Supporting common international standards for DNA synthesis screening
IBBIS seeks to support standards for DNA synthesis screening that are international, inclusive and rigorous. There has been increasing interest in harmonizing and standardizing screening approaches around the world, especially in light of national and international guidance released in 2024 and concerns that advances in artificial intelligence will increase the risk that synthetic nucleic acids are misused. By promoting and enhancing emerging standards, we aim to prevent fragmentation of synthesis screening methodology while improving baseline practices.
Challenge: a fragmented landscape of voluntary guidance
Voluntary standards for sequence and customer screening have already been adopted by providers aiming to comply with their national export controls and biosecurity guidance. However, this adoption remains uneven, particularly among smaller providers. In the past few years, there has been increasing interest in harmonizing and standardizing screening practices from industry and the international organizations:
- The International Gene Synthesis Consortium (IGSC) has grown to over 40 members, all of whom agree to screen orders according to a Harmonized Screening Protocol
- Over 175 developers of AI for biodesign have signed the Commitments for the Responsible Development of AI for Protein Design, including the commitment to “obtain DNA synthesis services only from providers that demonstrate adherence to industry-standard biosecurity screening practices”
- The 2022 WHO Global guidance framework for the responsible use of the life sciences includes a scenario in which synthetic nucleic acids are used to produce a chimeric virus, and highlights how biosecurity risks could have been avoided if the synthesis company had screened the order
- ISO 20688-2:2024, a standard for production and quality control of synthesized gene fragments, genes, and genomes, includes biosecurity provisions related to synthesis screening
Policymakers have begun to formalize and clarify these voluntary standards, including under the 2023 U.S. Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids and 2024 U.K. Screening guidance on synthetic nucleic acids for users and providers, which references ISO 20688-2. If attention is not given to a harmonised approach, this formalization risks creating an even more fragmented landscape, complicating compliance and placing responsible companies at a competitive disadvantage.
Our Work: promoting and strengthening international screening standards
IBBIS is bringing together industry, government, and scientific experts from around the world to support common international standards for DNA synthesis screening. Our core efforts include:
- Strengthening Screening Standards: Enhancing ISO 20688-2, closing gaps in risk assessment, and developing clear, practical screening guidelines
- Promoting Universal Adoption: Engaging industry, policymakers, and regulators to drive adherence and integrate biosecurity into procurement and licensing
- Strengthening International Coordination: Aligning stakeholders, ensuring standards evolve with new technologies, and fostering public-private partnerships
IBBIS is well-positioned to promote these standards due to our focus on implementation, global convening power, and ongoing efforts in synthesis screening. This project connects to our efforts to close information gaps through the Global Synthesis Map and create an accessible screening tool through the Common Mechanism, while involving more direct engagement with national standards bodies around the world.
Project Timeline
- January 2025 | Project kickoff, stakeholder outreach begins
- Mid-2025 | Engagement with industry, policymakers, and biosecurity experts to identify gaps in existing frameworks
- Late 2025 | Development of technical recommendations to strengthen international standards (e.g. ISO 20688-2) and pilot testing with select gene synthesis providers
Team
Project Lead
Sophie Peresson