Senators Budd, Coons Lead Bicameral, Bipartisan Push to Reinvest in Domestic Biopharmaceutical Manufacturing
Washington, D.C. — U.S. Senators Ted Budd (R-N.C.) and Chris Coons (D-Del.) introduced the bicameral, bipartisan Biomanufacturing Excellence Act this week, which would promote U.S. leadership in biotechnology and strengthen domestic biopharmaceutical manufacturing. The bill reinvests in domestic biopharmaceutical manufacturing by reducing dependence on unreliable foreign supply chains, expanding access to cutting-edge medicines, and supporting high-quality American jobs.
“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.
“Delaware and innovation have always gone hand in hand. 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,” said Senator Coons.
“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. 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,” said National Security Commission on Emerging Biotechnology, Vice Chair, Michelle Rozo.
“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.
“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 reads.
“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 American Alliance for Biomanufacturing, Executive Director, Brooke Coleman.
U.S. Representatives Chrissy Houlahan (D-Pa.-06), Jim Baird (R-Ind.-04), David Rouzer (R-N.C.-07), and Deborah Ross (D-N.C.-02) led the companion legislation in the House of Representatives.
The bill is endorsed by the National Security Commission on Emerging Biotechnology (NSCEB), NCLifeSci and NCBiotech, the Delaware BioScience Association, the Biotechnology Innovation Organization, the Information Technology and Innovation Foundation (ITIF), Life Sciences Pennsylvania, and the American Alliance for Biomanufacturing.
Read the full bill text HERE.
BACKGROUND
Biotechnology will shape how the U.S. defends itself, secures its food supply, and cures life-threatening diseases. NSCEB warned that without rapid and significant investment, the U.S. will fall behind its global competitors, specifically China.
The Biomanufacturing Excellence Act would additionally establish a public-private center dedicated to advancing biopharmaceutical manufacturing – a key recommendation from the 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 Food and Drug Administration’s (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
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