FDA official outlines emerging technologies program
“I think there’s sometimes a misperception that advanced manufacturing is just continuous manufacturing,” said Welch, who provided an update on ETP at the recent PharmaLink conference hosted by Regulatory Affairs. Professionals Society (RAPS) and Association of Food and Drug Officials (AFDO). He added that “in reality, advanced manufacturing certainly includes continuous manufacturing, but it is much more than that.”
Advanced manufacturing may include new manufacturing methods to improve process robustness, new dosage forms, new modeling tools for analytical testing, and new container closure systems.
ETP has accepted 110 advanced manufacturing proposals since the program’s inception in 2014.
FDA data shows that acceptances into the ETP program cover a wide range of technologies, although continuous manufacturing remains the most common type of technology accepted into the program; 46 were accepted. New analytical technologies represent the second most common technology with 12 applications, followed by new aseptic technologies such as continuous aseptic spray drying systems with 11 applications. Other applications accepted under the program include new dosage forms, 3D printing and new types of container closures, as well as applications involving the manufacture of modular or portable point-of-service.
Although continuous manufacturing requests continue to be the most common type of submission, an increasing number of requests are for new aseptic technologies.
After experiencing a steady increase, the number of FTE acceptances has steadily declined in recent years. There were 24 proposals submitted in 2019, 17 in 2020, 13 in 2021 and six in 2022. Welch attributes the drop to shifting priorities brought about by the pandemic.
Welch also addressed some common questions, such as whether sponsors should wait until a molecule has been developed to apply to participate in the ETP program. He said companies can participate even if they are considering five or six molecules for a new test. “We are happy to engage at this point and provide feedback at this time. What we’ve learned is that early engagement is the hallmark of success.
Sponsors do not have to wait to submit an Investigational New Drug (IND) application to participate in the program. “Wherever you can make the case for an emerging technology, we can meet in that context,” Welch said.
The FDA has been encouraging the adoption of advanced manufacturing for at least a decade. The agency says advanced manufacturing methods can help companies reduce costs and quality defects and can improve the global competitiveness of American manufacturing. (RELATED: FDA officials tout advancements and achievements in advanced manufacturing, Regulatory guidance October 15, 2021)