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# Bill to Strengthen Biopharmaceutical Manufacturing
- URL: https://www.fdaweb.com/bill-to-strengthen-biopharmaceutical-manufacturing/
- Published: 2025-11-19T12:00:00.000Z
- Updated: 2026-09-14T15:27:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160248

Sens. **Chris Coons** (D-DE) and **Ted Budd** (R-NC) have introduced the Biomanufacturing Excellence Act that they say would promote U.S. leadership in biotechnology and strengthen domestic biopharmaceutical manufacturing. A [statement](https://www.coons.senate.gov/news/press-releases/senators-coons-budd-introduce-bicameral-bipartisan-legislation-to-strengthen-us-biopharmaceutical-manufacturing?ref=fdaweb.com) (includes links to the bill text and a one-page summary) from Coons says the legislation would establish the National Biopharmaceutical Manufacturing Center of Excellence, a public-private center dedicated to advancing biopharmaceutical manufacturing, which was a recommendation from a National Security Commission on Emerging Biotechnology report.

Coons says the center 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 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 education, industry, and community leaders to bolster biotechnology talent.

Companion bipartisan, bicameral legislation has been introduced in the House.