New technology will make vaccines quality control in Russia 300 times faster

Print 02 August 2017
GMP News

National Immunobiological Company (Nacimbio) introduces a new technology to control the quality of anti-TB vaccines that cuts the period of procedure from one month to 1.5 hours. The technology is developed and tested in the Stavropol branch of NPO Microgen, a part of Nacimbio, and will increase the volume and speed of manufacturing BCG and BCG-M vaccines.

“One of the key stages in vaccine quality control is analyzing the number of live tubercle bacilli in the drug. Only viable bacteria determine the activity of the protective reaction of the body. Our method will drastically reduce the duration of control activities and, in the future, will allow to increase the volume of produced medicines,” said Kirill Gaidash, the acting General Director of NPO Microgen.

The technology is based on bioluminescent analysis of the number of viable tubercle bacilli in the vaccine, which are detected with bioluminometer, a special device. It is capable to measure the chemical energy released by living organisms – Mycobacterium bovis – in the form of luminescence resulting from the enzymatic oxidation.

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