Automation of GMP manufacturing of HIV microbicide rings

点击翻译按钮获取中文摘要

 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.