Overview
- Sens. Chris Coons and Ted Budd introduced the Biomanufacturing Excellence Act on Nov. 18, with a House companion, H.R. 6089, led by Reps. Chrissy Houlahan, Jim Baird, David Rouzer, and Deborah Ross.
- The legislation directs NIST to establish a National Biopharmaceutical Manufacturing Center of Excellence through an open competition as a public‑private partnership.
- The center would host facilities that mirror industrial conditions and meet FDA CGMP requirements to test scalable processes and demonstrate methods aligned with QbD and CMC guidance.
- Activities would focus on scaling products critical to national security, public health, and economic security while expanding hands‑on workforce training via partnerships with academia, industry, and community groups.
- Backers frame the bill as a response to NSCEB warnings about eroding U.S. competitiveness, noting China’s rising share of global pharmaceutical output, with the measure now awaiting committee consideration.