The FDA has granted Advanced Manufacturing Technology designation to AustinPx’s KinetiSol™ Technology. The FDA created the Advanced Manufacturing Technologies Designation Program to encourage early adoption of innovative manufacturing methods that improve drug quality, reduce supply chain vulnerabilities, and prevent or address critical medicine shortages.  

What Is FDA's Advanced Manufacturing Technology Designation?

Established under section 506L of the FD&C Act, the AMT Designation Program supports the adoption of advanced manufacturing technologies. FDA will facilitate development and expedite assessment of applications using a designated technology.

What This Means for Eligible Programs: 

For sponsors using KinetiSol as the amorphous dispersion manufacturing process for clinical and commercial candidates, the AMT designation helps mitigate the risk of adopting new advanced technology like KinetiSol. Because FDA has already reviewed and designated KinetiSol™ Technology, sponsors referencing KinetiSol’s AMT designation can expect:

• Priority FDA CMC Interactions: Sponsors gain access to early, intensive interactions with the FDA regarding CMC. This includes specialized meetings and timely advice to resolve potential process-integration issues before they cause delays.
• De-Risked Tech Transfer & Greater Regulatory Certainty: Sponsors face less uncertainty around the utilization of a novel manufacturing process and the data required to generate and defend independently during the drug approval phase.
• Strategic Regulatory Review Advantages: For drugs with expedited pathways (like Breakthrough Therapy or Fast Track) or those that address a critical shortage.

The goal is to support more efficient drug development and time-to-market timelines by addressing key CMC topics earlier.

Through this designation, we hope to provide our clients with greater confidence in incorporating KinetiSol into their long-term development strategy.