White Paper: A Proposal for Biodesign Metadata Exchange for Use in Biosecurity

Accelerating advances in biodesign offer significant potential societal benefits, including advancing public health through the development of new vaccines and treatments. However, these advances also pose growing biosecurity risks, particularly, the accidental or intentional creation of harmful biological agents.

Current biosecurity frameworks, such as those used by the International Gene Synthesis Consortium, rely on the ability to compare DNA synthesis orders to known sequences to determine if they may be concerning. However, as biodesign tools—especially those powered by artificial intelligence (AI)—begin exploring novel biological designs that deviate substantially from organisms found in nature, traditional screening methods are likely to struggle to interpret these novel designs.  This makes it difficult for DNA synthesis providers and other service providers, who support bioscience and biotechnology research and development, to detect potential threats, as it involves assessing the risks of entirely new designs that do not resemble known organisms or toxins.

To address these challenges, NTI | bio partnered with Lattice Automation to design and pilot a standard for capturing and transmitting metadata—such as design provenance, editing history, and intended use—alongside DNA or protein sequences. The additional context provided by this standard, known as the Biodesign Metadata Exchange (BMDE), can help biosecurity decision-makers assess risks more effectively by increasing their understanding of not only the sequence itself but also the design process behind it.

The report is divided into two sections:

• Section 1 provides a high-level introduction to the biodesign landscape, biosecurity challenges, and the purpose of the proposal. This section can help policymakers and biosecurity strategists understand the problem and the proposed solution in broad terms.

• Section 2 dives into the technical aspects of and potential use cases for the BMDE, covering the specifics of how metadata can be captured, transmitted, stored, and validated. This section is likely to be most useful for technical implementers and biosecurity practitioners who need detailed knowledge of how the standard works and how it can be applied.

The BMDE is one of the pilot projects recommended by NTI’s previous report on Developing Guardrails for AI Biodesign Tools. Building off the proposals in this report, NTI | bio and Lattice Automation will explore partnerships with biodesign tool developers and DNA synthesis providers to test, validate and promote broader adoption of the standard.