- The FDA has granted Advanced Manufacturing Technology designation to AustinPx’s KinetiSol Technology.
- The designation is intended to support sponsors using KinetiSol as an amorphous dispersion manufacturing process for clinical and commercial drug candidates.
AustinPx has received Advanced Manufacturing Technology (AMT) designation from the US Food and Drug Administration (FDA) for its KinetiSol Technology. The designation is part of the FDA’s Advanced Manufacturing Technologies Designation Program, established under Section 506L of the Federal Food, Drug, and Cosmetic Act.
The FDA’s AMT Designation Program is intended to encourage early adoption of advanced manufacturing methods that can improve drug quality, reduce supply chain vulnerabilities, and prevent or address critical medicine shortages. Under the program, the FDA facilitates development and expedites assessment of applications that use a designated technology.
For sponsors using KinetiSol as an amorphous dispersion manufacturing process for clinical and commercial candidates, the designation is intended to reduce some of the risks associated with adopting a new manufacturing technology. Sponsors referencing KinetiSol’s AMT designation can receive access to early and intensive FDA interactions related to chemistry, manufacturing, and controls (CMC), including specialized meetings and advice on potential process-integration issues.
The designation is also intended to provide greater certainty around technology transfer and the data needed to support a novel manufacturing process during drug approval. AustinPx said the designation may also provide strategic regulatory review advantages for drugs using expedited development pathways, such as Breakthrough Therapy or Fast Track, or for products addressing a critical shortage.
AustinPx said the designation is intended to help address key CMC topics earlier in development and support more efficient drug development and time-to-market timelines. The company added that it hopes the designation will give clients greater confidence in incorporating KinetiSol into their long-term development strategies.
