Biomanufacturing Excellence Act of 2025
- Sponsor
- Rep. Houlahan, Chrissy [D-PA-6]
- Committees
- Science, Space, and Technology Committee (primary)
- Last action
- Nov 18, 2025
Bottom line
The bill aims to strengthen U.S. biomanufacturing capabilities, reduce foreign supply chain dependency, and enhance workforce development through a new federally supported center.
What it actually does
This bill establishes a National Biopharmaceutical Manufacturing Center of Excellence within the National Institute of Standards and Technology (NIST). The center's objectives include advancing biopharmaceutical manufacturing science, supporting good manufacturing practices, developing infrastructure, and bolstering workforce training, particularly for products critical to national security, health security, and economic security. It authorizes $120 million for fiscal year 2026 to fund its establishment and initial operations.
Proponents argue
Supporters argue that establishing this Center of Excellence is crucial for the United States to maintain global leadership in biotechnology, enhance national security by reducing reliance on foreign supply chains for critical medicines, and stimulate economic growth through innovation and job creation in a vital sector. They emphasize its role in accelerating the commercialization of innovative biopharmaceutical products and ensuring a skilled workforce.
Opponents contend
Critics might contend that creating a new center could lead to bureaucratic inefficiencies or duplicate efforts already underway in existing public-private partnerships or research institutions. They might also question the effectiveness of a single center in addressing the broad challenges of biomanufacturing scale-up and workforce development across diverse regions, suggesting that existing mechanisms or more decentralized approaches might be more agile or cost-effective.
The bill is concise and can be read and understood by an informed reader within a short timeframe, making it accessible for evaluation.
Section 3, amending 15 U.S.C. 271 et seq. by inserting new Section 36(a)
Creation of the National Biopharmaceutical Manufacturing Center of Excellence
This provision directs the Director of the National Institute of Standards and Technology (NIST) to establish a new center, called the National Biopharmaceutical Manufacturing Center of Excellence. This center will be created through a competitive grant or agreement with an eligible non-federal entity, such as a public-private partnership or an institution of higher education. Its core mission is to advance the science and infrastructure of biopharmaceutical manufacturing, especially for products vital to national security, health, and economic stability.
Supporters argue
Supporters argue that a dedicated center is essential to consolidate efforts, accelerate innovation, and provide the necessary infrastructure and expertise to scale up biopharmaceutical manufacturing within the U.S., thereby reducing reliance on foreign supply chains and bolstering national preparedness.
Critics contend
Critics might suggest that existing research institutions and private sector investments are already addressing these needs, and a new federal center could create redundancy or divert resources from more agile, decentralized initiatives.
Tradeoffs
The tension lies between creating a centralized hub for innovation, which offers coordinated effort and significant resources, versus potentially stifling distributed innovation or duplicating existing private and academic research efforts.
Section 3, new Section 36(a)(2) and (a)(3)
Mandated Objectives and Permitted Funding Uses for the Center
This provision outlines the specific goals for the Center of Excellence, including advancing manufacturing science, developing flexible technologies, improving processes, supporting good manufacturing practices (GMP) and quality by design (QbD), fostering workforce training, and engaging diverse partners. It also specifies that the funding provided to the Center can be used for constructing facilities, conducting collaborative research on scaling biopharmaceutical manufacturing, facilitating workforce training programs, and supporting relevant research and development.
Section 3, new Section 36(e)
Funding Authorization for the Center
This provision authorizes the appropriation of $120,000,000 for fiscal year 2026 to the Director of NIST specifically for carrying out the activities related to establishing and operating the National Biopharmaceutical Manufacturing Center of Excellence. This amount provides the initial financial backing for the center's creation, including potential facility construction, research, and workforce training as outlined in its objectives.
Requires the Center of Excellence to establish intellectual property (IP) guidelines for research conducted within or in collaboration with it, in consultation with similar existing institutions like Manufacturing USA institutes, prior to commencing operations.
Section 3, new Section 36(d)
Why it matters:This is standard legislative practice for administrative details that are crucial for long-term operation but not central to the immediate establishment of the center.
Case for: Supporters argue that clear IP guidelines are essential for fostering collaboration between public and private entities, ensuring fair distribution of benefits, and incentivizing innovation by protecting the rights of all parties involved in research.
Case against: Critics might argue that overly restrictive or complex IP rules could deter participation from smaller entities or slow down the dissemination of critical research findings, potentially hindering the center's overall objectives of accelerating innovation.
Estimated impact: Significant impact on the terms of collaboration and commercialization of technologies developed at the center, affecting researchers, universities, and private companies.