A bipartisan 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 (NSCEB) April 2025 Action Plan for Congress.
In the Senate, the legislation was introduced by Sen. Coons (D-DE) and Sen. 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).
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.
Biotechnology will shape how the U.S. defends itself, secures its food supply, and cures life-threatening diseases. The NSCEB has warned that without rapid and significant investment, the U.S. will fall behind its global competitors, specifically China.
China’s share of global pharmaceutical output has surged from about five percent in 2002 to nearly 25% in 2019. This legislation reinvests in domestic biopharmaceutical manufacturing, reducing dependence on unreliable foreign supply chains, expanding access to innovative medicines, and supporting high-quality American jobs.
Specifically, the National Biopharmaceutical Manufacturing Center of Excellence would:
- Unite industry professionals with academic researchers to conduct collaborative research on new technology for scaling biopharmaceutical manufacturing
- Host a facility that replicates industrial manufacturing conditions and complies with FDA Current Good Manufacturing Practice (CGMP) regulations, where innovators would develop and test new manufacturing processes
- Identify challenges and opportunities for scaling biopharmaceutical manufacturing, especially for products important to U.S. national security, public health, and economic security
- Train tomorrow’s biopharmaceutical manufacturing workforce by partnering with educational, industry, and community leaders to bolster biotechnology talent
Details on the legislation
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.
Congressional reaction
“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.”
“China is surging ahead in biotechnology, putting our national security, economy, and health at risk,” noted Sen. Coons. “This bipartisan bill will ensure the United States continues to lead the world in biotech manufacturing, protecting Americans’ security and our health.”
“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 Sen. Budd.
“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,” added Rep. Baird. “I’m proud to join Congresswoman Houlahan on this bipartisan legislation to reduce our reliance on an adversary [China] for life-saving treatments, encourage innovation in biopharmaceutical manufacturing, and ensure our country continues to lead the world in finding groundbreaking cures.”
“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,” explained Rep. Houlahan.
The full text of the bill is available here.
A one-pager on the bill is available here.
The post Senate and House Introduce Bill to Boost U.S. Biotech Manufacturing Infrastructure, Innovation appeared first on GEN – Genetic Engineering and Biotechnology News.
