Comparison of Lowenstein Jensen Media and Ogawa Media Usage for Viability Test of BCG Vaccine Pasteur P11732 and Russian (Moscow) – 384 sub-strains

Document Type : Short Communication

Author

National Quality Control Laboratory of Drug and Food (NQCLDF), Indonesian FDA, Central Jakarta, Indonesia

10.32592/ARI.2024.79.1.240

Abstract

BCG vaccines on the market have employed a Mycobacterium bovis sub-strains derived from the initial strain. To date, there has been no recommendation regarding the sub-strains with the highest effectiveness when administered to humans. Because it remains the standard for Tuberculosis treatment, the BCG vaccine's quality must be verified. One of the parameters for BCG vaccine quality control is the test for viability. The culture method has become the gold standard for viability testing with various testing media. This study aims to evaluate the performance of Lowenstein Jensen and Ogawa media for the viability test of Pasteur 1173P2 and Russian (Moscow) – 384 sub-strains of M. bovis in the BCG vaccine. The number of culturable particles of each sub-strain in the BCG vaccine was estimated and statistically evaluated using the t-test. The Colonies of the Pasteur 1173P2 has characteristics; tended to clump on both mediums with tiny, rough, and pale yellow/cream colors. While the colony character of the Russian (Moscow) – 384 generally has similar feature but did not cluster and had a smooth texture. In terms of growth rate, Lowenstein Jensen and Ogawa media performed similarly for Pasteur 1173P2 and Russian (Moscow) – 384 sub-strains. Maximum growth is reached by week 5. The culturable particles of Pasteur P1173P2 sub-strains did not differ between mediums. Whereas the growth of the Russian (Moscow) - 384 sub-strains was statistically better on Ogawa media. The results of this study reveal that the performance of the media used for determining the number of culturable particles is based on the sub-strains of M. bovis present in the BCG vaccine.

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References

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Archives of Razi Institute
Volume 79, Issue 1
January and February 2024
Pages 240-245

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