As part of the collaboration between the US companies, a commercial-scale KinetiSol technology manufacturing line developed by DisperSol is planned to be installed at Catalent’s oral solids development and manufacturing facility in Somerset, New Jersey.

The agreement foresees DisperSol setting up its proprietary equipment, software and knowhow in a dedicated suite at the Somerset facility. Here, the CDMO will provide staff for development, scale-up and commercial stage KinetiSol production, as well as associated capabilities including process engineering, Quality Control and Assurance.

“This strategic collaboration with Catalent is integral to our company as we now move into late clinical-stage development and commercial-scale manufacturing of our products,” said DisperSol CEO Edward M. Rudnic. “The commercial amorphous solid dispersion manufacturing expertise of Catalent’s team and their globally accredited quality systems make them a perfect partner for DisperSol,” he added.

KinetiSol’s platform is a disruptive innovation in amorphous solid dispersion manufacturing owned by DisperSol, and the company said is “is often the best and sometimes the only method to turn molecules with great clinical promise but poor bioavailability into viable medicines for patients.”  The technology underlies all of DisperSol’s pipeline programs including Phase 3 ready KDFX for iron overload disorder and KABE, which recently began Phase 2 studies against prostate cancer.

Jeremie Trochu, vice president, operations, Early Phase Development, at Catalent, said the company’s Somerset development center has a track record of introducing and industrializing new oral technologies such as the KinetiSol platform.

Author: Dede Williams, Freelance Journalist