The results of certification of Pharmacopoeial standard for smallpox vaccine

Introduction. Pharmacopoeial standard of activity, specificity and necrotic activity is used in testing of for smallpox vaccines. As a part of standard certification, an opportunity of using Pharmacopoeial standard for smallpox vaccine on new cell culture method (in vitro) for testing a new generation of smallpox vaccines was also defined.

The aim – certification of the Pharmacopoeial standard for smallpox vaccine to the main certified characteristics and defining an opportunity for using Pharmacopoeial standard for smallpox vaccine on new cell culture method (in vitro).

Materials and methods. Pharmacopoeial standard for smallpox vaccine (FSO 3.2.00113, series 130406) and pharmacopoeial biological methods described in the State Pharmacopoeia of the Russian Federation (S.Ph), the monograph 3.3.1.0033.15 Smallpox vaccine live were used in the study. For cell culture method, the technique from State Research Centre of Virology and Biotechnology «Vector» of the Federal Service for Surveillance in Consumer Rights Protection and Human Well-being, Novosibirsk Region, Koltsovo, Russian Federation was used. Statistical data were evaluated using Microsoft Excel software.

Results. The Pharmacopoeial standard for smallpox vaccine (FSO 3.2.00113) was certified. The possibility of using a new method of determining specific activity, specificity (identification) using the culture method was confirmed.

Conclusion. Along with the confirmation of certified characteristics, the possibility of using a new methodology for determining specific activity, specificity (identification) using the culture method was confirmed, and the main acceptance criteria were determined.