In 2012, IPM and MTN will begin long-term safety and efficacy studies of the dapivirine ring, as part of IPM's dapivirine ring licensure program.
These studies are expected to last several years and will require thousands of vaginal rings.
Expanding Manufacturing Capacity
IPM has selected QPharma, a contract developer and pharmaceuticals manufacturer based in Malmö, Sweden, to manufacture dapivirine vaginal rings for the dapivirine ring licensure program.
QPharma has more than 35 years manufacturing experience and capability to scale up production as needed to supply the clinical studies.
Highly specialized equipment is needed to manufacture our lead formulation.
Because this machinery is not readily available, IPM has purchased it for our manufacturing partner and it has been installed at QPharma’s site.
Selecting a Manufacturing Partner
IPM’s choice of a manufacturing partner is the culmination of a global search process that involved soliciting proposals, diligent evaluations of costs and capabilities, and site visits.
QPharma will use techniques such as Design of Experiment and related tools to maximize product quality and yield. This will ensure an efficient and reliable supply chain for the research centers conducting IPM’s Phase III program.
Collaborating to Meet Women’s Needs
IPM’s partnering approach to manufacturing also will produce benefits beyond the licensure program.
We believe that collaborating on large-scale manufacturing will be the most efficient and fastest way to make a microbicide available to the women who need it most once our product has been shown to be safe and effective in preventing HIV infection.