Quality Control Testing of BCG Vaccine: Current Practices and Technological Advancements

The Bacille Calmette-Guérin (BCG) is live and attenuated strain of Mycobacterium bovis which is used throughout the world as vaccine against tuberculosis. BCG vaccination contributes to the prevention and control of tuberculosis in limited situations when other strategies are inadequate. As there is currently no alternative, BCG will continue to be used in future as vaccine and also as a prime vaccine in a primeboost immunization in conjunction with new tuberculosis vaccines. Therefore, there is need to improve the characterization and the assays used for the quality control of BCG vaccine. In this article, we present the recent technological advancements in the quality control testing of BCG vaccine. Special attention has been given to the newly developed methods for the identification and potency testing of BCG taking into account the recent advancements in genetics and molecular biology.