Thursday, October 15, 2015 12:16:32 PM
The organism is the result of genetic engineering whereby they introduced an expression vector containing the gene sequence for beta-galactosidase (the enzyme that hydrolyzes lactose), but more importantly also containing the antibiotic resistance gene for ampicillin resistance (that allows selection of the host cells that retain the vector upon transformation and recovery on selective media).
Question 1. Do they have FDA approval given that this is a 'genetically engineered strain'? (i.e., FDA approval for use in humans given you can do pretty much anything you want in research)
Question 2. Would antibiotic resistance of a human-use antibiotic in the probiotic strain be acceptable to FDA (you have all seen the issues with multi-drug resistant bacteria, no?)?
Patent:
http://manzopharma.com/lacto-relief-for-people-with-la-ctose-intolerance/lacto-relief-patent/
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