Industry groups have identified upfront costs as a barrier to streamlining U.S. drugmaking. The nonprofit API Innovation Center has a proposed answer for how to tilt finances in favor of investments in continuous manufacturing.
As the White House began ratcheting up pressure on drugmakers to reshore manufacturing last summer, President Donald Trump’s senior counselor for trade and manufacturing, Peter Navarro, outlined a plan to go beyond changing where medicines are made. In Navarro’s vision, as he described to CNBC, Trump’s actions would also improve on how drugs are made, replacing decades-old processes with more modern, advanced technologies.
Most drugs are made in batches in a process that has remained broadly the same for decades. After Trump told U.S. authorities to expand the Strategic API Reserve stockpile of drug ingredients in August 2025, Navarro pitched the White House’s actions as a way to shift away from that established model.
“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.”
Batch production is a stop-start process comprising discrete steps that happen in a defined order. By contrast, in continuous manufacturing, raw materials are fed nonstop into a single system. As the raw materials move along the line, they undergo chemical reactions or mechanical processing and emerge as the final product.
Real-time analysis and quality control tools have enabled companies to continuously monitor drug production parameters, rather than waiting until a product is ready to confirm its quality. Installing such equipment at existing sites allows manufacturers of active pharmaceutical ingredients and finished products to adopt continuous processes without building dedicated facilities.
Navarro framed continuous manufacturing as a way to save money and reduce waste, thus lowering a barrier to making drugs in the U.S. and encouraging onshoring. While companies including Eli Lilly, GSK, Johnson & Johnson and Vertex have adopted continuous processes for some drug substances and products, the upfront costs are a barrier to adoption for manufacturers of lower-margin, off-patent materials. One nonprofit has devised a way to cover these costs.
Clearing the Upfront Barrier
Shortly after Navarro made his comments in August, John Murphy, CEO of the Association for Accessible Medicines (AAM), told BioSpace that the plan to change how drugs are made in the U.S. was laudable. But Murphy asked what generics companies would get in return for investing in new ways of making medicines.
“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. “Obviously there are economies of scale if you’re doing more advanced continuous manufacturing, but there’s an enormous startup cost associated with that.”
At the nonprofit API Innovation Center (APIIC), President and COO Kevin Webb has a possible answer for how to tilt finances in favor of investments in continuous manufacturing.
Webb identified the same barrier to the adoption of new manufacturing technologies as Murphy. Companies “just can’t afford it,” he told BioSpace. In Webb’s view, use of continuous production methods that can improve productivity, purity and workplace safety is being held back by the inability to raise and justify the upfront costs.
To clear that initial financial barrier, APIIC uses a mix of state, federal, philanthropic and private-sector funding. The organization uses the money to devise ways to make existing drugs via continuous manufacturing and works with equipment companies to develop the reactors and pumps needed to run the new processes.
Webb has paired the process development strategy with a commitment to removing the upfront capital expenditure for the API manufacturers. APIIC places the equipment at the API manufacturer’s facility without selling it to them, Webb said, to derisk the 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.”
A Role for Public Funding
Founded in 2021, APIIC received $14 million in funding from the Administration for Strategic Preparedness and Response in 2024, which allowed the development of APIs using advanced processes in its R&D labs in Missouri. “The value proposition to them and to the country is that [the companies] hire more people, they expand their manufacturing lines,” Webb said.
APIIC is applying the model to lomustine, a chemotherapy used in the treatment of the most common and aggressive form of malignant brain cancer. Access to lomustine is a concern in multiple countries, with the U.S. facing price hikes and a Medicare coverage withdrawal in recent years and Canada extending expiration dates to mitigate the risk of a shortage.
Working with the Glioblastoma Foundation and supported by state investment, APIIC has created a continuous manufacturing process that Apertus Pharmaceuticals is adopting to make lomustine at a facility in Missouri. APIIC received a $9.5 million grant from the Missouri Technology Corporation’s Advanced Manufacturing Resiliency Grant Program in 2023.
An APIIC spokesperson said in late 2025 that analytical work is underway, and that Apertus will resume optimization efforts in the new year in its new cytotoxic suite. The spokesperson said APIIC and state support will enable Apertus to make lomustine and expand capacity for additional high-potency and oncolytic drugs. APIIC is also working with Sentio BioSciences on two other APIs.
The early test cases could provide evidence of the viability of implementing new approaches to API production and the impact on the cost of U.S.-based manufacturing. As such, the nonprofit has positioned itself to test the hypothesis that clearing upfront financial barriers to advanced manufacturing technologies will enable safer and more efficient production of ingredients in the U.S.
Correction (March 10): This story has been updated from its original version to correctly state that Kevin Webb is the president and COO of the API Innovation Center (APIIC), not the CEO. BioSpace regrets the error.
