This project is focused on the development of a novel transgenic avian production platform that will provide human therapeutics in a rapid, cost-effective fashion. Specifically, we intend to create transgenic Japanese quail (Coturnix Coturnix sp. japonica) that produce humanized monoclonal antibody (huMAb) within the albumen (white) portion of their laid eggs. The anticipated demand for therapeutic huMAbs will require a production capacity greater than what is currently available in the worldwide industry. The rapid onset of sexual maturity in quail will result in the production of huMAb in a fourth of the time required by other transgenic platforms (e.g., chickens, mammals and plants). The primary goal of Phase I is to produce huMAb in quail egg white in sufficient quantities for subsequent detailed characterization. This will be accomplished by first identifying DNA constructs that express huMAb in vitro in a cell specific manner. Transgenic G1 hens will be generated to produce huMAb in quantities sufficient for glycosylation and avidity analyses to be initiated in Phase II of the project. Phase II will conclude with the production of a transgenic flock capable of generating quantities of huMAb required for clinical trials. The development of quail as a bioreactor platform will decrease the time required to evaluate potential huMAb therapeutics and other biologics.