Development of an effective non-antibiotic dry-off agent for the dairy industry

Intramammary infection (a.k.a., mastitis) is the largest attributable cause of lost productivity, discarded milk, chronic morbidity, and prophylactic antibiotic use in the dairy industry. The majority of new infections are associated with the dry period, during which the udders are temporarily engorged with milk that often leaks from the teat ends. Furthermore, the three major agencies of the U.S. government with responsibilities associated with food safety (USDA, FDA, CDC) have clearly articulated the concern that antibiotic use in agriculture to treat and prevent mastitis, poses threats to food safety, and to the health of agricultural workers. The technology described in this proposal enhances the naturally occurring dry-off signals within the mammary glands, and will reduce the engorgement of the udder, lowering the risk of mastitis. Our development of a rapid dry-off agent is expected to have two salutary effects on animal health: enhance the effectiveness of therapeutic antibiotics used in cows with subclinical mastitis at dry-off, and prevent new infections in cows that enter dry-off without mastitis. The overall objective of this Phase I SBIR project is to continue the development of an effective non-antibiotic dairy cow dry-off formulation. Results from the Phase I SBIR project identified additional candidate compounds with the desired physiological effect. For the Phase II grant, we intend to conduct field studies on a newer, second-generation formulation to begin an iNAD application with the FDA. We predict the second-generation formulation will be economically viable and a more effective formulation. Furthermore, testing of the formulation will identify a target dose for large scale manufacturing efforts.