Bacteria and fungi have been genetically modified to produce recombinant proteins, vaccines, pharmaceuticals, materials, fuels, etc. Finally, the reconstructed organisms will be put to large-scale or industry productions. What is the main concern during the process of developing a commercially useful organism? From the very beginning (choosing target products, genetic modification, etc) to the very end (fermentation, product isolation, etc).
It should not revert back and the yield should be maximum when compared to reported yield,economics of scale is also matters.
No reversion on repeated subcultures( roughly equals the no of multiplications bacteria will undergo during large scale growth), constancy of yield ( or what ever u targeting at), non formation of toxic material during growth, ease of identification of bacteria as well as bi products, environmental safety are some important aspects to be thought off.
If the gene of interest is incorporated/integrated in the genome of the organism and it is not functionally compromised then one can achieve the expected yield constantly to certain extent, but the gene of interest in the plasmid system for example in bacteria then there is a chance of losing the plasmid system carrying the transformed gene in the long run.
Genetically engineered organism first to be tested for its pathogencity (environmental concern), later on scale up, patent for commercial aspects should be considered.......
Industry is a big arena. So, when you think to run genetically modified microorganisms in Industry, firstly check it in small scale production i.e when you will decide, you culture microorganisms 1000 litre, firstly culture 100 litre. If it is successfull, then you culture in large scale. You also need to check media conditions and others.
I think each country has a some regulations for testing of genetically engineered cells. Before reaching to the scale up step and marketing and so on , there are lots of steps that should be checked. In reality, most of the Genetically modified cells have remain just in papers without any further usage.
Pay attention to the safety record of the host production organism; if it is known as an opportunistic pathogen, it will have a much harder time getting regulatory approval. Also consider how it would be inactivated after a fermentation run; if it is easily pasteurized/inactivated this will mean reduced costs for industry and more easy acceptance by regulators.
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