FDA’s Joel Welch, Pfizer’s Connie Langer and Lisa Skeens

The US Food and Drug Administration (FDA) accepts a wide variety of applications into its Emerging Technologies Program (ETP), and is not just focused on continuous manufacturing, said Joel Welch, associate director for science and biosimilar strategy in the agency’s Office of Biotechnology Products.
“I think that sometimes there is a misperception that advanced manufacturing is just about continuous manufacturing,” said Welch who provided an update on the ETP at the recent PharmaLink conference hosted by the Regulatory Affairs Professionals Society (RAPS) and the Association of Food and Drug Officials (AFDO). He added that, “In reality, advanced manufacturing certainly includes continuous manufacturing, but it is much more than just that.”
Advanced manufacturing can include novel manufacturing methods to improve process robustness, novel dosage forms, new modeling tools for analytical testing and novel container closure systems.
The ETP has accepted 110 advanced manufacturing proposals since the program’s inception in 2014.
FDA data shows that acceptances into the ETP program span a wide range of technologies, though continuous manufacturing remains the most common type of technology accepted to the program; 46 have been accepted. Novel analytical technologies represent the next most common technology with 12 applications, followed by new aseptic technologies such as systems for continuous aseptic spray drying with 11 applications. Other applications accepted to the program include novel dosage forms, 3D printing and new types of container closures, as well as applications that involve modular or portable point of care manufacturing.
While continuous manufacturing applications continue to be the most common submission type, an increasing number of applications are for novel aseptic technologies.
After experiencing a steady increase, the number of ETP acceptances has steadily decreased 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 wrought by the pandemic.
Welch also addressed some common questions, such as whether sponsors must wait until a molecule has been developed to request participating in the ETP program. He said companies can participate even if they are considering five or six molecules for a new assay. “We are happy to engage at that point and provide feedback then. What we learned is that early engagement is the hallmark to success.”
Sponsors do not have to wait until they have submitted an investigational new drug application (IND) to participate in the program. “Wherever you can make the case for an emerging technology, we can meet in that context,” Welch said.
FDA has encouraged the adoption of advanced manufacturing for at least a decade. The agency claims that advanced manufacturing methods can help companies reduce costs and quality defects and can improve global competitiveness of US manufacturing. (RELATED: FDA officials tout progress and achievements in advanced manufacturing, Regulatory Focus 15 October 2021)
AFDO/RAPS meeting


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