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）：这项工作的广泛的长期目标是使发展中国家的妇女能够通过使用艾滋病毒杀微生物剂阴道环来保护自己免受艾滋病毒感染。在该项目的第一和第二阶段，我们开发了技术平台，以在我们的“Pod”IVR中提供广泛的抗逆转录病毒药物。我们证实了在绵羊中递送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，以生产足够进行临床试验的cGMP环。在这个IIB阶段计划中，我们建议 发展以成本效益高的方式生产商业批量艾滋病毒杀微生物剂阴道环的能力。吊舱环制造包括3个步骤：毛坯环制造;吊舱生产;和组装。我们已经成功地实现了前两个步骤的自动化，从而具备了商业批量生产的能力。本阶段IIB提案的具体目标是开发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。这一目标的成功实现将使批量生产成为可能，从而使向发展中国家提供具有成本效益的杀微生物剂环成为可能。