Automation of GMP manufacturing of HIV microbicide rings

HIV 杀菌剂环 GMP 生产自动化

• 批准号: 8993538
• 负责人: Thomas J. Smith
• 金额: $ 33.74万
• 依托单位: AURITEC PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8993538
• 关键词: Adherence; Agreement; Animals; Antiviral Agents; Automation; Chemistry; Clinical; Clinical Trials; Collaborations; Cyclic GMP; Development; Devices; Drug Delivery Systems; Drug Formulations; Drug Kinetics; Engineering; Environment; Equipment; FDA approved; Feasibility Studies; Gel; Goals; HIV; HIV Infections; Hormones; Human; Infection; Infection prevention; Licensing; Macaca; Marketing; Methods; Modeling; Oryctolagus cuniculus; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Pilot Projects; Process; Production; Prophylactic treatment; Qualifying; Research Personnel; Safety; Sheep; Simplexvirus; Solubility; System; Technology; Tenofovir; Testing; Vaginal Ring; Validation; Woman; Work; aqueous; base; cGMP production; controlled release; cost effective; design; drug development; empowered; experience; innovation; lot production; manufacturing process; material transfer agreement; microbicide; programs; public health relevance

 DESCRIPTION (provided by applicant): The broad long term goal of this work is to empower women in the developing world to protect themselves against HIV infection through the use of an HIV microbicide intravaginal ring. In Phase I and II of this project we developed the technology platform to deliver a broad range of antiretrovirals in our "Pod" IVRs. We confirmed the safety and pharmacokinetics of delivery in sheep and the ability of these rings to prevent infection in the macaque model. We also developed manufacturing methods to produce cGMP rings at a volume sufficient for carrying out clinical trials. In this Phase IIB program we propose to develop the capacity for cost effective manufacture of commercial lots of HIV microbicide intravaginal rings. Pod ring manufacture comprises 3 steps: blank ring manufacture; pod production; and assembly. We have successfully automated the first two steps to have the capacity for commercial lot production. The specific aim of this Phase IIB proposal is to develop and implement an automated assembly and packaging strategy. Our approach will comprise pilot and feasibility studies in the first year and transfer to cGMP in the second year. The successful completion of this aim will allow commercial lot manufacture which will allow cost-effective provision of microbicide rings to the developing world.

 描述（由申请人提供）：这项工作的广泛长期目标是使发展中国家的妇女能够通过使用阴道内的艾滋病毒杀微生物剂来保护自己免受艾滋病毒感染。在该项目的第一阶段和第二阶段，我们开发了我们在“Pod”IVR 中提供了多种抗逆转录病毒药物的技术平台，我们确认了这些环在绵羊中的安全性和药代动力学，以及这些环在猕猴模型中预防感染的能力。我们还开发了生产方法。 cGMP 的数量足以进行临床试验，我们建议在此 IIB 期计划中。 开发具有成本效益的批量生产 HIV 杀菌剂阴道环的能力，包括 3 个步骤：毛坯环生产；我们已成功实现前两个步骤的自动化，从而具备商业批量生产的能力。该IIB阶段提案的具体目标是制定和实施自动化组装和包装策略，我们的方法将包括第一年的试点和可行性研究，并在第二年转移到cGMP，以便成功完成这一目标。商业批量生产将允许向发展中国家提供具有成本效益的杀微生物剂环。