Inhalable IgG Synthesis For Influenza Immunoprophylaxis

用于流感免疫预防的吸入式 IgG 合成

• 批准号: 6834282
• 负责人: Stephen P Cape
• 金额: $ 9.96万
• 依托单位: AKTIV-DRY, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-02 至 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6834282
• 关键词: antibody; biomaterial development /preparation; chemical stability; circular dichroism; drug delivery systems; drug design /synthesis /production; electron microscopy; enzyme linked immunosorbent assay; fluorescence spectrometry; high performance liquid chromatography; immunoglobulin G; influenza vaccines; infrared spectrometry; particle; physical process; physical property; polymers; slow release drug; surface coating; surfactant

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.

描述（由申请方提供）：本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将通过一种新的专利工艺，即用气泡干燥器（R）（CAN-BD）进行二氧化碳辅助雾化，同时稳定、干燥和微粉化IgG抗体溶液。将确定直径为0.5至5微米的颗粒的合成和包被的最佳操作参数，并通过体外试验测量稳定的IgG颗粒的尺寸分布、特征和抗原结合活性。将测量包被的IgG颗粒的释放率，以加强将微粉化IgG施用于甲型流感激发小鼠肺部的II期体内测试。目的是增加储存稳定性和用含有IgG的单剂量干粉吸入器治疗流感的功效。开发具有高表面积的稳定抗体粉末，其可以在室温下在现场储存数月而无需冷藏，并且可以以活性形式快速再溶解，这是通过常规注射递送的IgG的额外益处。Aktiv-Dry LLC由Sievers教授和Carpenter教授组成，旨在开发并将科罗拉多大学药物生物技术中心的发明推向市场。

项目成果

Preparation of active proteins, vaccines and pharmaceuticals as fine powders using supercritical or near-critical fluids.

• DOI: 10.1007/s11095-008-9575-6
• 发表时间: 2008-09
• 期刊: PHARMACEUTICAL RESEARCH
• 影响因子: 3.7
• 作者: Cape, Stephen P.;Villa, Joseph A.;Huang, Edward T. S.;Yang, Tzung-Horng;Carpenter, John F.;Sievers, Robert E.
• 通讯作者: Sievers, Robert E.