AustinPx has received Advanced Manufacturing Technology (AMT) designation from the U.S. Food and Drug Administration (FDA) for its KinetiSol™ Technology, a solvent-free manufacturing process designed to produce amorphous solid dispersions (ASDs) for poorly soluble oral drug candidates.

The designation was granted by the FDA’s Center for Drug Evaluation and Research (CDER) and could provide drug developers using KinetiSol with additional opportunities for regulatory interaction as their programs progress through development and toward commercialization.

KinetiSol is intended to address one of the recurring challenges in oral drug development: improving the solubility and bioavailability of compounds that perform poorly in conventional formulations. The technology can be applied from early-stage development through commercial manufacturing, according to AustinPx.

The FDA’s AMT Designation Program was established to support the adoption of innovative manufacturing approaches that have the potential to improve product quality, shorten development timelines, strengthen manufacturing supply chains and help mitigate drug shortages.

For sponsors incorporating KinetiSol into the manufacturing strategy for clinical candidates, the designation may facilitate earlier discussions with the FDA and additional communication during development and application review. AustinPx said these interactions could help companies address chemistry, manufacturing and controls (CMC) considerations earlier and reduce uncertainty as programs advance.

“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,” says 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.”

AustinPx has been developing KinetiSol for more than 15 years and says the platform has been applied to more than 70 poorly soluble molecules. The company views the FDA designation as particularly relevant as KinetiSol-based drug candidates move into later-stage clinical development and commercial manufacturing.

The AMT designation does not itself constitute FDA approval of any drug product manufactured using KinetiSol. Rather, the program is intended to provide a framework for regulatory engagement around qualifying manufacturing technologies as drug developers advance their individual products.

For more information, visit www.austinpx.com/amt-designation.