Congress introduces bill to create national biomanufacturing center of excellence

To help counter China’s efforts to become the world leader in biotechnology, a bipartisan group of lawmakers in the U.S. Senate and House of Representatives have introduced legislation to establish a National Biopharmaceutical Manufacturing Center of Excellence.

The Biomanufacturing Excellence Act of 2025 seeks to establish a dedicated national center aimed at strengthening America’s capacity for biopharma manufacturing. 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.

“By supporting public-private collaboration and growing our domestic manufacturing base, this legislation ensures the United States can remain competitive, reduce reliance on foreign supply chains, and equip the next generation of biotechnology leaders to drive our nation forward,” Rep. David Rouzer (R-N.C.), a sponsor of the bill, said in a statement.

The bill’s concept of a public-private biopharma manufacturing center of excellence (COE) was inspired by recommendations in an April 2025 report from the National Security Commission on Emerging Biotechnology (NSCEB), which recommended that Congress direct the U.S. Department of Commerce to create a COE focused on developing and scaling new ways to make medicines.

“Manufacturing innovations that are under development, such as greater automation and continuous manufacturing (a process by which inputs are continuously fed into a system, as opposed to made in batches), could change the paradigm for biomanufacturing,” according to NSCEB’s report, leading to “smaller, less expensive facilities that use modular equipment and cleanrooms to manufacture products at lower cost while using less energy.”

NSCEB, which supports the Biomanufacturing Excellence Act, contends that biomanufacturing requires flexible and affordable infrastructure to ensure innovative products can quickly move from the lab to commercial-scale U.S. production.

“Once a manufacturing method has gained regulatory approval, a biopharmaceutical company’s incentive to iterate on that method decreases, since a change could require additional regulatory scrutiny,” according to NSCEB. “As a result, companies may not pursue manufacturing innovations, even when they are potentially more effective or efficient.”

However, NSCEB argues that a public-private COE will help to advance these manufacturing processes to full-scale U.S. production and engage regulators to ensure alignment with regulatory requirements. 

Dominick DiSabatino, a partner on the life sciences team at law firm Sheppard Mullin, wrote in a blog post that through the COE, the Biomanufacturing Excellence Act targets the demonstration of flexible and multi-platform manufacturing technologies, improvements in upstream and downstream processes, as well as the standardization of quality and controls such as Chemistry, Manufacturing, and Controls (CMC).

According to DiSabatino, the bill’s focus on the standardization of CMC and support for cGMP “directly touches the regulatory controls that sponsors must meet” and “dovetails with ongoing FDA initiatives around modernizing manufacturing” such as Quality by Design (QbD), continuous manufacturing, modular facilities, and flexible platforms.

DiSabatino notes that the goal of the COE is to promote U.S. biopharma innovation by providing a “laboratory-to-pilot-to-manufacturing bridge” which may reduce risk and cost for sponsors and accelerate the commercialization of biologics, cell and gene therapies, and other novel therapeutic modalities.

“While still at the introduction stage, the bill’s enactment could shift some early stage manufacturing-scale regulatory strategy development, change sponsor engagement with regulators on novel processes, and modify manufacturing innovation integration into regulatory submissions,” according to DiSabatino. “Organizations that might be impacted by this should consider whether manufacturing strategies, modular capacity planning, and process-development investments align with the COE’s likely focus areas.”