08.03.21
DisperSol Technologies, a clinical-stage pharmaceutical company developing new treatments for oncology and rare diseases, and Catalent, a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, have entered a 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, NJ.
The KinetiSol platform is a disruptive innovation in amorphous solid dispersion manufacturing owned by DisperSol that is often the best and sometimes the only method to turn molecules with great clinical promise but poor bioavailability into viable medicines for patients. KinetiSol technology underlies all of DisperSol’s pipeline programs including Phase 3 ready KDFX for iron overload disorder, and KABE, which recently commenced Phase 2 studies against prostate cancer.
As part of the agreement, DisperSol will tech transfer its proprietary equipment, software and know-how to a dedicated suite in Catalent’s Somerset facility. In turn, Catalent 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 Edward Rudnic, CEO, DisperSol. “The commercial amorphous solid dispersion manufacturing expertise of Catalent’s team and their globally accredited quality systems make them a perfect partner for DisperSol.”
Jeremie Trochu, vice president, operations, early phase development, Catalent, said, “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 industrializing new oral technologies such as the KinetiSol platform. 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.”
The KinetiSol platform is a disruptive innovation in amorphous solid dispersion manufacturing owned by DisperSol that is often the best and sometimes the only method to turn molecules with great clinical promise but poor bioavailability into viable medicines for patients. KinetiSol technology underlies all of DisperSol’s pipeline programs including Phase 3 ready KDFX for iron overload disorder, and KABE, which recently commenced Phase 2 studies against prostate cancer.
As part of the agreement, DisperSol will tech transfer its proprietary equipment, software and know-how to a dedicated suite in Catalent’s Somerset facility. In turn, Catalent 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 Edward Rudnic, CEO, DisperSol. “The commercial amorphous solid dispersion manufacturing expertise of Catalent’s team and their globally accredited quality systems make them a perfect partner for DisperSol.”
Jeremie Trochu, vice president, operations, early phase development, Catalent, said, “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 industrializing new oral technologies such as the KinetiSol platform. 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.”
