US biomanufacturing needs cohesive strategy to compete with China, says commission

The National Security Commission on Emerging Biotechnology (NSCEB) took its “Biotech Across America Roadshow” to Pittsburgh on Thursday, as part of its call to action for U.S. investment in biomanufacturing.

With China aggressively pursuing a strategy to become the world’s biotech leader, the U.S. government must invest a minimum of $15 billion over the next five years, according to the commission. NSCEB’s April 2025 report to Congress found that the U.S. lacks biomanufacturing capacity to ensure it maintains global dominance over China in biotech.

Thursday’s visit to Pittsburgh was the latest stop on NSCEB’s nationwide roadshow to highlight the key findings and recommendations of the commission’s report.

“One of the macro-observations of the commission was that while we are extraordinarily good as a country at early-stage innovation, we have historically struggled to commercialize and scale up those innovations,” said NSCEB Executive Director Caitlin Frazer.

The report concluded that U.S. biomanufacturing faces several barriers including regulatory hurdles, inefficient biological yields, lack of standardization, and limited domestic scale-up capacity as “researchers are generating new products faster than manufacturing capacity is increasing.”

NSCEB has called for the mobilization of the private sector to get U.S. products to scale, making the case that strengthening biomanufacturing in this country is critical to maintaining America’s lead in biotechnology.

Scaling up with advanced technologies

Frazer acknowledged the “capital intensity” of creating an at-scale manufacturing infrastructure in the U.S. biotech sector. “These are heavy CAPEX investments,” she said. 

NSCEB’s report noted that building new facilities is expensive and time-consuming, with precommercial sites costing $100 million to $200 million — while facilities for commercial scale can take two to five years to build and prepare with costs up to $2 billion.

Frazer made the case that the U.S. must address the “cost inefficiencies of the incumbent means” of biomanufacturing by adopting “advanced manufacturing techniques and the science of scale-up.” Those technological areas are where the country stands to accelerate opportunities for manufacturing efficiency, she added. 

Innovations such automation and continuous manufacturing “could change the paradigm for biomanufacturing” leading to “smaller, less expensive facilities that use modular equipment and cleanrooms to manufacture products at lower cost while using less energy,” NSCEB wrote in its report to Congress.

“Despite early signs of promise, both the bioindustrial and biopharmaceutical sectors have been slow to develop and adopt these technologies, primarily because of concerns that they might pose regulatory risk and not recoup their capital investments,” the report said.

Need for congressional, other funding

To boost technology adoption, NSCEB called on Congress to invest in the “science of biomanufacturing scale-up” and undertake biomanufacturing grand challenges, creating “data-sharing platforms and artificial intelligence/machine learning (AI/ML) tools to accelerate biomanufacturing design” and supporting “domestic precommercial facilities that integrate expanding state-of the-art infrastructure to help innovators mature their technologies.”

Among NSCEB’s other recommendations, the report said Congress must authorize and fund the Department of Energy and Department of Commerce to develop a network of manufacturing facilities across the country for precommercial bioindustrial product scale-up.

In November 2025, a bipartisan group of lawmakers in the Senate and House of Representatives introduced legislation to establish a National Biopharmaceutical Manufacturing Center of Excellence aimed at strengthening U.S. biomanufacturing capacity.

The bill’s concept of a manufacturing center of excellence (COE) was inspired by NSCEB’s recommendation that Congress direct the Department of Commerce to create a COE focused on developing and scaling new ways to make medicines.

Among other functions, the public-private center would host a facility that replicates industrial operational conditions and complies with the FDA’s current Good Manufacturing Practice (cGMP) regulations, where innovators could develop and test new processes.

“We were over in Belgium, in Ghent, and they’ve got a facility where you take what you’ve developed in the lab, you test it out, and you see whether you can really build to scale — we don’t have much of that here,” said Dov Zakheim, an NSCEB commissioner and senior advisor at the Center for Strategic and International Studies.

The only way the U.S. will be able to implement such a capability nationwide is a combination of federal, state, and private industry funding, according to Zakheim, who noted that the Ghent facility was funded by the European Union as well as the Belgium and local Flemish governments.

“That’s really the bottom line here,” Zakheim concluded. “If you want to be leading the world, not just in coming up with ideas but actually producing something, you’ve got to make this a national thing.”