A nonprofit organization is working to help U.S. drug manufacturers adopt advanced production technologies by addressing the high upfront costs, according to a March 10 report. The API Innovation Center (APIIC) is using a mix of state, federal, philanthropic, and private-sector funding to support the shift from traditional batch manufacturing to continuous manufacturing processes.
The move comes as policymakers and industry leaders look for ways to improve efficiency and reduce costs in pharmaceutical production. Continuous manufacturing allows raw materials to be processed nonstop through a single system, which can lead to savings and improved quality control compared to the decades-old batch process.
Peter Navarro, President Donald Trump’s senior counselor for trade and manufacturing, said last summer that the administration's efforts would not only encourage domestic drug production but also promote more modern methods. “We’re going to have the ability to fast track things like advanced continuous manufacturing rather than batch manufacturing,” Navarro told CNBC. “If you could do it with advanced manufacturing, continuous manufacturing, you save a ton of money.”
However, John Murphy, CEO of the Association for Accessible Medicines (AAM), questioned what generics companies would gain from investing in new technologies. “We need to define the why. It’s not clear to us right now exactly whether or not we get anything better” for adopting continuous manufacturing, Murphy said. He added that while there are economies of scale with advanced methods, “there’s an enormous startup cost associated with that.”
Kevin Webb, president and COO of APIIC, identified these upfront costs as a major barrier for manufacturers. Companies “just can’t afford it,” Webb told BioSpace. To address this issue, APIIC places equipment at manufacturers’ facilities without selling it directly to them—a strategy intended to reduce financial risk and encourage adoption of new technology. “This is where the federal government comes in. Using their funding, we are starting to place equipment with manufacturers across the country,” Webb said.
APIIC received $14 million from the Administration for Strategic Preparedness and Response in 2024 and has used these funds for research and development in Missouri. The organization has also partnered with Apertus Pharmaceuticals on producing lomustine—a chemotherapy drug—using continuous processes supported by state investment and a $9.5 million grant from Missouri Technology Corporation’s Advanced Manufacturing Resiliency Grant Program in 2023.
An APIIC spokesperson said analytical work is ongoing at Apertus’s facility and that state support will help expand capacity for other high-potency drugs as well. Early results may demonstrate whether removing financial barriers can make U.S.-based ingredient production safer and more efficient.
