AustinPx KinetiSol Earns FDA AMT Designation

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) has granted Advanced Manufacturing Technology (AMT) designation to AustinPx’s KinetiSol Technology, a solvent-free technology for producing amorphous solid dispersions of poorly soluble oral drug candidates.

KinetiSol can be used from early development through commercial manufacturing and expands the options available for molecules that can be difficult to address with conventional ASD technologies.

“Drug developers shouldn’t have to choose between the manufacturing technology that best fits the molecule and the one with the most familiar regulatory path,” said Elizabeth Hickman, CEO of AustinPx. “Awarded based on the FDA’s comprehensive review of the KinetiSol Technology, the AMT designation provides our clients with greater confidence in the regulatory path to commercializing their KinetiSol-enabled drug candidates.”

For sponsors using KinetiSol as the amorphous dispersion manufacturing process for clinical candidates, the designation provides opportunities for earlier FDA engagement and additional communication during drug development and application assessment. This can help sponsors address Chemistry, Manufacturing and Controls (CMC) questions sooner, reduce regulatory uncertainty and plan more efficiently as their programs move toward commercial manufacturing.

Chris Brough, Ph.D., Chief Technology Officer and co-inventor of KinetiSol, said, “As more of our clients advance their KinetiSol-formulated candidates into late-phase development and toward commercialization, the FDA’s recognition reinforces KinetiSol’s value as a commercial manufacturing technology.”

In June, AustinPx agreed to install KinetiSol at Thermo Fisher’s Bend, Oregon, and Cincinnati, Ohio, oral solid drug manufacturing sites.