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On November 18, 2025, Senators Chris Coons (D-DE) and Ted Budd (R-NC) introduced the Biomanufacturing Excellence Act, which would promote U.S. leadership in biotechnology and strengthen domestic biopharmaceutical manufacturing. Coons' November 18, 2025, press release states that "[b]iotechnology will shape how the United States defends itself, secures its food supply, and cures life-threatening diseases." According to the National Security Commission on Emerging Biotechnology's (NSCEB) final report, without rapid and significant investment, the United States will fall behind global competitors such as China. The legislation reinvests in domestic biopharmaceutical manufacturing, reducing dependence on foreign supply chains, expanding access to cutting-edge medicines, and supporting high-quality American jobs. The bill would establish a public-private center dedicated to advancing biopharmaceutical manufacturing, a key recommendation from NSCEB's final report. 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 the U.S. 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; and
- Train tomorrow's biopharmaceutical manufacturing workforce by partnering with educational, industry, and community leaders to bolster biotechnology talent.
Companion legislation (H.R. 6089) is being led in the House by Representatives Chrissy Houlahan (D-PA), Jim Baird (R-IN), David Rouzer (R-NC), and Deborah Ross (D-NC). More information on NSCEB's final report is available in our April 25, 2025, blog item.
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