Optimizing Manufacturing Efficiency for a Hormone Implant to Facilitate Maturation and Spawning in Fish

Hatchery production is one of the largest costs and restrains to fin fish aquaculture and conservation fisheries, therefore spawning aids are ranked as a high priority drug by the Association of Fish and Wildlife Agencies-Drug Approval Working Group. Project PI has successfully developed and demonstrated superiority of our slow release spawning implants in a large number of fish species and has been able to gain FDA eligibility for Indexing. However, the current manufacturing methodology, while safe and effective, is very labor & time intensive, and therefore a hurdle to scaling. This proposal investigates a new manufacturing technology, innovative for veterinary drugs (including the aquaculture industry) and for our hormone active ingredient. Three research trials must be completed to submit an amendment to our FDA Indexing approvals and for commercialization: (1) demonstrate the manufacturing methodology can produce an analytically stable hormone implant; demonstrate (2) target animal safety and (3) efficacy of the new implant in fish. Target animals safety and efficacy trials will be completed at project PI Live Advantage Bait hatchery, and manufacturing trials and analytics will be completed by an FDA approved facility.