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[Experimental evaluation of the biological safety of gene-engineered bacteria using a model strain Bacillus subtilis
V A Beliavskaia1, T A Kashperova, V M Bondarenko
1State Research Center of Virology and Biotechnology Vector, Koltsovo, Novosibirsk Region, Moscow, Russia.
Abstract:
The in vitro and in vivo evaluation of the biological and ecological safety of genetically modified bacteria (GMB) was carried out on B. subtilis recombinant strain 2335/105, capable of producing human interferon alpha-2, used as experimental model. As shown in this investigation made with the use of bacteriological analysis and polymerase chain reaction, the oral administration of GMB to calves, chickens and white mice produced no disturbances in the microbial ecology of the gastrointestinal tract of warm-blooded animals and did not lead to the appearance of spontaneous transformants. The present work is the first experimental evaluation of the biological safety of genetically modified microorganisms, used as the component of Subalin, a probiotic preparation intended for use in veterinary practice.