productβsΒ qualityΒ characteristics with the specification requirements, and assessmentΒ of risks associated with the use of theΒ product were considered onlyΒ in the context of general requirements for the quality of biologicals.Β The article summarisesΒ the results of analysis of batch to batchΒ consistency of the influenza inactivated polymer-subunit vaccine.Β The study included a retrospective assessment of the dataΒ obtained during the product release control and testingΒ performed by an accredited testing centre as part of mandatory certification. TheΒ data obtained may be used toΒ improve the production method andΒ the system of statistical management of the production process, asΒ well as toΒ assess the risks accompanying the production of influenza vaccine at each of the stages.ΠΠΎΠΏΡΠΎΡ ΠΎΠ± ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ Π²Π°ΠΊΡΠΈΠ½ ΠΏΡΠΎΡΠΈΠ² Π³ΡΠΈΠΏΠΏΠ° ΠΏΡΠΎΠ΄ΠΎΠ»ΠΆΠ°Π΅Ρ Π±ΡΡΡ Π°ΠΊΡΡΠ°Π»ΡΠ½ΡΠΌ ΠΈ ΡΠΈΡΠΎΠΊΠΎ ΠΎΠ±ΡΡΠΆΠ΄Π°Π΅ΠΌΡΠΌΒ ΡΠΎ Π²ΡΠ΅ΠΌΠ΅Π½ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΏΠ΅ΡΠ²ΠΎΠΉ ΠΏΡΠΎΡΠΈΠ²ΠΎΠ³ΡΠΈΠΏΠΏΠΎΠ·Π½ΠΎΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ. ΠΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΒ ΡΠΎΠ²ΡΠ΅ΠΌΠ΅Π½Π½ΡΡ
Π²Π°ΠΊΡΠΈΠ½ Π·Π°Π²ΠΈΡΠΈΡ ΠΎΡ ΠΌΠ½ΠΎΠ³ΠΈΡ
ΡΠ°ΠΊΡΠΎΡΠΎΠ², Π² ΡΠΎΠΌ ΡΠΈΡΠ»Π΅ ΠΎΡ ΡΡΠ°ΠΌΠΌΠΎΠ²ΠΎΠ³ΠΎ ΡΠΎΡΡΠ°Π²Π°,Β ΡΡΠ΅ΠΏΠ΅Π½ΠΈ Π³ΠΎΠΌΠΎΠ»ΠΎΠ³ΠΈΠΈ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½Π½ΡΡ
Β ΠΈ ΡΠΏΠΈΠ΄Π΅ΠΌΠΈΡΠ΅ΡΠΊΠΈΡ
Π²ΠΈΡΡΡΠΎΠ² Π³ΡΠΈΠΏΠΏΠ°, ΠΎΡ
Π²Π°ΡΠ° Π½Π°ΡΠ΅Π»Π΅Π½ΠΈΡΒ ΠΏΡΠΎΡΠΈΠ»Π°ΠΊΡΠΈΡΠ΅ΡΠΊΠΈΠΌΠΈ ΠΏΡΠΈΠ²ΠΈΠ²ΠΊΠ°ΠΌΠΈ, Π΄ΡΡΠ³ΠΈΡ
Π°ΡΠΏΠ΅ΠΊΡΠΎΠ².Β ΠΠΎΠΏΡΠΎΡ ΠΎΡΠ΅Π½ΠΊΠΈ ΠΊΠ°ΡΠ΅ΡΡΠ²Π°, Π²ΡΡΠ°ΠΆΠ°ΡΡΠΈΠΉΡΡΒ Π² ΠΎΠΏΡΠ΅Π΄Π΅Π»Π΅Π½ΠΈΠΈ ΡΠΎΠΎΡΠ²Π΅ΡΡΡΠ²ΠΈΡ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Π΅ΠΉ ΠΊΠ°ΡΠ΅ΡΡΠ²Π° ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡΠΌ ΡΠΏΠ΅ΡΠΈΡΠΈΠΊΠ°ΡΠΈΠΈ Π½ΠΎΡΠΌΠ°ΡΠΈΠ²Π½ΠΎΠΉΒ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΠ°ΡΠΈΠΈ, ΠΊΠ°ΠΊ ΠΈ Π²ΠΎΠΏΡΠΎΡ ΠΎΡΠ΅Π½ΠΊΠΈ ΡΠΈΡΠΊΠΎΠ² ΠΏΡΠΈ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠΈ Π²Π°ΠΊΡΠΈΠ½Β ΠΏΡΠΎΡΠΈΠ² Π³ΡΠΈΠΏΠΏΠ°,Β ΡΠ°ΡΡΠΌΠ°ΡΡΠΈΠ²Π°Π»ΡΡ Π»ΠΈΡΡ Π² ΠΊΠΎΠ½ΡΠ΅ΠΊΡΡΠ΅ ΠΎΠ±ΡΠΈΡ
ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΠΉ ΠΊ ΠΊΠ°ΡΠ΅ΡΡΠ²Ρ ΠΈΠΌΠΌΡΠ½ΠΎΠ±ΠΈΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΡ
Β ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ². Π Π½Π°ΡΡΠΎΡΡΠ΅ΠΉ ΡΡΠ°ΡΡΠ΅ ΠΏΡΠΈΠ²Π΅Π΄Π΅Π½Ρ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ Π°Π½Π°Π»ΠΈΠ·Π°Β ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ ΠΏΠΎΠΊΠ°Π·Π°ΡΠ΅Π»Π΅ΠΉ ΠΊΠ°ΡΠ΅ΡΡΠ²Π°Β Π½Π° ΠΏΡΠΈΠΌΠ΅ΡΠ΅ ΡΠ΅ΡΠΈΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ Π³ΡΠΈΠΏΠΏΠΎΠ·Π½ΠΎΠΉΒ ΠΈΠ½Π°ΠΊΡΠΈΠ²ΠΈΡΠΎΠ²Π°Π½Π½ΠΎΠΉ ΠΏΠΎΠ»ΠΈΠΌΠ΅Ρ-ΡΡΠ±ΡΠ΅Π΄ΠΈΠ½ΠΈΡΠ½ΠΎΠΉ. ΠΡΠΎΠ²Π΅Π΄Π΅Π½Π° ΡΠ΅ΡΡΠΎΡΠΏΠ΅ΠΊΡΠΈΠ²Π½Π°Ρ ΠΎΡΠ΅Π½ΠΊΠ° Π΄Π°Π½Π½ΡΡ
Β Π²ΡΠΏΡΡΠΊΠ°ΡΡΠ΅Π³ΠΎ ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ° ΠΈ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠΎΠ² ΠΈΡΠΏΡΡΠ°Π½ΠΈΠΉ, ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½Π½ΡΡ
Β Π²Β Π°ΠΊΠΊΡΠ΅Π΄ΠΈΡΠΎΠ²Π°Π½Π½ΠΎΠΌ ΠΈΡΠΏΡΡΠ°ΡΠ΅Π»ΡΠ½ΠΎΠΌ ΡΠ΅Π½ΡΡΠ΅, Π² ΡΠ°ΠΌΠΊΠ°Ρ
ΠΎΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎΠΉ ΡΠ΅ΡΡΠΈΡΠΈΠΊΠ°ΡΠΈΠΈ. ΠΠΎΠ»ΡΡΠ΅Π½Π½ΡΠ΅ Π΄Π°Π½Π½ΡΠ΅Β ΠΌΠΎΠ³ΡΡ Π±ΡΡΡ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½Ρ ΠΏΡΠΈ ΡΠΎΠ²Π΅ΡΡΠ΅Π½ΡΡΠ²ΠΎΠ²Π°Π½ΠΈΠΈ ΡΠ΅Ρ
Π½ΠΎΠ»ΠΎΠ³ΠΈΠΈ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° ΠΈΒ ΡΠΈΡΡΠ΅ΠΌΡ ΡΡΠ°ΡΠΈΡΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎΒ ΡΠΏΡΠ°Π²Π»Π΅Π½ΠΈΡ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΠΏΡΠΎΡΠ΅ΡΡΠ°, Π΄Π»Ρ ΠΎΡΠ΅Π½ΠΊΠΈ ΡΠΈΡΠΊΠΎΠ²,Β ΡΠΎΠΏΡΠΎΠ²ΠΎΠΆΠ΄Π°ΡΡΠΈΡ
ΠΏΡΠΎΡΠ΅ΡΡ ΠΏΡΠΈΠ³ΠΎΡΠΎΠ²Π»Π΅Π½ΠΈΡΒ Π³ΡΠΈΠΏΠΏΠΎΠ·Π½ΠΎΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ Π½Π° ΠΊΠ°ΠΆΠ΄ΠΎΠΌ ΠΈΠ· Π΅Π³ΠΎ ΡΡΠ°ΠΏΠΎΠ²
Π Π΅Π΄Π°ΠΊΡΠΈΡΠΎΠ²Π°Π½ΠΈΠ΅ Π³Π΅Π½ΠΎΠΌΠ° ΠΈ Π±ΠΈΠΎΠΌΠ΅Π΄ΠΈΡΠΈΠ½ΡΠΊΠΈΠ΅ ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΠ΅ ΠΏΡΠΎΠ΄ΡΠΊΡΡ: ΡΠΎΠ²ΡΠ΅ΠΌΠ΅Π½Π½ΠΎΠ΅ ΡΠΎΡΡΠΎΡΠ½ΠΈΠ΅, Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎΡΡΡ ΠΈ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ
Advances in ex vivo technologies of human genome editing have made it possible to develop new approaches to the treatment of genetic, oncological, infectious and other diseases, which may involve the use of biomedical cell products. However, despite the rapid development of these technologies and a large number of clinical trials conducted in many countries around the world, only 4 products (Strimvelis, Zalmoxis, Kymriah and Yescarta) containing ex vivo genetically modified human cells are authorised for use in the European Union and the United States of America. This paper considers three promising technologies (ZFN, TALEN and CRISPR) that allow for easy and effective editing of the genome at the sites of interest, thereby creating a platform for further development of the genetic engineering of human cells. It describes the technology of engineering chimeric antigen receptors (CARs). It also provides data on the efficacy and safety of the approved products: Strimvelis which contains autologous CD34+ cells transduced ex vivo with a retroviral vector containing adenosine deaminase gene, Zalmoxis which contains modified allogeneic T-cells, and two products: Kymriah and Yescarta which contain autologous T-cells with CARs to CD19 antigen, intended for the treatment of CD19+ hematological malignancies.Π£ΡΠΏΠ΅Ρ
ΠΈ Π² ΡΠ΅Ρ
Π½ΠΎΠ»ΠΎΠ³ΠΈΡΡ
ex vivo ΡΠ΅Π΄Π°ΠΊΡΠΈΡΠΎΠ²Π°Π½ΠΈΡ Π³Π΅Π½ΠΎΠΌΠ° ΡΠ΅Π»ΠΎΠ²Π΅ΠΊΠ° ΠΏΠΎΠ·Π²ΠΎΠ»ΠΈΠ»ΠΈ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠ°ΡΡ Π½ΠΎΠ²ΡΠ΅ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄Ρ Π² Π»Π΅ΡΠ΅Π½ΠΈΠΈ Π³Π΅Π½Π΅ΡΠΈΡΠ΅ΡΠΊΠΈΡ
, ΡΠΊΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΡ
, ΠΈΠ½ΡΠ΅ΠΊΡΠΈΠΎΠ½Π½ΡΡ
ΠΈ Π΄ΡΡΠ³ΠΈΡ
Π·Π°Π±ΠΎΠ»Π΅Π²Π°Π½ΠΈΠΉ, Π² ΡΠΎΠΌ ΡΠΈΡΠ»Π΅ Ρ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ Π±ΠΈΠΎΠΌΠ΅Π΄ΠΈΡΠΈΠ½ΡΠΊΠΈΡ
ΠΊΠ»Π΅ΡΠΎΡΠ½ΡΡ
ΠΏΡΠΎΠ΄ΡΠΊΡΠΎΠ². ΠΠΎ, Π½Π΅ΡΠΌΠΎΡΡΡ Π½Π° Π±ΡΡΡΡΠΎΠ΅ ΡΠ°Π·Π²ΠΈΡΠΈΠ΅ Π΄Π°Π½Π½ΡΡ
ΡΠ΅Ρ
Π½ΠΎΠ»ΠΎΠ³ΠΈΠΉ ΠΈ Π±ΠΎΠ»ΡΡΠΎΠ΅ ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²ΠΎ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠΌΡΡ
ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ Π²ΠΎ ΠΌΠ½ΠΎΠ³ΠΈΡ
ΡΡΡΠ°Π½Π°Ρ
ΠΌΠΈΡΠ°, ΡΠΎΠ»ΡΠΊΠΎ 4 ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ° (Strimvelis, Zalmoxis, Kymriah ΠΈ Yescarta), ΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠΈΠ΅ ex vivo Π³Π΅Π½Π½ΠΎ-ΠΌΠΎΠ΄ΠΈΡΠΈΡΠΈΡΠΎΠ²Π°Π½Π½ΡΠ΅ ΠΊΠ»Π΅ΡΠΊΠΈ ΡΠ΅Π»ΠΎΠ²Π΅ΠΊΠ°, ΡΠ°Π·ΡΠ΅ΡΠ΅Π½Ρ ΠΊ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ Π² ΡΡΡΠ°Π½Π°Ρ
ΠΠ²ΡΠΎΠΏΠ΅ΠΉΡΠΊΠΎΠ³ΠΎ ΡΠΎΡΠ·Π° ΠΈ Π‘Π¨Π. Π Π΄Π°Π½Π½ΠΎΠΉ ΡΠ°Π±ΠΎΡΠ΅ ΡΠ°ΡΡΠΌΠΎΡΡΠ΅Π½Ρ ΡΡΠΈ ΠΏΠ΅ΡΡΠΏΠ΅ΠΊΡΠΈΠ²Π½ΡΠ΅ ΡΠ΅Ρ
Π½ΠΎΠ»ΠΎΠ³ΠΈΠΈ (ZFN, TALEN ΠΈ CRISPR), ΠΏΠΎΠ·Π²ΠΎΠ»ΡΡΡΠΈΠ΅ Π»Π΅Π³ΠΊΠΎ ΠΈ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΡΡ ΡΠ΅Π΄Π°ΠΊΡΠΈΡΠΎΠ²Π°Π½ΠΈΠ΅ Π³Π΅Π½ΠΎΠΌΠ° Π² Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΡΡ
ΡΠ°ΠΉΡΠ°Ρ
, ΡΠ΅ΠΌ ΡΠ°ΠΌΡΠΌ ΡΠΎΠ·Π΄Π°Π²Π°Ρ ΠΏΠ»Π°ΡΡΠΎΡΠΌΡ Π΄Π»Ρ Π΄Π°Π»ΡΠ½Π΅ΠΉΡΠ΅Π³ΠΎ ΡΠ°Π·Π²ΠΈΡΠΈΡ Π³Π΅Π½Π½ΠΎΠΉ ΠΈΠ½ΠΆΠ΅Π½Π΅ΡΠΈΠΈ ΠΊΠ»Π΅ΡΠΎΠΊ ΡΠ΅Π»ΠΎΠ²Π΅ΠΊΠ°. ΠΠΏΠΈΡΠ°Π½Π° ΡΠ΅Ρ
Π½ΠΎΠ»ΠΎΠ³ΠΈΡ ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΡ Ρ
ΠΈΠΌΠ΅ΡΠ½ΡΡ
Π°Π½ΡΠΈΠ³Π΅Π½Π½ΡΡ
ΡΠ΅ΡΠ΅ΠΏΡΠΎΡΠΎΠ² (CAR). Π’Π°ΠΊΠΆΠ΅ ΠΏΡΠΈΠ²Π΅Π΄Π΅Π½Ρ ΡΠ²Π΅Π΄Π΅Π½ΠΈΡ ΠΎΠ± ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΈ Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎΡΡΠΈ ΠΎΠ΄ΠΎΠ±ΡΠ΅Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ²: Strimvelis, ΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠ΅Π³ΠΎ Π°ΡΡΠΎΠ»ΠΎΠ³ΠΈΡΠ½ΡΠ΅ CD34+-ΠΊΠ»Π΅ΡΠΊΠΈ, ex vivo ΡΡΠ°Π½ΡΠ΄ΡΡΠΈΡΠΎΠ²Π°Π½Π½ΡΠ΅ ΡΠ΅ΡΡΠΎΠ²ΠΈΡΡΡΠ½ΡΠΌ Π²Π΅ΠΊΡΠΎΡΠΎΠΌ Ρ Π³Π΅Π½ΠΎΠΌ Π°Π΄Π΅Π½ΠΎΠ·ΠΈΠ½Π΄Π΅Π·Π°ΠΌΠΈΠ½Π°Π·Ρ, Zalmoxis, ΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠ΅Π³ΠΎ ΠΌΠΎΠ΄ΠΈΡΠΈΡΠΈΡΠΎΠ²Π°Π½Π½ΡΠ΅ Π°Π»Π»ΠΎΠ³Π΅Π½Π½ΡΠ΅ Π’-ΠΊΠ»Π΅ΡΠΊΠΈ, Π° ΡΠ°ΠΊΠΆΠ΅ Π΄Π²ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² Kymriah ΠΈ Yescarta, ΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠΈΡ
Π°ΡΡΠΎΠ»ΠΎΠ³ΠΈΡΠ½ΡΠ΅ T-ΠΊΠ»Π΅ΡΠΊΠΈ Ρ Ρ
ΠΈΠΌΠ΅ΡΠ½ΡΠΌΠΈ Π°Π½ΡΠΈΠ³Π΅Π½Π½ΡΠΌΠΈ ΡΠ΅ΡΠ΅ΠΏΡΠΎΡΠ°ΠΌΠΈ ΠΊ Π°Π½ΡΠΈΠ³Π΅Π½Ρ CD19, ΠΏΡΠ΅Π΄Π½Π°Π·Π½Π°ΡΠ΅Π½Π½ΡΡ
Π΄Π»Ρ Π»Π΅ΡΠ΅Π½ΠΈΡ CD19+ Π³Π΅ΠΌΠ°ΡΠΎΠ»ΠΎΠ³ΠΈΡΠ΅ΡΠΊΠΈΡ
Π·Π»ΠΎΠΊΠ°ΡΠ΅ΡΡΠ²Π΅Π½Π½ΡΡ
Π½ΠΎΠ²ΠΎΠΎΠ±ΡΠ°Π·ΠΎΠ²Π°Π½ΠΈΠΉ
ΠΠΎΠ»Π΅ΠΊΡΠ»ΡΡΠ½ΠΎ-Π³Π΅Π½Π΅ΡΠΈΡΠ΅ΡΠΊΠΎΠ΅ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠ΅ ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ ΠΈ ΠΏΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π΅Π½ΠΈΠ΅ ΠΏΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΠΈ ΡΡΠ°ΠΌΠΌΠ° ΠΠ½ΡΠΊΠΎΠ²ΠΎ-32, ΠΏΡΠΈΠΌΠ΅Π½ΡΠ΅ΠΌΠΎΠ³ΠΎ Π΄Π»Ρ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° Π²Π°ΠΊΡΠΈΠ½Ρ Π°Π½ΡΠΈΡΠ°Π±ΠΈΡΠ΅ΡΠΊΠΎΠΉ ΠΊΡΠ»ΡΡΡΡΠ°Π»ΡΠ½ΠΎΠΉ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠΈΡΠΎΠ²Π°Π½Π½ΠΎΠΉ ΠΎΡΠΈΡΠ΅Π½Π½ΠΎΠΉ ΠΈΠ½Π°ΠΊΡΠΈΠ²ΠΈΡΠΎΠ²Π°Π½Π½ΠΎΠΉ ΡΡΡ ΠΎΠΉ
Rabies is an acute viral disease caused by a virus of the Rhabdoviridae family of the Lyssavirus genus, which affects the central nervous system and is characterised by absolute mortality. Vaccination is the only way to prevent the disease in humans. One of the products used for vaccination is a cultural concentrated purified inactivated dry rabies vaccine produced by the Federal State Budgetary Institution of Science βChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciencesβ (hereinafterβChumakov Center).The aim of the study was to examine the structure of the working virus seed of Vnukovo-32 strain used by the Chumakov Center for rabies vaccine production, to assess its genetic stability during production, to explore the possibility of using molecular genetic methods for identification of the production strain in the finished dosage form, and to study the nucleotide sequence of the CVS strain.Materials and methods: Vnukovo-32 rabies virus production strain, working virus seeds, finished batches of the rabies vaccine, CVS fixed rabies virus strain used in the assessment of specific immunity. The molecular genetic study was performed using RT-PCR followed by restriction and sequencing.Results: the paper presents the results of nucleotide sequence analysis of the G gene fragment obtained from the Vnukovo-32 production strain, batches of the working virus seed, and finished batches of the rabies vaccine produced in 2012, 2018, and 2019, and the CVS fixed rabies virus strain used in the assessment of the vaccineβs specific immunity. The study demonstrated that restriction analysis could be used for Vnukovo-32 strain identification at all production stages, including the finished dosage form.Conclusion: Vnukovo-32 and CVS strains used by the Chumakov Center are rabies viruses. Analysis of the nucleotide sequence of the G gene fragment showed that the Vnukovo-32 strain remains stable throughout different production stages. The obtained nucleotide sequence of gene G of the Vnukovo-32 strain was deposited in GenBank (accession number MN116503). The study demonstrated that restriction analysis could be used for Vnukovo-32 strain identification at all production stages, including the finished dosage form.Β ΠΠ΅ΡΠ΅Π½ΡΡΠ²ΠΎ β ΠΎΡΡΡΠ°Ρ Π²ΠΈΡΡΡΠ½Π°Ρ ΠΈΠ½ΡΠ΅ΠΊΡΠΈΡ, Π²ΡΠ·ΡΠ²Π°Π΅ΠΌΠ°Ρ Π²ΠΈΡΡΡΠΎΠΌ ΡΠ΅ΠΌΠ΅ΠΉΡΡΠ²Π° Rhabdoviridae ΡΠΎΠ΄Π° Lyssavirus ΠΈ Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΠ·ΡΡΡΠ°ΡΡΡ ΡΠΈΠΌΠΏΡΠΎΠΌΠ°ΠΌΠΈ ΠΏΠΎΡΠ°ΠΆΠ΅Π½ΠΈΡ ΡΠ΅Π½ΡΡΠ°Π»ΡΠ½ΠΎΠΉ Π½Π΅ΡΠ²Π½ΠΎΠΉ ΡΠΈΡΡΠ΅ΠΌΡ ΠΈ Π°Π±ΡΠΎΠ»ΡΡΠ½ΠΎΠΉ Π»Π΅ΡΠ°Π»ΡΠ½ΠΎΡΡΡΡ. ΠΠ΄ΠΈΠ½ΡΡΠ²Π΅Π½Π½ΠΎΠΉ Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΡΡ ΠΏΡΠ΅Π΄ΠΎΡΠ²ΡΠ°ΡΠΈΡΡ Π²ΠΎΠ·Π½ΠΈΠΊΠ½ΠΎΠ²Π΅Π½ΠΈΠ΅ Π΄Π°Π½Π½ΠΎΠ³ΠΎ Π·Π°Π±ΠΎΠ»Π΅Π²Π°Π½ΠΈΡ Ρ Π»ΡΠ΄Π΅ΠΉ ΡΠ²Π»ΡΠ΅ΡΡΡ Π²Π°ΠΊΡΠΈΠ½ΠΎΠΏΡΠΎΡΠΈΠ»Π°ΠΊΡΠΈΠΊΠ°. ΠΠ΄Π½ΠΈΠΌ ΠΈΠ· ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ², ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΠ΅ΠΌΡΡ
Π² ΡΡΠΈΡ
ΡΠ΅Π»ΡΡ
, ΡΠ²Π»ΡΠ΅ΡΡΡ Π²Π°ΠΊΡΠΈΠ½Π° Π°Π½ΡΠΈΡΠ°Π±ΠΈΡΠ΅ΡΠΊΠ°Ρ ΠΊΡΠ»ΡΡΡΡΠ°Π»ΡΠ½Π°Ρ ΠΊΠΎΠ½ΡΠ΅Π½ΡΡΠΈΡΠΎΠ²Π°Π½Π½Π°Ρ ΠΎΡΠΈΡΠ΅Π½Π½Π°Ρ ΠΈΠ½Π°ΠΊΡΠΈΠ²ΠΈΡΠΎΠ²Π°Π½Π½Π°Ρ ΡΡΡ
Π°Ρ, Π²ΡΠΏΡΡΠΊΠ°Π΅ΠΌΠ°Ρ Π€ΠΠΠΠ£ Β«Π€ΠΠ¦ΠΠ ΠΠ ΠΈΠΌ. Π.Β Π. Π§ΡΠΌΠ°ΠΊΠΎΠ²Π° Π ΠΠΒ».Π¦Π΅Π»Ρ ΡΠ°Π±ΠΎΡΡ: ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠ΅ ΡΡΡΡΠΊΡΡΡΡ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ, ΡΠ°Π±ΠΎΡΠ΅Π³ΠΎ ΠΏΠΎΡΠ΅Π²Π½ΠΎΠ³ΠΎ Π²ΠΈΡΡΡΠ° Π±Π΅ΡΠ΅Π½ΡΡΠ²Π° ΡΡΠ°ΠΌΠΌΠ° ΠΠ½ΡΠΊΠΎΠ²ΠΎ-32, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΠ΅ΠΌΠΎΠ³ΠΎ Π€ΠΠΠΠ£ Β«Π€ΠΠ¦ΠΠ ΠΠ ΠΈΠΌ. Π. Π. Π§ΡΠΌΠ°ΠΊΠΎΠ²Π° Π ΠΠΒ» Π΄Π»Ρ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π° Π°Π½ΡΠΈΡΠ°Π±ΠΈΡΠ΅ΡΠΊΠΎΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ, Π΅Π³ΠΎ Π³Π΅Π½Π΅ΡΠΈΡΠ΅ΡΠΊΠΎΠΉ ΡΡΠ°Π±ΠΈΠ»ΡΠ½ΠΎΡΡΠΈ Π½Π° ΡΡΠ°ΠΏΠ°Ρ
ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π°, ΠΈΠ·ΡΡΠ΅Π½ΠΈΠ΅ Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΠΈ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΠΌΠΎΠ»Π΅ΠΊΡΠ»ΡΡΠ½ΠΎ-Π³Π΅Π½Π΅ΡΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ² Π΄Π»Ρ ΠΏΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π΅Π½ΠΈΡ ΠΏΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΠΈ ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΡΡΠ°ΠΌΠΌΠ° Π² Π³ΠΎΡΠΎΠ²ΠΎΠΉ ΡΠΎΡΠΌΠ΅ Π²Π°ΠΊΡΠΈΠ½Ρ ΠΈ ΠΈΠ·ΡΡΠ΅Π½ΠΈΠ΅ Π½ΡΠΊΠ»Π΅ΠΎΡΠΈΠ΄Π½ΠΎΠΉ ΠΏΠΎΡΠ»Π΅Π΄ΠΎΠ²Π°ΡΠ΅Π»ΡΠ½ΠΎΡΡΠΈ ΡΡΠ°ΠΌΠΌΠ° CVS.ΠΠ°ΡΠ΅ΡΠΈΠ°Π»Ρ ΠΈ ΠΌΠ΅ΡΠΎΠ΄Ρ: ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½Π½ΡΠΉ ΡΡΠ°ΠΌΠΌ Π²ΠΈΡΡΡΠ° Π±Π΅ΡΠ΅Π½ΡΡΠ²Π° ΠΠ½ΡΠΊΠΎΠ²ΠΎ-32, ΡΠ°Π±ΠΎΡΠΈΠ΅ ΠΏΠΎΡΠ΅Π²Π½ΡΠ΅ Π²ΠΈΡΡΡΡ, Π³ΠΎΡΠΎΠ²ΡΠ΅ ΡΠ΅ΡΠΈΠΈ Π²Π°ΠΊΡΠΈΠ½Ρ Π°Π½ΡΠΈΡΠ°Π±ΠΈΡΠ΅ΡΠΊΠΎΠΉ, ΡΡΠ°ΠΌΠΌ CVS ΡΠΈΠΊΡΠΈΡΠΎΠ²Π°Π½Π½ΠΎΠ³ΠΎ Π²ΠΈΡΡΡΠ° Π±Π΅ΡΠ΅Π½ΡΡΠ²Π°, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΠ΅ΠΌΡΠΉ Π΄Π»Ρ ΠΎΡΠ΅Π½ΠΊΠΈ ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΈΠΌΠΌΡΠ½ΠΈΡΠ΅ΡΠ°. ΠΠΎΠ»Π΅ΠΊΡΠ»ΡΡΠ½ΠΎ-Π³Π΅Π½Π΅ΡΠΈΡΠ΅ΡΠΊΠΎΠ΅ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΎ Ρ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ ΠΠ’-ΠΠ¦Π Ρ ΠΏΠΎΡΠ»Π΅Π΄ΡΡΡΠ΅ΠΉ ΡΠ΅ΡΡΡΠΈΠΊΡΠΈΠ΅ΠΉ ΠΈ ΡΠ΅ΠΊΠ²Π΅Π½ΠΈΡΠΎΠ²Π°Π½ΠΈΠ΅ΠΌ.Π Π΅Π·ΡΠ»ΡΡΠ°ΡΡ: ΠΏΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½Ρ ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΡ Π°Π½Π°Π»ΠΈΠ·Π° Π½ΡΠΊΠ»Π΅ΠΎΡΠΈΠ΄Π½ΡΡ
ΠΏΠΎΡΠ»Π΅Π΄ΠΎΠ²Π°ΡΠ΅Π»ΡΠ½ΠΎΡΡΠ΅ΠΉ ΡΡΠ°Π³ΠΌΠ΅Π½ΡΠ° Π³Π΅Π½Π° G, ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΠΎΠ³ΠΎ ΠΈΠ· ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΡΡΠ°ΠΌΠΌΠ° ΠΠ½ΡΠΊΠΎΠ²ΠΎ-32, ΡΠ΅ΡΠΈΠΉ ΡΠ°Π±ΠΎΡΠ΅Π³ΠΎ ΠΏΠΎΡΠ΅Π²Π½ΠΎΠ³ΠΎ Π²ΠΈΡΡΡΠ° ΠΈ Π³ΠΎΡΠΎΠ²ΡΡ
ΡΠ΅ΡΠΈΠΉ Π²Π°ΠΊΡΠΈΠ½Ρ Π°Π½ΡΠΈΡΠ°Π±ΠΈΡΠ΅ΡΠΊΠΎΠΉ, ΠΈΠ·Π³ΠΎΡΠΎΠ²Π»Π΅Π½Π½ΡΡ
Π² 2012, 2018, 2019 Π³., ΡΡΠ°ΠΌΠΌΠ° ΡΠΈΠΊΡΠΈΡΠΎΠ²Π°Π½Π½ΠΎΠ³ΠΎ Π²ΠΈΡΡΡΠ° Π±Π΅ΡΠ΅Π½ΡΡΠ²Π° CVS, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΠ΅ΠΌΠΎΠ³ΠΎ Π΄Π»Ρ ΠΎΡΠ΅Π½ΠΊΠΈ ΡΠΏΠ΅ΡΠΈΡΠΈΡΠ΅ΡΠΊΠΎΠΉ Π°ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ Π²Π°ΠΊΡΠΈΠ½Ρ. ΠΠΎΠΊΠ°Π·Π°Π½Π° Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΡ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΡΠ΅ΡΡΡΠΈΠΊΡΠΈΠΎΠ½Π½ΠΎΠ³ΠΎ Π°Π½Π°Π»ΠΈΠ·Π° Π΄Π»Ρ ΠΏΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π΅Π½ΠΈΡ ΠΏΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΠΈ ΡΡΠ°ΠΌΠΌΠ° ΠΠ½ΡΠΊΠΎΠ²ΠΎ-32 Π½Π° Π²ΡΠ΅Ρ
ΡΡΠ°ΠΏΠ°Ρ
ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π°, Π²ΠΊΠ»ΡΡΠ°Ρ Π³ΠΎΡΠΎΠ²ΡΡ ΡΠΎΡΠΌΡ Π²Π°ΠΊΡΠΈΠ½Ρ.ΠΠ°ΠΊΠ»ΡΡΠ΅Π½ΠΈΠ΅: ΡΡΠ°ΠΌΠΌΡ ΠΠ½ΡΠΊΠΎΠ²ΠΎ-32 ΠΈ CVS, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΠ΅ΠΌΡΠ΅ Π² Π€ΠΠΠΠ£ Β«Π€ΠΠ¦ΠΠ ΠΠ ΠΈΠΌ. Π. Π. Π§ΡΠΌΠ°ΠΊΠΎΠ²Π° Π ΠΠΒ», ΡΠ²Π»ΡΡΡΡΡ Π²ΠΈΡΡΡΠ°ΠΌΠΈ Π±Π΅ΡΠ΅Π½ΡΡΠ²Π°. ΠΠ½Π°Π»ΠΈΠ· Π½ΡΠΊΠ»Π΅ΠΎΡΠΈΠ΄Π½ΠΎΠΉ ΠΏΠΎΡΠ»Π΅Π΄ΠΎΠ²Π°ΡΠ΅Π»ΡΠ½ΠΎΡΡΠΈ ΡΡΠ°Π³ΠΌΠ΅Π½ΡΠ° Π³Π΅Π½Π° G ΠΏΠΎΠΊΠ°Π·Π°Π», ΡΡΠΎ ΡΡΠ°ΠΌΠΌ ΠΠ½ΡΠΊΠΎΠ²ΠΎ-32 ΡΡΠ°Π±ΠΈΠ»Π΅Π½ Π½Π° ΡΠ°Π·Π½ΡΡ
ΡΡΠ°ΠΏΠ°Ρ
ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π°. ΠΠΎΠ»ΡΡΠ΅Π½Π½Π°Ρ Π½ΡΠΊΠ»Π΅ΠΎΡΠΈΠ΄Π½Π°Ρ ΠΏΠΎΡΠ»Π΅Π΄ΠΎΠ²Π°ΡΠ΅Π»ΡΠ½ΠΎΡΡΡ Π³Π΅Π½Π° G ΡΡΠ°ΠΌΠΌΠ° ΠΠ½ΡΠΊΠΎΠ²ΠΎ-32 Π΄Π΅ΠΏΠΎΠ½ΠΈΡΠΎΠ²Π°Π½Π° Π² GenBank (Π½ΠΎΠΌΠ΅Ρ MN116503). ΠΠΎΠΊΠ°Π·Π°Π½Π° Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΡ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΡ ΡΠ΅ΡΡΡΠΈΠΊΡΠΈΠΎΠ½Π½ΠΎΠ³ΠΎ Π°Π½Π°Π»ΠΈΠ·Π° Π΄Π»Ρ ΠΏΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π΅Π½ΠΈΡ ΠΏΠΎΠ΄Π»ΠΈΠ½Π½ΠΎΡΡΠΈ ΡΡΠ°ΠΌΠΌΠ° ΠΠ½ΡΠΊΠΎΠ²ΠΎ-32 Π²ΠΈΡΡΡΠ° Π±Π΅ΡΠ΅Π½ΡΡΠ²Π° Π½Π° Π²ΡΠ΅Ρ
ΡΡΠ°ΠΏΠ°Ρ
ΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΡΡΠ²Π°, Π²ΠΊΠ»ΡΡΠ°Ρ Π³ΠΎΡΠΎΠ²ΡΡ ΡΠΎΡΠΌΡ Π²Π°ΠΊΡΠΈΠ½Ρ
Analysis of Batch to Batch Consistency of a Locally Produced Influenza Vaccine for the 2017β2018 Influenza Season
The efficacy of influenza vaccines has been a matter of considerable debate ever since the development of theΒ first influenza vaccine. The efficacy of currently used influenza vaccines depends on manyΒ factors, including theΒ strain composition, the degree of homologyΒ between the produced and epidemic influenza viruses, theΒ vaccinationΒ coverage, and many other factors. Assessment of quality, i.e. determination of compliance of the productβsΒ qualityΒ characteristics with the specification requirements, and assessmentΒ of risks associated with the use of theΒ product were considered onlyΒ in the context of general requirements for the quality of biologicals.Β The article summarisesΒ the results of analysis of batch to batchΒ consistency of the influenza inactivated polymer-subunit vaccine.Β The study included a retrospective assessment of the dataΒ obtained during the product release control and testingΒ performed by an accredited testing centre as part of mandatory certification. TheΒ data obtained may be used toΒ improve the production method andΒ the system of statistical management of the production process, asΒ well as toΒ assess the risks accompanying the production of influenza vaccine at each of the stages
Genome-Editing and Biomedical Cell Products: Current State, Safety and Efficacy
Advances in ex vivo technologies of human genome editing have made it possible to develop new approaches to the treatment of genetic, oncological, infectious and other diseases, which may involve the use of biomedical cell products. However, despite the rapid development of these technologies and a large number of clinical trials conducted in many countries around the world, only 4 products (Strimvelis, Zalmoxis, Kymriah and Yescarta) containing ex vivo genetically modified human cells are authorised for use in the European Union and the United States of America. This paper considers three promising technologies (ZFN, TALEN and CRISPR) that allow for easy and effective editing of the genome at the sites of interest, thereby creating a platform for further development of the genetic engineering of human cells. It describes the technology of engineering chimeric antigen receptors (CARs). It also provides data on the efficacy and safety of the approved products: Strimvelis which contains autologous CD34+ cells transduced ex vivo with a retroviral vector containing adenosine deaminase gene, Zalmoxis which contains modified allogeneic T-cells, and two products: Kymriah and Yescarta which contain autologous T-cells with CARs to CD19 antigen, intended for the treatment of CD19+ hematological malignancies
Molecular Genetic Testing of Stability and Identification of Vnukovo-32 Strain Used for Production of the Cultural Concentrated Purified Inactivated Dry Rabies Vaccine
Rabies is an acute viral disease caused by a virus of the Rhabdoviridae family of the Lyssavirus genus, which affects the central nervous system and is characterised by absolute mortality. Vaccination is the only way to prevent the disease in humans. One of the products used for vaccination is a cultural concentrated purified inactivated dry rabies vaccine produced by the Federal State Budgetary Institution of Science βChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciencesβ (hereinafterβChumakov Center).The aim of the study was to examine the structure of the working virus seed of Vnukovo-32 strain used by the Chumakov Center for rabies vaccine production, to assess its genetic stability during production, to explore the possibility of using molecular genetic methods for identification of the production strain in the finished dosage form, and to study the nucleotide sequence of the CVS strain.Materials and methods: Vnukovo-32 rabies virus production strain, working virus seeds, finished batches of the rabies vaccine, CVS fixed rabies virus strain used in the assessment of specific immunity. The molecular genetic study was performed using RT-PCR followed by restriction and sequencing.Results: the paper presents the results of nucleotide sequence analysis of the G gene fragment obtained from the Vnukovo-32 production strain, batches of the working virus seed, and finished batches of the rabies vaccine produced in 2012, 2018, and 2019, and the CVS fixed rabies virus strain used in the assessment of the vaccineβs specific immunity. The study demonstrated that restriction analysis could be used for Vnukovo-32 strain identification at all production stages, including the finished dosage form.Conclusion: Vnukovo-32 and CVS strains used by the Chumakov Center are rabies viruses. Analysis of the nucleotide sequence of the G gene fragment showed that the Vnukovo-32 strain remains stable throughout different production stages. The obtained nucleotide sequence of gene G of the Vnukovo-32 strain was deposited in GenBank (accession number MN116503). The study demonstrated that restriction analysis could be used for Vnukovo-32 strain identification at all production stages, including the finished dosage form