Inhalable IgG Synthesis For Influenza Immunoprophylaxis

描述（由申请人提供）：该I期SBIR提案是开发用于免疫预防甲型流感（C类优先病原体）的可吸入IgG微粒的第一步。在第一阶段，Aktiv-Dry将通过一项新专利工艺，二氧化碳辅助雾化与气泡干燥器(R) （CAN-BD）同时稳定，干燥和微化IgG抗体溶液。确定直径0.5 ~ 5微米颗粒的合成和包覆的最佳操作参数，并通过体外实验测量稳定的IgG颗粒的大小分布、特性和抗原结合活性。将测量包被的IgG颗粒的释放率，以加强对感染甲型流感的小鼠肺给予微细化IgG的II期体内试验。目的是提高储存稳定性，以及单剂量含有IgG的干粉吸入器治疗流感的疗效。开发具有高表面积的稳定抗体粉末，可以在室温下在野外储存数月而无需冷藏，并且可以快速以活性形式重新溶解，这是常规注射提供IgG的另一个好处。Aktiv-Dry LLC由西弗斯教授和卡彭特教授成立，旨在开发并将科罗拉多大学制药生物技术中心的发明推向市场。

DESCRIPTION (provided by applicant): This Phase I SBIR proposal is the first step in the development of inhalable IgG microparticles for immunoprophylaxis against Influenza A, a category C Priority Pathogen. In Phase I, Aktiv-Dry will simultaneously stabilize, dry, and micronize IgG antibody solutions by a newly patented process, Carbon Dioxide Assisted Nebulization with a Bubble Dryer(R) (CAN-BD). The best operating parameters for the synthesis and coating of particles 0.5 to 5 microns in diameter will be determined and the size distribution, characteristics and antigen binding activity of stabilized IgG particles will be measured by in vitro tests. Release rates of coated IgG particles will be measured in an effort to enhance the Phase II in vivo tests of the administration of micronized IgG to the lungs of mice challenged with influenza A. The goals are to increase storage stability, and efficacy of treatment of influenza with single dose dry powder inhalers containing IgG. Development of stable antibody powders with high surface areas that can be stored for months at room temperature in the field without refrigeration and can rapidly redissolve in active form is an added benefit for IgG delivered by conventional injection. Aktiv-Dry LLC was formed by Prof. Sievers and Prof. Carpenter to develop and carry into the market inventions made at the University of Colorado Center for Pharmaceutical Biotechnology.