{
  "abstract": "There is growing interest in mesenchymal stromal cell-derived extracellular vesicles (MSC-EVs) as key components in the development of next-generation regenerative cell-free therapies; however, their clinical translation remains limited by a lack of validated clinical-grade manufacturing platforms. Thus, we have established a good manufacturing practice (GMP)-compliant, semi-automated, mid-scale manufacturing workflow that couples the single-use stirred-tank bioreactor expansion of Wharton's jelly-derived MSCs with tangential flow filtration and automated size-exclusion chromatography, featuring in-line monitoring of critical process parameters. The MSC-EV-based product meets pre-specified critical quality attributes (CQAs), co-expresses parental-cell- and EV-specific markers, and complies with standardized quality and safety regulations. Moreover, the final product CQAs-including CD73-associated immunomodulatory activity-remained within acceptable limits for 12 months of storage in PlasmaLyte 148 at -80°C. Overall, our integrated platform yields MSC-EVs with high batch-to-batch reproducibility, in alignment with current GMP and regulatory standards, thereby providing a robust foundation supporting their potential clinical applicability.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": "Article",
  "arxiv": null,
  "author_total": 16,
  "authors": [
    {
      "name": "Yvan Courageux"
    },
    {
      "name": "Marta Monguió-Tortajada"
    },
    {
      "name": "Alba López-Fernández"
    },
    {
      "name": "Leonie Schoch"
    },
    {
      "name": "Francesc Poblador"
    },
    {
      "name": "Sara Morini"
    },
    {
      "name": "Cristina Prat-Vidal"
    },
    {
      "name": "Luciano Rodriguez"
    },
    {
      "name": "Silvia Torrents"
    },
    {
      "name": "Gemma Aran"
    },
    {
      "name": "Margarita Codinach"
    },
    {
      "name": "Carolina Gálvez-Montón"
    },
    {
      "name": "Antoni Bayes-Genis"
    },
    {
      "name": "Joaquim Vives"
    },
    {
      "name": "Sergi Querol",
      "orcid": "0000-0002-1105-8633"
    },
    {
      "name": "Santiago Roura",
      "orcid": "0000-0003-4063-9661"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/29vn8w7zgwybs.bib",
  "cited_by": 0,
  "doi": "10.1016/j.isci.2026.117881",
  "fulltext_url": "https://europepmc.org/articles/PMC13694818",
  "id": "29vn8w7zgwybs",
  "issns": [
    "2589-0042"
  ],
  "landing_url": "https://www.cell.com/iscience/fulltext/S2589-0042(26)03264-5",
  "language": "eng",
  "licence": "CC-BY-NC-ND-4.0",
  "licence_label": "CC BY-NC-ND 4.0",
  "licence_source": "article",
  "licence_url": "http://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Biotechnology"
    ],
    [
      "openalex",
      "1312|Extracellular vesicles in disease"
    ]
  ],
  "openalex": "W7221857383",
  "pdf_url": "https://europepmc.org/articles/PMC13694818?pdf=render",
  "pmcid": "PMC13694818",
  "pmid": "42926845",
  "published": "2026-10-15",
  "publisher": "Elsevier BV",
  "ris": "https://research.draconitic.com/paper/29vn8w7zgwybs.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:17:16Z",
      "native_id": "10.1016/j.isci.2026.117881",
      "source": "feed-cell",
      "url": "https://www.cell.com/iscience/fulltext/S2589-0042(26)03264-5"
    },
    {
      "first_seen": "2026-10-30T12:17:49Z",
      "native_id": "10.1016/j.isci.2026.117881",
      "source": "crossref",
      "url": "https://linkinghub.elsevier.com/retrieve/pii/S2589004226032645"
    },
    {
      "first_seen": "2026-10-30T12:21:18Z",
      "native_id": "MED:42926845",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42926845"
    }
  ],
  "subjects": [
    {
      "field": "biology",
      "origin": "heading:Biotechnology",
      "subfield": "systems-synthetic"
    }
  ],
  "title": "Design and validation of a GMP-compliant manufacturing platform of extracellular vesicles from mesenchymal stromal cells",
  "title_text": "Design and validation of a GMP-compliant manufacturing platform of extracellular vesicles from mesenchymal stromal cells",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:21:18Z",
  "url": "https://research.draconitic.com/paper/29vn8w7zgwybs",
  "venue": "iScience",
  "versions": []
}