SBIR Phase I: Enhanced delivery of bioactive compounds for aquaculture

该小企业创新研究第一阶段项目的更广泛影响/商业潜力将是提高水产养殖鱼类和贝类的可用性，同时改善在集约化管理下生长时的福利。 由于多种因素，生物活性化合物或生物制品（例如疫苗、药物和营养制品）的口服输送在水产养殖中具有挑战性：1）制造过程中的热损伤，2）饲料在储存过程中经常面临高温和潮湿，从而降低其生物活性，3）材料在水中输送，4）材料必须通过胃肠道中的挑战性条件，然后定位效应位点。 该项目开发口服递送和保护生物活性化合物和生物制剂活性的制剂和方法，用于保护动物免受疾病侵害。该项目开发的方法将减少提供保护所需的这些材料的数量。由于生物活性化合物和生物制品是高成本材料，使用大量减少的材料提供相同的活性将降低其在水产养殖中的使用成本。由于这些高价值化合物的应用更加经济实惠，可以更有效地控制水产养殖中的病原体并改善动物健康，从而提高水产养殖的可持续性。在这些配方中成功使用更实惠的生物制品将促进水产养殖生产，从而减少世界对野生捕捞渔业的依赖。该第一阶段研究项目的技术目标集中于开发口服递送制剂和方法，以改善寡核糖核苷酸、多糖和蛋白质的递送，这些制剂和方法可应用于对水产养殖业具有商业重要性的其他生物活性化合物和生物制剂。由于制造、储存和运输过程中的高湿度条件，水产养殖为有效提供高成本的生物制品和生物活性化合物提供了一个困难的环境。在第一阶段，该项目的重点将是优化专有递送配方的成分，以提高和验证其保护和递送不同类别化合物（寡糖核苷酸、多糖和蛋白质）的能力。成功的第一阶段将完成递送系统的初步开发，并开始验证两种口服递送产品的免疫刺激能力，这两种口服递送产品基于改进的寡核糖核苷酸和已证明免疫刺激能力的游离β-葡聚糖产品的递送。

The broader impact/commercial potential of this Small Business Innovation Research Phase I project will be to improve the availability of aquaculture-raised fish and shellfish while improving their welfare when grown under intensive management. Oral delivery of bioactive compounds or biologics (such as vaccines, drugs and nutraceuticals) is challenging in aquaculture due to a number of factors: 1) heating damage during manufacturing, 2) feeds often face high temperature and humidity during storage that degrades their biological activity, 3) materials are delivered in water, and 4) materials must pass through challenging conditions in the gastrointestinal tract and then locate effector sites. This project develops formulations and methods to orally deliver and protect the activity of bioactive compounds and biologics, which are used to protect animals from disease. The methods developed in this project will reduce the amount of these materials necessary to provide protection. Since bioactive compounds and biologics are high cost materials, delivery of the same activity using a much reduced amount of the material will lower the cost for their use in aquaculture. More effective control of pathogens and improved animal health in aquaculture due to more affordable application of these high value compounds will improve aquaculture sustainability. Successful deployment of more affordable biologics in these formulations will be a boost to aquacultural production that can decrease the world's reliance on wild-catch fisheries. The technical objectives of this Phase I research project are focused on the development of oral delivery formulations and methods for improved delivery of oligoribonulceotides, polysaccharides and proteins that can be applied to other bioactive compounds and biologics of commercial importance for the aquaculture industry. Aquaculture presents a difficult environment to effectively deliver high cost biologics and bioactive compounds due to the high moisture conditions during manufacture, storage and delivery. During Phase I, the project?s focus will be on optimization of the components of proprietary delivery formulations to improve and validate their ability to protect and deliver different classes of compounds (oligoribonulceotides, polysaccharides, and proteins). A successful Phase I will complete the initial development of the delivery system and begin validation of the immunostimulatory abilities of two oral delivery products based on the improved delivery of oligoribonucleotides and free beta-glucan products that have already demonstrated immunostimulatory ability.