{
  "abstract": "Engineered live biotherapeutic products (LBPs) are viable microorganisms deliberately modified to perform a therapeutic function in a patient. Recombinant therapeutic strains are considered separately from conventional probiotics, donor-derived microbiota products, vaccines, living diagnostics, environmental systems, and systemically administered oncolytic bacteria. Selected oncology platforms share engineering constraints with LBPs, although their classification as LBPs depends on the specific therapy. The target product profile sets the niche, route, and exposure requirements against which chassis, genetic control, and payload release are assessed. Fitness costs, genetic stability, basal leakage, and clearance constrain circuit complexity. Formulation and manufacturing must preserve viability and mechanism-linked potency, with process control and independent containment layers evaluated quantitatively during development. Human studies of engineered metabolic strains support feasibility, short-term tolerability, clearance, and pharmacodynamic activity, although broad or durable clinical benefit has not yet been shown. Microbiota products approved by the U.S. Food and Drug Administration (FDA) provide regulatory precedents for live microbial medicines, with approval specific to each unengineered product. Clinical trials require separate assessment of target engagement and patient benefit.",
  "abstract_shown": true,
  "affiliations": [
    "Key Laboratory of Artificial Organs and Computational Medicine of Zhejiang Province, Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University",
    "State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, National Medical Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine"
  ],
  "article_type": "review article",
  "arxiv": null,
  "author_total": 3,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Sijia Shen"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Junsheng Zhao"
    },
    {
      "affs": [
        0
      ],
      "name": "Hainv Gao"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/58n91ktw812cb.bib",
  "cited_by": 0,
  "doi": "10.3389/fmicb.2026.2002085",
  "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13720282/?tool=EBI",
  "id": "58n91ktw812cb",
  "issns": [
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  "landing_url": "https://www.frontiersin.org/articles/10.3389/fmicb.2026.2002085/full",
  "language": "eng",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Review"
    ],
    [
      "openalex",
      "1305|Cancer Research and Treatments"
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  "openalex": "W7222502756",
  "pdf_url": "https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2026.2002085/pdf",
  "pmcid": "PMC13720282",
  "pmid": "42964597",
  "published": "2026-10-16",
  "publisher": "Frontiers Media SA",
  "ris": "https://research.draconitic.com/paper/58n91ktw812cb.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:12Z",
      "native_id": "10.3389/fmicb.2026.2002085",
      "source": "crossref",
      "url": "https://www.frontiersin.org/articles/10.3389/fmicb.2026.2002085/full"
    },
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      "first_seen": "2026-10-31T12:21:36Z",
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    },
    {
      "first_seen": "2026-11-03T12:21:12Z",
      "native_id": "PMC13720282",
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      "url": "https://doi.org/10.3389/fmicb.2026.2002085"
    }
  ],
  "subjects": [
    {
      "field": "biology",
      "origin": "openalex:1305|Cancer Research and Treatments",
      "subfield": "systems-synthetic"
    }
  ],
  "title": "Engineered live biotherapeutic products: design decisions, failure modes, and clinical translation",
  "title_text": "Engineered live biotherapeutic products: design decisions, failure modes, and clinical translation",
  "type": "peer-reviewed",
  "updated_at": "2026-11-03T12:21:12Z",
  "url": "https://research.draconitic.com/paper/58n91ktw812cb",
  "venue": "Frontiers in Microbiology",
  "versions": []
}