Senators Coons, Budd introduce bicameral, bipartisan legislation to strengthen U.S. biopharmaceutical manufacturing

WASHINGTON - Today, U.S. Senators Chris Coons (D-Del.) and Ted Budd (R-N.C.) introduced the Biomanufacturing Excellence Act, which would promote U.S. leadership in biotechnology and strengthen domestic biopharmaceutical manufacturing.

Biotechnology will shape how the United States defends itself, secures its food supply, and cures life-threatening diseases. National Security Commission on Emerging Biotechnology (NSCEB) 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 5% in 2002 to nearly 25% in 2019. This legislation reinvests in domestic biopharmaceutical manufacturing, reducing dependence on unreliable foreign supply chains, expanding access to cutting-edge medicines, and supporting high-quality American jobs. Companion legislation is being led in the U.S. House by Representatives Chrissy Houlahan (D-Pa.), Jim Baird (R-Ind.), David Rouzer (R-N.C.), and Deborah Ross (D-N.C.).

The Biomanufacturing Excellence Act would establish a public-private center dedicated to advancing biopharmaceutical manufacturing - a key recommendation from the National Security Commission on Emerging Biotechnology (NSCEB) report.

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

"Delaware and innovation have always gone hand in hand," said Senator Coons. "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."

"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 Budd.

"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 Houlahan.

"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. "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."

"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. "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."

"North Carolina is a national leader in biotechnology and innovation," said Congresswoman Ross. "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."

The bill is endorsed by the National Security Commission on Emerging Biotechnology (NSCEB), the Delaware BioScience Association, the Biotechnology Innovation Organization, the Information Technology and Innovation Foundation (ITIF), NCLifeSci and NCBiotech, Life Sciences Pennsylvania, and the American Alliance for Biomanufacturing.

"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."

"The United States must remain the global leader in biopharmaceuticals and advanced manufacturing to safeguard our nation's health, economic vitality and national security. The National Biopharmaceutical Manufacturing Center of Excellence will help drive this mission forward by aligning industry, academia and workforce partners to test new technologies under real manufacturing conditions and train skilled professionals for great careers - ultimately accelerating innovation, lowering costs and getting more life-changing therapies to patients faster," said Michael Fleming, President and CEO, Delaware BioScience Association.

"ITIF supports the bipartisan Biomanufacturing Excellence Act, which would create a National Biopharmaceutical Manufacturing Center of Excellence that would convene industry, academic, and government stakeholders to ensure that America leads in the biomanufacturing revolution of the future. With experts estimating that 60 percent of the world's physical inputs could be made using biological processes going forward, biomanufacturing won't just transform the future of medicines, but also everything from energy, to food, to industrial manufacturing. The Biomanufacturing Excellence Act will help equip the United States with the technology, workforce, and knowhow to achieve leadership in this critical emerging field," a statement from the Information Technology and Innovation Foundation (ITIF) reads.

"The creation of a National Biopharmaceutical Manufacturing Center of Excellence is pivotal to advancing US leadership in bioprocess innovation, supply chain resiliency, and workforce competitiveness. We greatly appreciate Congressional leadership in recognizing the importance of biomanufacturing to national and economic security. For over four decades, North Carolina has created an integrated ecosystem focused on a steadfast commitment to life sciences manufacturing, establishing the state as a global leader with over $17 Billion of investment and 7,500 jobs announced since 2021. This success is built on a community of partners that work to seamlessly integrate world-class institutions of innovation with over 150 life sciences manufacturing companies, forming a uniquely dense hub for accelerating the translation of cutting-edge biomanufacturing innovations to scaled commercial outputs," a joint statement from NCLifeSci and NCBiotech reads.

"We are living in an extraordinary era for biotechnology-one where innovation, data-driven insights, and public-private partnerships are transforming what's possible for patients. Maintaining U.S. leadership in this sector is critical for our economic and national security. The Biotechnology Innovation Organization applauds Senators Chris Coons and Ted Budd, and Representatives Chrissy Houlahan, David Rouzer, Deborah Ross, and Jim Baird for introducing legislation that will help grow and expand the biotechnology sector to more communities across the country and better position the U.S. to develop and manufacture the next generation of medical advances," said the Biotechnology Innovation Organization.

"Pennsylvania's collaborative life sciences ecosystem has made our commonwealth a national leader in biopharmaceutical manufacturing for decades. We recognize the importance of the bipartisan and bicameral Biopharmaceutical Manufacturing Center of Excellence Act. This legislation will help incentivize and protect national security as well as ensure a steadfast supply chain in delivering treatments and therapeutics in Pennsylvania, across the Country, and around the world," said Christopher P. Molineaux, President and CEO of Life Sciences PA.

"The Biomanufacturing Excellence Act is a decisive investment in America's health, security, and economic strength. The American Alliance for Biomanufacturing is proud to support this effort to bring cutting-edge biomanufacturing back home," said Brooke Coleman, Executive Director, American Alliance for Biomanufacturing.

The full text of the bill is available here.

A one-pager on the bill is available here.