Utilizing the Bladder

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Summary A method has been developed to produce a recombinant protein in the urine of a transgenic animal. Such animals are created by using a vector comprised of a urothelial promoter capable of directing urothelial expression of a heterologous gene. Urothelial cells (the lining of the bladder) of such transgenic animals secrete the encoded recombinant protein into the urine for isolation. Thus an animal’s bladder can be transformed into a bioreactor for the selected protein products (e.g.,therapeutics, anti-bodies, antigens). Advantages Both male and female animals can be productive throughout their lives, not just female animals that are lactating. The use of urine, which contains relatively little protein and lipid, as a starting material facilitates purification of recombinant proteins. In addition, urothelial cells have the potential to produce certain recombinant proteins with specific posttranslational modifications, such as glycosylation or proteolytic processing, that may not occur properly in mammary or other bioreactor systems, yet are necessary for biological activity. Application Cost effective production of all biologically active proteins.