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N. N. Ugarova, G. Yu. Lomakina, T. A. Perevyshina, E. V. Otrashevskaya, S. V. Chernikov

In process control of BCG vaccine cell viability by bioluminescent ATP assay

Abstract

The BCG vaccine based on a live strain of Mycobacterium bovis BCG is widely used for the immunoprophylaxis of tuberculosis. One of the BCG vaccine key parameters is its cell viability (specific activity the number of colony forming units, CFU ), which is traditionally defined by microbiological method. In this work, the rapid and selective bioluminescent method of intracellular ATP assay was used to control the BCG vaccine viability at various stages of the vaccine production. It permitted to reduce the analysis time from 28 days up to 1 hour. The correlation was shown between the viability of liquid BCG vaccine, measured by microbiological method and calculated using the content of intracellular ATP, as well as the correlation between the CFU value for the lyophilized BCG vaccine and the ATP content in liquid vaccine before lyophilization.
Key words: BCG vaccine, ATP assay, cell viability, tuberculosis, colony forming units (CFU)
Moscow University Chemistry Bulletin.
2019, Vol. 60, No. 4, P. 254
   

Copyright (C) Chemistry Dept., Moscow State University, 2002
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