The amorphous solid dispersion manufacturing platform is owned by DisperSol
DisperSol Technologies, a clinical-stage pharmaceutical company developing treatments for oncology and rare diseases, and Catalent, a provider of delivery technologies, development, and manufacturing solutions for the pharmaceutical industry, have announced a strategic manufacturing collaboration to accelerate the development of multiple DisperSol pharmaceutical products. The collaboration will see the installation of a commercial-scale KinetiSol technology manufacturing line at Catalent’s oral solids development and manufacturing facility in Somerset, New Jersey.
The amorphous solid dispersion manufacturing platform is owned by DisperSol. The company claims KinetiSol is “the best and sometimes only method to turn molecules with great clinical promise but poor bioavailability into viable medicines for patients”. It underlies all the company’s pipeline programs including Phase III ready KDFX for iron overload disorder, and KABE, which recently commenced Phase II studies against prostate cancer.
As part of the agreement, the company will tech transfer its proprietary equipment and software to a suite in Catalent’s Somerset facility. In turn, Catalent will provide staff for development, scale up, and commercial stage 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 Dr Edward M. Rudnic, DisperSol’s CEO. “The commercial amorphous solid dispersion manufacturing expertise of Catalent’s team and their globally accredited quality systems make them a perfect partner for DisperSol.”
“Catalent is thrilled to partner with innovators to accelerate development of novel disruptive technologies to scale. Our Somerset development center has a track record of introducing and industrialising new oral technologies such as the KinetiSol platform,” commented Jeremie Trochu, VP, Operations, Early Phase Development at Catalent. “We look forward to working together to accelerate DisperSol’s pipeline of medicines, so that patients can benefit from the wide-ranging treatments that it has developed.”