In 2012, IPM and its clinical trial partner MTN began long-term safety and efficacy studies of IPM's monthly dapivirine ring, as part of IPM's Dapivirine Ring Licensure Program.
Lasting several years, these parallel Phase III studies require thousands of vaginal rings.
Expanding Manufacturing Capacity
IPM selected QPharma, a contract developer and pharmaceuticals manufacturer with more than 35 years manufacturing experience based in Malmö, Sweden, to produce the thousands of dapivirine vaginal rings needed for the two Phase III clinical trials and several smaller safety studies that comprise IPM’s Dapivirine Ring Licensure Program.
Highly specialized equipment is needed to manufacture the dapivirine ring. Because this machinery is not readily available, IPM purchased it for our manufacturing partner.
In 2014, QPharma completed the ring production for the licensure program.
Selecting a Manufacturing Partner for Scale-Up
In preparation for positive Phase III results, IPM has selected QPharma as its initial launch partner to manufacture the rings that will be used by former participants of the two trials in open-label-studies and pending regulatory approval for broader distribution.
IPM is also engaged in a global search for a manufacturing partner to produce the ring following its potential approval by regulatory authorities. This extensive search process involves proposal solicitations, diligent evaluations of costs and capabilities, and site visits.
To keep costs to women as low as possible, IPM is exploring manufacturing strategies that would enable higher yields, such as increasing automation and adding equipment that could simultaneously produce multiple batches of rings.
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 timely 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.