Congress Joins The Biomanufacturing Onshoring Party

In mid-November 2025, Congress introduced the Biomanufacturing Excellence Act of 2025 (H.R. 6089) to establish a dedicated national center aimed at strengthening U.S. capacity for biopharmaceutical manufacturing. The bipartisan bill signals a material alignment with the current administration's onshoring and domestic innovation-fostering policy and presents meaningful scale-up opportunities for drug, device, and human-cell/tissue product sponsors that are part of institutions or public-private partnerships.

Bill overview & policy context

H.R. 6089 would amend the National Institute of Standards and Technology (NIST) Act to establish a National Biopharmaceutical Manufacturing Center of Excellence (COE) under NIST via competitive grants or other transaction agreements. The bill at the outset emphasizes biotechnology's role in national security, health-security, and supply-chain resilience. Through the COE, the bill targets: (i) demonstration of flexible and multi-platform manufacturing technologies; (ii) improvements in upstream/downstream processes; (iii) standardization of quality and controls (CMC/CMC-type efforts); and (iv) workforce training and collaborations across academia, industry and government.

The timing of the bill aligns with broader administration themes around American competitiveness in biotechnology, domestic supply-chain resilience, and advanced manufacturing. The bill was captioned by sponsors as a bipartisan lever to reduce dependence on foreign biomanufacturing, notably from rival jurisdictions, and to transition innovations from "lab to manufacturing" at scale.

Intersection with FDA regulatory policy

H.R. 6089 very clearly dovetails with ongoing FDA initiatives around modernizing manufacturing — e.g., the Agency's emphasis on Quality by Design (QbD), advanced manufacturing, continuous manufacturing, modular facilities, and flexible manufacturing platforms for biologics and cell/tissue products. The bill's focus on standardization of chemistry/manufacturing/controls and support for Good Manufacturing Practices (GMP) directly touches the regulatory controls that sponsors must meet.

For institutional or public-private partnership sponsors of biologics, regenerative therapies, and human cell/tissue products, the COE could provide a venue for "scale-up" validation under realistic conditions in collaboration with regulatory and industry stakeholders, thereby smoothing the pathway from innovation to commercial-scale manufacturing. Furthermore, the public-private collaboration may inform future FDA guidance around advanced manufacturing modalities, shaping how regulators view process improvements, platform technologies and supply-chain resilience.

Potential benefits for the U.S. life-sciences market

For the U.S. market, the benefits of the bill are myriad. First, the bill would strengthen domestic biomanufacturing infrastructure enhances supply-chain resilience — a growing regulatory and commercial imperative triggered by recent disruptions and global competition. Second, the COE aims to foster innovation by providing a laboratory-to-pilot-to-manufacturing bridge which may reduce risk and cost for sponsors, accelerating commercialization of biologics, cell/gene therapies, and other novel therapeutic modalities. Third, by bolstering workforce development and public-private collaboration, the bill supports the ability of U.S. sponsors and manufacturers to remain globally competitive, potentially attracting investment and leading to job creation within the biotech ecosystem. Finally, for patients and public health, more efficient translation of breakthrough therapies into accessible manufactured product could aid the broader societal goal of faster and more robust access to next-generation treatments.

Concluding thoughts

H.R. 6089 will be one to watch closely. While still at the introduction stage, the bill's enactment could shift some early stage manufacturing-scale regulatory strategy development, change sponsor engagement with regulators on novel processes, and modify manufacturing innovation integration into regulatory submissions. Organizations that might be impacted by this should consider whether manufacturing strategies, modular capacity planning, and process-development investments align with the COE's likely focus areas. In this regard, the bill may mark a key inflection point linking manufacturing-innovation policy, regulatory strategy, and competitive positioning in the U.S. biotech market.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.