Converging quality by design, artificial intelligence, and biofoundry automation: A new paradigm for scalable circular biomanufacturing

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dc.contributor.authorBelloch-Molina, Carlos
dc.contributor.authorda Silva, Francisco Vitor Santos
dc.contributor.authorMorrissey, John P.
dc.contributor.authorSousa Gallagher, Maria Jose
dc.contributor.funderTaighde Éireann - Research Ireland
dc.date.accessioned2026-09-16T13:19:01Z
dc.date.available2026-09-16T13:19:01Z
dc.date.issued2026-08-07
dc.description.abstractSynthetic biology applies engineering principles to the rational design of biological systems with the aim of producing predictable and tunable behaviour. Although the field’s conceptual foundations and core technologies are well established, the recent simultaneous maturation of Quality by Design (QbD), artificial intelligence (AI)-assisted biological design, and automated biofoundry workflows is beginning to outline a more replicable pathway from laboratory innovation to industrial-scale circular biomanufacturing. This review argues that the convergence of these three elements, rather than any one alone, characterises the current phase of the field. We examine how the Design-Build-Test-Learn (DBTL) cycle is being transformed from a research heuristic into a systematic industrial development framework; show how shared toolsets now transfer across microbial, plant, and animal systems to enable a holistic bioeconomy; benchmark synthetic biology-derived products against conventional alternatives where techno-economic and life-cycle data permit; and examine scale-up, regulatory, and societal bottlenecks through recent market-scale case studies in which these bottlenecks have been navigated in practice. We also contrast EU and US regulatory frameworks to show how policy divergence shapes technology adoption. We conclude by identifying what the coming decade of convergent synthetic biology must deliver to support a circular bioeconomy at the scale the 2030 Agenda demands.en
dc.description.sponsorshipResearch Ireland|GOIPG/2021/435
dc.description.versionPublished Version
dc.format.extent14
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid109001
dc.identifier.authororcidBelloch-Molina, Carlos
dc.identifier.authororcidda Silva, Francisco Vitor Santos§0000-0002-2360-1322
dc.identifier.authororcidMorrissey, John P.§0000-0001-7960-2001
dc.identifier.authororcidSousa Gallagher, Maria Jose§0000-0001-5290-8131
dc.identifier.citationBelloch-Molina, C, da Silva, F V S, Morrissey, J P & Sousa Gallagher, M J 2026, 'Converging quality by design, artificial intelligence, and biofoundry automation : A new paradigm for scalable circular biomanufacturing', Biotechnology Advances, vol. 92, 109001, pp. 1-14. https://doi.org/10.1016/j.biotechadv.2026.109001
dc.identifier.doi10.1016/j.biotechadv.2026.109001
dc.identifier.endpage14
dc.identifier.issn0734-9750
dc.identifier.otherORCID: /0000-0001-5290-8131/work/226977537
dc.identifier.otherORCID: /0000-0001-7960-2001/work/226978253
dc.identifier.otherORCID: /0000-0002-2360-1322/work/226978381
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/19261
dc.identifier.volume92
dc.language.isoen
dc.publisherElsevier Inc.
dc.relation.urihttps://www.scopus.com/pages/publications/105046562716
dc.rights© 2026 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ ).
dc.rights.accessrightsopen access
dc.rights.licensenameAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.statusPeer reviewed
dc.subjectArtificial intelligence
dc.subjectBioeconomy
dc.subjectBiofoundry
dc.subjectCircular biomanufacturing
dc.subjectDesign-Build-Test-Learn
dc.subjectPrecision fermentation
dc.subjectQuality by design
dc.subjectSynthetic biology
dc.subject[EngineeringArchitecture]
dc.titleConverging quality by design, artificial intelligence, and biofoundry automation: A new paradigm for scalable circular biomanufacturingen
dc.typeReview
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