S. 3188: Biomanufacturing Excellence Act of 2025

The Biomanufacturing Excellence Act of 2025 proposes the establishment of a National Biopharmaceutical Center of Excellence aimed at enhancing biopharmaceutical manufacturing in the United States. This bill recognizes the crucial role of biotechnology in various sectors, including national security and healthcare. Here’s a breakdown of the key components of the bill:

Findings and Purpose

Congress finds that:

• Biotechnology allows for the engineering of biological systems to create medicines, improve agricultural resilience, and develop materials.
• Countries that advance in biotechnology will shape global technological capabilities.
• Biopharmaceutical manufacturing can lead to better treatments and reduce reliance on foreign supply chains.
• U.S. manufacturers face challenges in scaling and profitably commercializing their innovations, necessitating more flexible and affordable production infrastructure.

Center of Excellence Establishment

The bill mandates the appointment of a Director to oversee the establishment of the National Biopharmaceutical Manufacturing Center of Excellence, which will:

• Encourage advances in biopharmaceutical manufacturing, specifically for products vital to national interests.
• Support good manufacturing practices and develop improved biopharmaceutical manufacturing technologies.
• Enhance workforce training and collaboration among government agencies, educational institutions, and the private sector.

Funding and Grants

The Center of Excellence will receive funding to:

• Construct necessary facilities for biopharmaceutical manufacturing.
• Conduct research on innovative manufacturing technologies.
• Develop worker training programs in biomanufacturing.
• Support research programs for improving biopharmaceutical manufacturing.

Competitive grants will be available for eligible entities, which include public-private partnerships and academic institutions, to apply for resources to establish and run the Center of Excellence.

Reporting and Oversight

The Director is tasked with producing several reports on the Center's activities, partnerships, and progress:

• An initial report one year after the establishment of the Center.
• A progress report one year into operations.
• A final report five years after operations commence.

Intellectual Property Guidelines

Before starting operations, the Center must establish intellectual property guidelines for research conducted in collaboration with it, ensuring proper management of innovations developed within the Center.

Funding Authorization

The legislation authorizes $120 million for the fiscal year 2026 to support the objectives of the Center of Excellence.

Definitions

The bill provides definitions for key terms such as:

• Biomanufacturing: Applying biotechnology to manufacturing processes.
• Biopharmaceutical: Pharmaceuticals produced using living cells or biological systems.
• Biotechnology: The application of science to living organisms or their components.

Relevant Companies

None found.