GEORGETOWN, Texas — September 15, 2026
AustinPx announced that the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has granted Advanced Manufacturing Technology (AMT) designation to KinetiSol™ Technology, the company’s solvent-free platform for manufacturing amorphous solid dispersions (ASDs) of poorly soluble oral drug candidates. The designation is intended to support earlier engagement between FDA and sponsors using innovative manufacturing technologies and provide additional regulatory communication during drug development and application review. AustinPx said the designation may help sponsors address Chemistry, Manufacturing and Controls (CMC) considerations earlier and improve regulatory planning as KinetiSol-enabled drug candidates advance toward commercialization.
KinetiSol Targets Poorly Soluble Oral Drug Candidates
KinetiSol is a solvent-free technology designed to produce amorphous solid dispersions for poorly soluble small-molecule drug candidates. The platform can be applied from early development through commercial manufacturing and is intended to provide an alternative for molecules that may be challenging to formulate using conventional amorphous dispersion technologies. AustinPx said KinetiSol has been developed for more than 15 years and has been applied to more than 70 poorly soluble molecules. By enabling formulation and manufacturing development around poorly soluble compounds, the technology is positioned to support bioavailability enhancement and phase-appropriate development strategies for pharmaceutical and biotechnology sponsors.
FDA AMT Program Supports Earlier Regulatory Engagement
The FDA established the Advanced Manufacturing Technology Designation Program to encourage adoption of innovative manufacturing technologies that can improve product quality, reduce development timelines, strengthen supply reliability and potentially help prevent or address critical drug shortages. For sponsors using KinetiSol as the manufacturing process for amorphous solid dispersions, the designation creates opportunities for earlier FDA engagement and additional communication during development and application assessment. AustinPx said this interaction can help sponsors identify and address CMC questions sooner, potentially reducing regulatory uncertainty and improving planning as programs progress from clinical development toward commercial manufacturing.
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AustinPx Advances KinetiSol Toward Commercial Manufacturing
The AMT designation comes as AustinPx clients advance KinetiSol-formulated candidates into later-stage development and toward commercialization. As a CDMO, AustinPx provides formulation and analytical development services together with cGMP manufacturing for small-molecule medicines, with a focus on poorly soluble compounds and bioavailability enhancement. The FDA designation does not constitute approval of any individual drug candidate manufactured using KinetiSol, but instead recognizes the manufacturing technology within the agency’s AMT framework. The designation provides a regulatory pathway for continued interaction around KinetiSol as sponsors progress their individual programs and supports the company’s efforts to establish the platform as a manufacturing option from development through commercial supply.
Source :AustinPx press release
