BIOSECURE Act: What Does It Mean for Your Nanoparticle Supply Chain?

BIOSECURE is changing how biotechnology companies evaluate suppliers, particularly for programs involving federal contracts, grants, or loans.

For nanoparticle buyers, the issue goes beyond knowing who sells the material. You need visibility into where critical products are manufactured, which companies perform key processing steps, and how difficult a supplier change would be if requirements shift.

What Does the BIOSECURE Act Do?

The BIOSECURE Act became law on December 18, 2025 as part of the FY2026 National Defense Authorization Act. It restricts federal agencies from procuring covered biotechnology equipment or services from designated biotechnology companies of concern and extends to certain federally funded contracts, grants, and loans.

Implementation is being phased in. The Office of Management and Budget must publish an initial list of biotechnology companies of concern by December 18, 2026, with procurement restrictions taking effect through the federal acquisition rulemaking process.

Applicability will depend on the product, service, funding source, and final implementing rules. Legal and procurement teams should evaluate requirements for their specific programs.

What Should You Review in Your Nanoparticle Supply Chain?

Start with manufacturing location. A U.S. distributor or sales office doesn't necessarily mean the nanoparticles themselves are produced domestically.

Ask where synthesis, purification, functionalization, conjugation, testing, and other critical steps take place. Understand which activities happen in-house, what is outsourced, and whether your supplier can identify important subcontractors or dependencies when needed.

Also consider whether the supplier can support your expected production scale. Once a nanoparticle becomes part of an established assay, formulation, device, or manufacturing process, changing sources can require significant technical work.

Why Nanoparticle Supplier Changes Can Be Difficult

Nominal specifications don't always capture the properties that determine nanoparticle performance. Materials with the same stated composition and diameter can differ in size distribution, morphology, surface chemistry, ligand density, aggregation state, residual impurities, or optical properties.

A supplier change may require new characterization, comparability studies, application testing, updated documentation, or process redevelopment. Custom materials can also require technology transfer.

Identifying supply-chain risks early gives your team more options before a sourcing issue affects development or production.

How nanoComposix Supports Your Supply Chain

nanoComposix is BIOSECURE Act compliant and develops and manufactures nanoparticles in San Diego, California. Core development, process scale-up, manufacturing, and extensive nanoparticle characterization capabilities are available within our U.S.-based operation.

For programs that move beyond standard catalog materials, our custom nanoparticle development and CDMO teams can support the path from early feasibility through large-scale manufacturing. Keeping development and production within the same organization also reduces the need for later technology transfer.

nanoComposix maintains an ISO 13485:2016-certified quality management system, with additional quality and manufacturing controls available for applicable regulated programs.

BIOSECURE implementation will continue to evolve, but supply-chain visibility is useful now. Understanding where critical materials are made, who performs key processing steps, and how easily a supplier could be replaced can reduce risk as your program advances.

BIOSECURE requirements continue to be implemented. Consult your legal or procurement team to determine how the law applies to your specific contracts, funding, products, and suppliers.