Biomanufacturing Excellence Act of 2025
- Bill Number
- S. 3188
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Science, Technology, Communications
- Status
- Introduced
- Latest Action
- 2025-11-18: Read twice and referred to the Committee on Commerce, Science, and Transportation.
- Last Updated
- 2026-05-20T11:03:28Z
AI-Generated Summary
Purpose of the Legislation
The Biomanufacturing Excellence Act of 2025 aims to create a National Biopharmaceutical Center of Excellence to promote innovation in biopharmaceutical manufacturing. This would help the United States lead in biotechnology, reduce reliance on foreign supply chains, improve health treatments, and build a skilled workforce, while addressing national security and economic needs.
Key Provisions
- Findings and Sense of Congress: Recognizes biotechnology's role in designing biological systems for medicines, crops, and materials. It highlights the need to invest in biomanufacturing (using biology to produce goods) to compete globally, ensure supply chain security, and support commercialization by providing flexible infrastructure.
- Establishment of the Center: Amends the National Institute of Standards and Technology (NIST) Act to create the National Biopharmaceutical Manufacturing Center of Excellence. The NIST Director awards a competitive grant or agreement to an eligible non-federal entity (such as a public-private partnership, university, or consortium) within 180 days of enactment.
- Objectives:
- Advance biopharmaceutical science, focusing on national security, health, and economic priorities (e.g., flexible manufacturing tech, process improvements, supply chain fixes).
- Promote good manufacturing practices (standards for safe, effective production), quality by design (building quality into products from the start), and standardization of chemistry, manufacturing, and controls (rules for drug production and testing).
- Support workforce training through partnerships with schools and communities.
- Foster collaborations with universities, manufacturers, governments, nonprofits, and others; share research with federal agencies.
- Funding and Activities: Authorizes $120 million for fiscal year 2026 to support facility construction, collaborative research on scaling production, workforce training, and related programs.
- Application and Selection Process:
- Eligible entities must submit detailed plans on past experience, manufacturing advancements, training programs, partnerships, and fund use.
- Selection considers potential impact, past performance in workforce development, leveraging existing initiatives, location near biotech hubs, timelines, co-investments, and other factors.
- Reporting Requirements: NIST must submit reports to Congress—one year after award (on setup), one year after operations begin (on progress), and five years after (final summary)—and make them publicly available online.
- Other Elements: Requires intellectual property (IP) guidelines for research, modeled on existing programs like Manufacturing USA. Defines key terms like "biomanufacturing" (biotech in manufacturing), "biopharmaceutical" (drugs from living cells or organisms), and "biotechnology" (science/engineering applied to living things).
Significant Changes to Existing Law
- Inserts a new Section 36 into the National Institute of Standards and Technology Act (15 U.S.C. 271 et seq.), which establishes the Center and its operations.
- Redesignates the existing Section 36 as Section 37 to accommodate the new addition.
- No other major overhauls; this builds on NIST's role in standards and innovation without altering broader federal biotech laws.
Potential Impacts
- Government Agencies: NIST gains oversight of the Center, including grant management and reporting. Other federal agencies (e.g., those handling biotech research or regulation) benefit from shared data on best practices, potentially streamlining approvals for new manufacturing methods.
- Citizens: Could lead to faster development of better, less invasive medicines, improved food security, and job opportunities in biotechnology through training programs, enhancing public health and economic resilience.
- International Relations: Strengthens U.S. leadership in biotech by reducing dependency on foreign suppliers, which may counter global competition (e.g., from other countries advancing in this field) and support national security without direct foreign policy changes.
Main Stakeholders Affected
- Federal Government: NIST (lead implementer), other executive agencies involved in biotech coordination, and Congress (receives reports).
- Industry and Nonprofits: Pharmaceutical manufacturers (small, medium, large), public-private partnerships, and nonprofits focused on biotech innovation and standards.
- Education and Workforce: Institutions of higher education, community training programs, and workers entering or advancing in the biotechnology sector.
- Broader Economy: State/local governments, professional organizations, and industrial clusters near biotech hubs, who may collaborate or benefit from infrastructure and jobs.
Notable Legal, Constitutional, or Political Implications
- Legal: Authorizes specific funding and creates a new federally supported entity, emphasizing competitive awards and IP protections to encourage private involvement while ensuring public accountability through reports. It aligns with existing regulatory frameworks (e.g., good manufacturing practices) to ease innovation without preempting agency rules.
- Constitutional: Falls under Congress's powers to regulate commerce, promote science/progress (Article I, Section 8), and appropriate funds, with no apparent conflicts to individual rights or federalism.
- Political: Bipartisan introduction (by Senators Coons and Budd) underscores broad support for domestic biotech investment amid concerns over supply chains and global competition. It promotes public-private collaboration, potentially influencing future funding debates on science and workforce development, but lacks controversial elements like mandates or penalties.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Sen. Coons, Christopher A. [D-DE]
Cosponsors (5)
Sen. Budd, Ted [R-NC], Sen. Padilla, Alex [D-CA], Sen. Young, Todd [R-IN], Sen. Tillis, Thomas [R-NC], Sen. Blunt Rochester, Lisa [D-DE]
Recent Actions
- 2025-11-18: Read twice and referred to the Committee on Commerce, Science, and Transportation.
- 2025-11-18: Introduced in Senate
Bill Versions
- Biomanufacturing Excellence Act of 2025 — issued 2025-11-18 — PDF (14 pages)