H.R. 6089: Biomanufacturing Excellence Act of 2025

This bill, titled the Biomanufacturing Excellence Act of 2025, is intended to enhance biopharmaceutical manufacturing in the United States by establishing a center of excellence dedicated to this field. Below are the key components of the bill:

Purpose

The primary purpose of the bill is to establish a National Biopharmaceutical Manufacturing Center of Excellence within the National Institute of Standards and Technology (NIST). This center aims to:

• Advance the science of biopharmaceutical manufacturing.
• Support good manufacturing practices and innovational quality standards.
• Facilitate collaboration among various stakeholders, including public, private, and nonprofit entities.
• Enhance workforce training and development specific to biopharmaceutical manufacturing.

Key Findings

The bill highlights several findings regarding biotechnology:

• Biotechnology can design and engineer biological systems for pharmaceuticals and other uses, allowing a range of applications.
• It has significant potential benefits for national security, health care, and economic resilience.
• Investments in biomanufacturing can reduce reliance on foreign supply chains and enhance production capabilities within the U.S.
• Current barriers include the need for scalable processes and affordable development infrastructure.

Center of Excellence Establishment

The Director of NIST is tasked with granting funds to establish and operate the Center of Excellence. The selection of an eligible entity to run the center will be based on competitive applications. Eligible entities include:

• Public-private partnerships
• Institutions of higher education
• Consortia of eligible entities

Operational Objectives

The Center of Excellence will focus on:

• Developing and demonstrating flexible manufacturing technologies.
• Supporting quality standards and regulation improvements in biopharmaceutical manufacturing.
• Training workforce in essentials of biopharmaceutical manufacturing.
• Collaborating with educational institutions, pharmaceutical manufacturers, and government agencies.

Funding and Oversight

The bill authorizes an appropriation of $120,000,000 for the fiscal year 2026 to support the center's establishment and operations. The Director will report to Congress on the progress of the center, including infrastructure development and collaborations, after various intervals:

• Initial report within one year of establishment
• Progress report one year after operations commence
• Final report five years after operations commence

Intellectual Property and Definitions

Prior to starting operations, the center must establish guidelines regarding intellectual property rights for any research conducted in collaboration with it. The bill provides definitions for terms such as biomanufacturing, biopharmaceutical, and biotechnology to clarify its scope.

Relevant Companies

• PFE (Pfizer Inc.) - As a leading biopharmaceutical company, Pfizer may benefit from new manufacturing processes and technologies developed through the proposed center.
• AMGN (Amgen Inc.) - Amgen, specializing in biotechnology medicines, could leverage improved manufacturing practices resulting from this bill.
• ABBV (AbbVie Inc.) - AbbVie focuses on biologics and may be directly impacted by advancements in biomanufacturing technologies promoted by the center.