Bipartisan Senate and House Members Introduce Legislation to Boost American Biotech Manufacturing Infrastructure and Innovation
The National Biopharmaceutical Manufacturing Center of Excellence is a public-private partnership that will allow innovators to scale their products here in the U.S. with smarter, faster, more efficient manufacturing practices.
18, November 2025
FOR IMMEDIATE RELEASE
Washington, DC – Today, a bipartisan, bicameral group of Senators and Representatives introduced legislation to establish a National Biopharmaceutical Manufacturing Center of Excellence (COE), inspired by recommendations from the National Security Commission on Emerging Biotechnology’s April 2025 Action Plan for Congress.
The bill would create a public-private partnership focused on advancing innovation in biopharmaceutical manufacturing methods, especially for products important to U.S. national security, health security, and economic security. It would also improve regulatory understanding of innovative manufacturing methods and provide workforce training opportunities in this fast-growing field.
In the Senate, the legislation was introduced by Senator Coons (D-DE) and Senator Budd (R-NC), and in the House, the bill was introduced by Rep. Houlahan (D-PA, 06), Rep. Baird (R-IN, 04), Rep. Rouzer (R-NC, 07), and Rep. Ross (D-NC, 02).
LEGISLATIVE OVERVIEW:
Establishment: Directs the National Institute for Standards and Technology (NIST) to establish the COE as a public-private partnership through an open competition.
Activities: Creates a center for innovation focused on advancing biopharmaceutical manufacturing; conducts research and development on and houses multi-platform and multi-product manufacturing systems; and prioritizes products and processes that are important to U.S. national security, health security, and economic security.
Cutting-Edge Manufacturing: Allows innovators to test innovative manufacturing methods and engage with regulators to demonstrate the cutting-edge of biopharmaceutical manufacturing in an environment that supports Current Good Manufacturing Practice (CGMP), Quality by Design (QbD), Chemistry, Manufacturing, and Controls (CMC), and other relevant guidance.
Workforce and Education: Provides hands-on training and educational opportunities to academic and community partners to bolster biopharmaceutical talent.
“I am grateful to our congressional partners for their strong commitment to the future of U.S. biotechnology leadership and their introduction of this important legislation,” said NSCEB Vice Chair Michelle Rozo. “In our report, we found that advancing innovation in the biopharmaceutical sector is essential to catalyzing full-scale production for new medicines in the United States, and this center would bring together industry, academia, and government to do just that. Through our Biotech Across America roadshow, I’ve had the opportunity to personally visit biotech hubs around the country to see the impact this type of cutting-edge biomanufacturing innovation can have on U.S. national, health, and economic security.”
“Delaware and innovation have always gone hand in hand,” said Senator Coons (D-DE). “The extraordinary biomedical research that happens in the First State has grown our economy, turned start-ups into industry leaders, and saved lives around the world. China is surging ahead in biotechnology, putting our national security, economy, and health at risk. This bipartisan bill will ensure the United States continues to lead the world in biotech manufacturing, protecting Americans’ security and our health.”
“Southeastern Pennsylvania has a storied history as a global leader in the life sciences. Yet too many of our breakthroughs struggle to reach patients and markets because we lack the biomanufacturing capacity to scale and commercialize them. That gap threatens jobs, our regional competitiveness, and our access to medicines, applications, solutions and treatments Americans and our nation need. Our bipartisan Biomanufacturing Excellence Act tackles this head-on by creating a national Center of Excellence to drive innovation in biopharmaceutical manufacturing. The bill would cut costs, speed production, and grow our biotech workforce here in our Commonwealth. As competitors like the Chinese Communist Party race to dominate this space, we cannot afford to fall behind,” said Representative Chrissy Houlahan (D-PA).
“Not only is biomanufacturing a key pillar of America’s and North Carolina’s innovation economy, it has the potential to transform major aspects of everyday life. We must foster this critical technology and continue to lead the world in enabling life-saving medical breakthroughs, fortifying our critical supply chains, and creating good-paying, high-skilled jobs. I am proud to partner with Senator Coons to help build on the public-private partnerships that have unlocked significant economic potential and unleashed next-generation technology,” said Senator Ted Budd (R-NC).
“A strong domestic biopharmaceutical manufacturing industry is vital to developing innovative treatments to cure and manage diseases, improving public health, and securing our supply chains,” said Congressman Baird (R-IN). “Communist China has been closing the innovation gap with the U.S., creating an urgent need for strengthening our domestic biomanufacturing capabilities. I’m proud to join Congresswoman Houlahan on this bipartisan legislation to reduce our reliance on an adversary for life-saving treatments, encourage innovation in biopharmaceutical manufacturing, and ensure our country continues to lead the world in finding groundbreaking cures.”
“North Carolina is a national leader in biotechnology and innovation,” said Congresswoman Deborah Ross (D-NC). “Our state is home to world-class researchers and companies, who are changing the future of medicine and stand ready to spearhead our country’s leadership in biomanufacturing. Investing in innovation here at home will strengthen our supply chains, make our communities more secure, bolster our economy, and help save lives. I’m proud to join a bipartisan group of colleagues in introducing this important legislation that will invest in the future of medicine.”
“Biotechnology is rapidly reshaping national defense, health security, and our economy’s resilience. As home to one of the strongest biotech and biomanufacturing ecosystems in the country, North Carolina has demonstrated how innovation can strengthen America’s ability to develop and produce life-saving medicines,” said Congressman Rouzer (R-NC). “The Biomanufacturing Excellence Act reaffirms our commitment to expanding that capacity here at home. 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.”
About NSCEB: The National Security Commission on Emerging Biotechnology is a time-limited, high-impact legislative branch advisory entity whose purpose is to advance and secure biotechnology, biomanufacturing, and associated technologies for U.S. national security and to prepare the United States for the bioindustrial revolution. The Commission published a comprehensive report in April 2025, including recommendations for action by Congress and the federal government. The bipartisan Commission is composed of Congressionally-appointed Commissioners with members from both the Senate and the House of Representatives as well as experts from industry, academia, and government. For more information about the Commission and to view the report, visit: biotech.senate.gov.
Contacts:
NSCEB: press@biotech.senate.gov
