State-of-the-Art Manufacturing Facility Launched to Produce Microbicides to Protect Women from HIV
New Facility Will Help Microbicide Developers Produce Products for Upcoming Clinical Trials
Silver Spring, MD – The International Partnership for Microbicides (IPM) today opened a new manufacturing facility in Bethlehem, Pennsylvania, that will produce clinical trial materials for microbicide studies. The IPM Clinical Trial Material Facility is designed for the production of materials to be used in Phase I and Phase II clinical trials. The new facility, operating under good manufacturing practices (GMP), will be used by IPM and other organizations in the microbicide field.
“This facility will speed the day when a microbicide will be available to help millions of women protect themselves from HIV,” said Janet Darbyshire, Director of the London-based Medical Research Council’s clinical trials unit. “With the creation of this GMP facility, IPM strengthens its role as facilitator of microbicide development.”
IPM is a public/private partnership focused on acceleration of microbicides for woman in developing countries. A microbicide is a product, such as a topical gel or a cream that could be applied vaginally to reduce the transmission of HIV during sexual intercourse. With this facility, IPM addresses a significant bottleneck in microbicide development.
“With the dedication of this facility, the microbicide field has surmounted another hurdle,” said Dr. Zeda Rosenberg, IPM’s Chief Executive Officer. “Through research into formulation and drug delivery systems, and now with the opening of this facility, IPM will be able to produce microbicides at low cost for use in clinical trials.”
In addition to this new manufacturing facility, IPM works with Particle Sciences, Inc., a formulation facility also located in Bethlehem, to conduct research on optimal microbicide formulations. IPM will continue to work with Particle Sciences to formulate promising drug candidates for assembly and packaging at IPM’s new clinical trial material facility.
About IPM
IPM was established in 2002 to prevent HIV transmission by accelerating the development and accessibility of microbicides for use by women in developing countries. The organization's goal is to improve the efficiency of all efforts to deliver a safe and effective microbicide as soon as possible.