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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3188 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 3188
To establish a Biopharmaceutical Center of Excellence, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
November 18, 2025
Mr. Coons (for himself and Mr. Budd) introduced the following bill;
which was read twice and referred to the Committee on Commerce,
Science, and Transportation
_______________________________________________________________________
A BILL
To establish a Biopharmaceutical Center of Excellence, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Biomanufacturing Excellence Act of
2025''.
SEC. 2. FINDINGS; SENSE OF CONGRESS.
(a) Findings.--Congress finds the following:
(1) Biotechnology is the designing and engineering of
biological systems. Biotechnology allows scientists to grow
everything from medicines to crops to materials, enabling
``biology by design''.
(2) Biotechnology holds the potential for the United States
to transform its military capabilities, strengthen food
security and agricultural resilience, and cure life-threatening
diseases, but it holds that same potential for other countries.
The countries that master biotechnology first will gain the
ability to shape how those technologies are used for decades to
come.
(3) Biotechnology unlocks the capabilities of producing
medicines via biological systems, known as biopharmaceutical
manufacturing. Biopharmaceutical manufacturing will enable
better and less invasive treatments that extend and improve
lives.
(4) By investing in biomanufacturing, the United States
Government would reduce dependency on foreign supply chains.
(5) For United States manufacturers, the biggest roadblock
to commercialization is proving that their products and
processes can scale and produce a return on investment.
Biomanufacturing requires flexible and affordable
infrastructure for development, to ensure that innovative
products can rapidly move from the lab to commercial-scale
production.
(b) Sense of Congress.--It is the sense of Congress that--
(1) to realize the potential of biotechnology, the United
States Government should establish a biopharmaceutical
manufacturing center of excellence;
(2) the center should facilitate and accelerate
manufacturing innovation, support good manufacturing practices,
and provide for collaboration among public, private, and
nonprofit institutions; and
(3) the center should also facilitate training for workers
to operate biotechnology tools and equipment and to bolster
talent throughout the biotechnology sector.
SEC. 3. ESTABLISHMENT OF NATIONAL BIOPHARMACEUTICAL CENTER OF
EXCELLENCE.
The National Institute of Standards and Technology Act (15 U.S.C.
271 et seq.) is amended--
(1) by redesignating section 36 as section 37; and
(2) by inserting after section 35 the following:
``SEC. 36. NATIONAL BIOPHARMACEUTICAL CENTER OF EXCELLENCE.
``(a) Establishment of Center of Excellence.--
``(1) In general.--The Director shall award a grant to or
enter into an other transaction agreement with, on a
competitive basis, an eligible entity to establish and operate
a center of excellence to be known as the National
Biopharmaceutical Manufacturing Center of Excellence (in this
section referred to as the `Center of Excellence').
``(2) Objectives.--The objectives of the Center of
Excellence include--
``(A) advancing the science of biopharmaceutical
manufacturing, especially with respect to products of
particular importance to the national security, health
security, or economic security of the United States,
including by--
``(i) developing and demonstrating flexible
biopharmaceutical manufacturing technologies
and systems;
``(ii) improving upstream and downstream
processes for multiple biopharmaceutical
manufacturing platforms or product modalities;
``(iii) improving biopharmaceutical
manufacturing equipment and capabilities; and
``(iv) reducing supply bottlenecks and
strengthening supply chain self-sufficiency
through demonstration of innovative
technologies;
``(B) supporting good manufacturing practices,
quality by design, and standardization of chemistry,
manufacturing, and controls to ensure effective and
efficient manufacturing and to improve the regulation
of innovative methods of manufacturing;
``(C) advancing workforce training and development
by working with educational and community partners to
bolster biotechnology talent;
``(D) developing the science of and deploying the
infrastructure for innovative biopharmaceutical
manufacturing by engaging with--
``(i) institutions of higher education;
``(ii) small, medium, and large
pharmaceutical manufacturers;
``(iii) Federal, State, and local
government agencies and institutes;
``(iv) non-profit organizations;
``(v) professional organizations; and
``(vi) any other entity the Director
considers relevant;
``(E) sharing with the head of any Executive agency
that oversees the planning, management, or coordination
of Federal activities relating to biotechnology
research generated by the Center of Excellence,
including data regarding best practices for
biopharmeceutical manufacturing; and
``(F) any other objective the Director considers
relevant.
``(3) Funding.--The Director shall award the Center of
Excellence funding for any of the following:
``(A) To facilitate the construction of facilities
necessary to accomplish the objectives described in
paragraph (2).
``(B) To conduct collaborative research on new
technology for scaling biopharmaceutical manufacturing
in the United States for commercial production.
``(C) To facilitate workforce training programs for
biopharmaceutical manufacturing.
``(D) To fund relevant research and programs for
the development of biopharmaceutical manufacturing.
``(b) Application; Award.--
``(1) In general.--Not later than 180 days after the date
of the enactment of this section, the Director shall solicit
applications from eligible entities specified in paragraph (2)
and award to or enter into with one such entity a grant or
other transaction agreement to establish the Center of
Excellence.
``(2) Eligibility.--An entity is eligible to submit an
application pursuant to paragraph (1) if--
``(A) the entity is--
``(i) a public-private partnership;
``(ii) an institution of higher education;
or
``(iii) a consortia of entities specified
in clauses (i) or (ii); and
``(B) the entity is not a Federal entity.
``(3) Content of application.--An application submitted by
an entity pursuant to paragraph (1) shall include--
``(A) examples from the entity of previous
research, development, implementation, and
demonstration of innovative practices of
biopharmaceutical manufacturing;
``(B) a description of the manner by which the
entity plans to advance the science of
biopharmaceutical manufacturing, especially with
respect to products of particular importance to the
national security, health security, or economic
security of the United States;
``(C) a description of the manner by which the
entity plans to incorporate good manufacturing
practices, quality by design, and standardization of
chemistry, manufacturing, and controls, and similar
guidance to ensure effective and efficient
manufacturing and to make innovative methods of
manufacturing more understandable to Executive agencies
that are tasked with regulating such methods;
``(D) examples of trainings facilitated by the
entity that prepare workers for the biotechnology
sector;
``(E) a description of any existing partnerships
with educational or community partners that help
facilitate workforce training for the biotechnology
sector;
``(F) a description of any experience participating
in or leading biopharmaceutical manufacturing
partnerships, including those with institutions of
higher education, pharmaceutical manufacturers, non-
profit organizations, and governmental agencies--
``(i) to organize and conduct research and
development aimed at--
``(I) creating and standardizing
new and more effective technology;
``(II) developing best practices
and sharing knowledge about such
technology;
``(III) creating intellectual
property; and
``(IV) maintaining technological
leadership in the United States;
``(ii) to support the deployment of
innovative practices and infrastructure of
biopharmaceutical manufacturing in the United
States; and
``(iii) to support developing a skilled
workforce ready to use innovations in the
biopharmaceutical manufacturing sector; and
``(G) a description of how the entity intends to
utilize any funds authorized under this section to
build or expand facilities and infrastructure to
achieve any of the objectives described in subsection
(a)(2).
``(4) Selection criteria.--In selecting an applicant for a
grant or other transaction agreement under paragraph (1), the
Director shall consider the following:
``(A) The potential of the applicant to establish a
Center of Excellence that would achieve the objectives
set forth in subsection (a)(2).
``(B) The past performance of the applicant in
biopharmaceutical manufacturing workforce development
and the potential of the applicant to support workforce
development activities in various regions throughout
the United States.
``(C) The extent to which the applicant proposes to
leverage the activities of other biopharmaceutical
manufacturing innovation, development, and scaling
initiatives.
``(D) Whether the proposed location for the Center
of Excellence is proximate to other biomanufacturing
infrastructure, training facilities, or industrial
clusters.
``(E) The time the applicant estimates is needed
for the Center of Excellence to be fully operational
and to start delivering impact.
``(F) The amount of co-investment committed by
Federal, State, private, and other sources to establish
the Center of Excellence.
``(G) Any additional criteria that the Director
considers relevant.
``(c) Annual Reports.--
``(1) Initial report.--Not later than one year after the
date on which the Director awards to or enters into with an
eligible entity a grant or other transaction agreement to
establish the Center of Excellence under subsection (b)(1), the
Director shall submit to Congress a report describing the
progress on establishing the Center of Excellence, including--
``(A) the construction of facilities;
``(B) any activities, partnerships, and
collaborations by the Center of Excellence; and
``(C) any other information regarding the formation
of the Center of Excellence that the Director considers
relevant.
``(2) Progress report.--Not later than one year after the
date on which operations at the Center of Excellence officially
begin, the Director shall submit to Congress a report
describing--
``(A) the activities, partnerships, collaborations,
and findings of the Center of Excellence; and
``(B) any other information regarding the Center of
Excellence that the Director considers relevant.
``(3) Final report.--Not later than 5 years after the date
on which operations at the Center of Excellence officially
begin, the Director shall submit to Congress a report
describing--
``(A) the activities, partnerships, collaborations,
and findings of the Center of Excellence; and
``(B) any other information regarding the Center of
Excellence that the Director considers relevant.
``(4) Publication.--The Director shall make the reports
required by paragraphs (1), (2), and (3) available to the
public in an easily accessible electronic format on a website
of the Federal Government that includes information on
biotechnology.
``(d) Intellectual Property.--The Director shall ensure that, prior
to commencing operations, the Center of Excellence, in consultation
with similar existing institutions, such as Manufacturing USA
institutes (as defined in section 34(d)), establishes intellectual
property guidelines for research conducted within or in collaboration
with the Center of Excellence.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to the Director to carry out this section $120,000,000 for
fiscal year 2026.
``(f) Definitions.--In this section:
``(1) Biomanufacturing.--The term `biomanufacturing' means
the application of biotechnology to manufacturing.
``(2) Biopharmaceutical.--The term `biopharmaceutical'
means a pharmaceutical drug product manufactured using,
extracted from, or synthesized from living cells or biological
organisms.
``(3) Biotechnology.--The term `biotechnology' means the
application of science or engineering, directly or indirectly,
to--
``(A) a living organism;
``(B) a part or product of a living organism; or
``(C) a modified form of subparagraph (A) or (B).
``(4) Executive agency.--The term `Executive agency'--
``(A) has the meaning given that term in section
105 of title 5, United States Code; and
``(B) includes the Executive Office of the
President and the Office of the Vice President.
``(5) Institution of higher education.--The term
`institution of higher education' has the meaning given that
term in section 101 of the Higher Education Act of 1965 (20
U.S.C. 1001).''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Commerce, Science, and Transportation.
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