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Risks and capability

Four synthetic biology risk objects open the portfolio. Order carries no rank. Each is read across driver, exposure, vulnerability, capacity, cascade and consequence.

6 min read0 figures1 table23 notesNR-XTECH-SYNBIO-GLOBAL-2026-BASELINE

Contents
  1. ·Edition home
  2. ·Executive summary
  3. 1Synthetic biology is a build capability and a governance test
  4. 2Key findings
  5. 3Systems and sectors at baseline
  6. 4Risks and capability
    1. 4.1 Risk objects
    2. 4.2 Capability ladder
  7. 5Design capability outpaces screening and oversight
  8. 6Readings from the other desks
  9. 7The 2027 agenda
  10. 8Systems in depth
  11. AMethodology
  12. BData appendix
  13. CReferences and record
  14. ·Complete edition, for print

4.1Risk objects

Each risk is read across the chain from hazard to consequence, with its status and evidence-quality level.

  1. InferredEQL 3RSK-XT04-SEC-001

    Design capability outpaces screening

    Driver
    open machine-learning design tools and low-cost DNA713
    Exposure
    sequence-handling and synthesis providers
    Vulnerability
    uneven screening practice; benchtop and small providers
    Capacity
    screening guidance, patches and oversight frameworks13253132
    Cascade
    DAT → BIO → HLT
    Horizon
    1 to 5 years

  2. InferredEQL 3RSK-XT04-GOV-002

    Fragmented and shifting oversight

    Driver
    unclear status of the US framework; separate EU and CBD tracks20222627
    Exposure
    research collaboration; cross-border orders
    Vulnerability
    uneven implementation across jurisdictions18
    Capacity
    OECD and WHO guidance; national strategies1821
    Cascade
    GOV → BIO, FIN
    Horizon
    1 to 5 years

  3. Expert inputEQL 2RSK-XT04-SUP-003

    Manufacturing base thinner than headlines

    Driver
    mixed company results and planning-stage public awards161724
    Exposure
    products that depend on scale-up
    Vulnerability
    few counted facilities; unmeasured feedstock needs
    Capacity
    institute and awards programme2324
    Cascade
    FIN → INF → BIO
    Horizon
    1 to 10 years

  4. InferredEQL 2RSK-XT04-ENV-004

    Release and novel-organism questions

    Driver
    gene drives and organisms with altered codes or chirality11112
    Exposure
    ecosystems; public trust
    Vulnerability
    limited field evidence; international rules still forming
    Capacity
    CBD process and protocol2035
    Cascade
    BIO → BIO biodiversity systems
    Horizon
    5 to 10 years

4.2Capability ladder

Existence is not readiness. Each of the fifteen capability functions is placed on the ladder by the strongest public evidence for synthetic biology at the global level.

Table 4.1Capabilities on the ladder of evidence: listed, exists, demonstrated, tested
FunctionRungLevelStrongest public evidence at baseline
Prevention and mitigationEXISTSscreening guidance and dual-use frameworks published212531
Monitoring and observationLISTEDno common tracker of synthesis orders or screening coverage
Early warningLISTEDhorizon scanning exists under the CBD but is scaled back20
Preparedness and planningEXISTSUS commission report, EU proposal and OECD papers141822
Redundancy and reservesLISTEDmanufacturing capacity and reserves not counted
ResponseLISTEDno tested response to a misuse event described in the sources
Continuity of critical servicesLISTEDnot reviewed
RecoveryLISTEDnot applicable at baseline; no event to recover from
AdaptationEXISTSanticipatory governance principles in OECD work1819
Social protectionLISTEDnot applicable at baseline
Finance and insuranceLISTEDpublic and private investment not on a common basis
Institutional coordinationEXISTSWHO, CBD and OECD processes182021
Technical infrastructureEXISTSbioindustrial institute and planning awards2324
WorkforceLISTEDskills gaps reported in policy documents; no figure bound
Research capacityADEQUATEstrong peer-reviewed base1467
A capability listed in policy is not a tested one; each rung is the strongest public evidence at baseline.

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

  1. 7Watson, J.L. et al., De novo design of protein structure and function with RFdiffusion, Nature 620, 1089 to 1100, 2023 (record read via Europe PMC). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back
  2. 13Strengthening nucleic acid biosecurity screening against generative protein design tools, Science 390 (6768), 82 to 87, 2025 (record read via Europe PMC; abstract only; no method detail used). American Association for the Advancement of Science, Washington. Observation year 2025. Accessed 2026-11-03.back
  3. 25UNVERIFIED, not opened: Office of Science and Technology Policy (ed.), Framework for Nucleic Acid Synthesis Screening, April 2024, taken from search-result summaries; a fetch of the page was refused by the fetch tool. OSTP, Washington. Observation year 2024. Accessed 2026-11-03.back
  4. 31UNVERIFIED, not opened: International Gene Synthesis Consortium (ed.), Harmonized Screening Protocol, cited from memory. IGSC. Observation year 2024. Accessed 2026-11-03.back
  5. 32UNVERIFIED, not opened: UK Government (ed.), screening guidance on synthetic nucleic acids, 2024, cited from memory. Department for Science, Innovation and Technology, London. Observation year 2024. Accessed 2026-11-03.back
  6. 20Secretariat of the Convention on Biological Diversity (ed.), Synthetic biology (programme page; decisions X/13 to 16/21; AHTEG; horizon scanning; thematic action plan). CBD Secretariat, Montreal. Observation year 2026. Accessed 2026-11-03.back
  7. 22Baker McKenzie (ed.), EU Biotech Act unveiled: Commission proposal to turn Europe into a biotech powerhouse (law firm summary, 19 December 2025; proposal of 16 December 2025; health focus; investment pilot with the European Investment Bank Group; 12-month certificate extension; biodefence measures; second act expected in Q3 2026). Secondary source, not the Commission text. Observation year 2025. Accessed 2026-11-03.back
  8. 26UNVERIFIED, not opened: Executive Order 14292, Improving the Safety and Security of Biological Research, 5 May 2025 (90 days to revise or replace the framework), taken from search-result summaries; a fetch of an explainer page was refused by the fetch tool. The White House, Washington. Observation year 2025. Accessed 2026-11-03.back
  9. 27UNVERIFIED, not opened: Congressional Research Service (ed.), report on artificial intelligence and biosecurity risks (reported in July 2026 as unable to determine whether the 2024 framework or the 2025 policy had been revised), taken from a trade news summary. Library of Congress, Washington. Observation year 2026. Accessed 2026-11-03.back
  10. 18OECD (ed.), Anticipatory governance for responsible innovation in synthetic biology, OECD Science, Technology and Industry Policy Papers No. 193, 21 May 2026 (record read via a bibliographic database; abstract only). OECD Publishing, Paris. Observation year 2026. Accessed 2026-11-03.back
  11. 21World Health Organization (ed.), Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (publication page, 13 September 2022). WHO, Geneva. Observation year 2022. Accessed 2026-11-03.back
  12. 16Twist Bioscience Corporation (ed.), Form 8-K exhibit 99.1, results for the fiscal third quarter ended 30 June 2026 (company filing; revenue USD 118.4 million; nine months USD 332.8 million; fiscal 2026 guidance USD 456 to 457 million; company statements and guidance are weak evidence). US Securities and Exchange Commission, Washington. Observation year 2026. Accessed 2026-11-03.back
  13. 17Ginkgo Bioworks Holdings, Inc. (ed.), Form 8-K exhibit 99.1, fourth quarter and full year 2025 results (company filing of 26 February 2026; revenue USD 170.155 million against USD 227.043 million; net loss USD 312.763 million; company statements are weak evidence). US Securities and Exchange Commission, Washington. Observation year 2025. Accessed 2026-11-03.back
  14. 24US Manufacturing Program (ed.), Bioindustrial (programme topic page; Distributed Bioindustrial Manufacturing Program awards announced 10 July to 13 September 2024; 25 awards; USD 42 million cumulative). Manufacturing USA, Gaithersburg. Observation year 2024. Accessed 2026-11-03.back
  15. 23BioMADE (ed.), DoD approves USD 87 million for newest bioindustrial manufacturing innovation institute (news page; seven years; the page shows Oct 20 and a 2023 footer, the press release is dated 2020 in search listings). BioMADE, Saint Paul. Observation year 2020. Accessed 2026-11-03.back
  16. 1Robertson, W.E. et al., Escherichia coli with a 57-codon genetic code, Science 390 (6771), eady4368, published 23 October 2025 (record read via PubMed, PMID 40743368; the record gives a 4 megabase synthetic genome and six replaced sense codons). American Association for the Advancement of Science, Washington. Observation year 2025. Accessed 2026-11-03.back
  17. 11Kyrou, K. et al., A CRISPR-Cas9 gene drive targeting doublesex causes complete population suppression in caged Anopheles gambiae mosquitoes, Nature Biotechnology 36, 1062 to 1066, 2018 (record read via Europe PMC; laboratory cages only). Springer Nature, London. Observation year 2018. Accessed 2026-11-03.back
  18. 12Confronting risks of mirror life, Science 386, 1351 to 1353, 2024 (record read via Europe PMC; the record gives only a one-line abstract calling for broad discussion). American Association for the Advancement of Science, Washington. Observation year 2024. Accessed 2026-11-03.back
  19. 35UNVERIFIED, not opened: Cartagena Protocol on Biosafety to the Convention on Biological Diversity, 2000, cited from memory. CBD Secretariat, Montreal. Observation year 2000. Accessed 2026-11-03.back
  20. 14Congressional Research Service (ed.), National Security Commission on Emerging Biotechnology: Final Report and Options for Congress, CRS Insight IN12546, 17 April 2025 (report of 8 April 2025; 49 recommendations; at least USD 15 billion over five years; National Biotechnology Coordination Office). Library of Congress, Washington. Observation year 2025. Accessed 2026-11-03.back
  21. 19OECD (ed.), Synthetic biology, AI and automation: a forward-looking technology assessment, OECD Science, Technology and Industry Policy Papers No. 187, 4 December 2025 (record read via a bibliographic database; abstract only). OECD Publishing, Paris. Observation year 2025. Accessed 2026-11-03.back
  22. 4Debugging and consolidating multiple synthetic chromosomes reveals combinatorial genetic interactions, Cell 186 (24), 5220 to 5236, 2023 (record read via Europe PMC: 6.5 synthetic chromosomes in one strain; over half of the Sc2.0 genome). Cell Press, Cambridge, Massachusetts. Observation year 2023. Accessed 2026-11-03.back
  23. 6Nielsen, A.A.K. et al., Genetic circuit design automation, Science 352 (6281), 2016 (record read via Europe PMC: 60 circuits; 45 correct in all output states; 92% of output states as predicted). American Association for the Advancement of Science, Washington. Observation year 2016. Accessed 2026-11-03.back

Cite this chapter

Valadbaygi, S. (Ed.). (2026). Chapter 4: Risks and capability. In Exponential Technology Report 2026: Synthetic Biology and Bioengineering (Baseline Edition 2026, Report No. NR-XTECH-SYNBIO-GLOBAL-2026-BASELINE) [Draft under review]. The Global Centre for Risk and Innovation (GCRI).

Every citation form of the whole report, BibTeX and RIS included, is on the edition home. Cite this report

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