To expedite the process of developing materials for clinical trials, IPM built a state-of-the-art manufacturing facility in Bethlehem, Pennsylvania, in 2005. The facility is a significant new tool in its microbicide development strategy and is a resource available to microbicide developers around the world.

In the past, microbicide researchers have had very limited options for outsourcing the production of materials for clinical trials to facilities not specialized in microbicide manufacturing – a costly and time-intensive step which delayed research and development efforts. IPM’s decision to invest in the Bethlehem-based facility was rooted in a deep understanding of these obstacles and a firm determination to overcome them.

With newly added manufacturing capacity, IPM can now expedite the production of microbicide drugs for expanded safety trials. The facility has the capacity to fill applicators (the standard method for vaginal delivery of a microbicide gel) and to complete packaging appropriate for clinical trials. The facility can produce two- to 20-kilogram batches of topical microbicide gels, lotions and creams for safety trials, equalling approximately 500 to 6,000 individual-use product units.

IPM’s production process follows the internationally accepted guidelines known as Good Manufacturing Practices (GMP). These guidelines were established primarily to ensure the safety of trial participants and are designed to systematize every aspect of manufacturing so that the concentration, formulation and other physical and chemical characteristics of each drug batch are identical. The manufacturing facility also meets all regulatory requirements.

To date, numerous batches of placebo and dapivirine (TMC120 gel) have been produced and shipped to trial sites around the world for use in safety and expanded safety clinical trials.

>> Read article on “Manufacturing Microbicides” from Impact 10: HIV Prevention – Condoms and Beyond