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Expert Revision of Key Elements for Clinical-Grade Production and Qualification of Perinatal Derivatives

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  • Additional Information
    • Contributors:
      Karolinska Institutet Stockholm; Karolinska University Hospital Stockholm; Universidad de Murcia; Institut Ruđer Bošković (IRB); Biomatériaux et inflammation en site osseux - EA 4691 (BIOS); Université de Reims Champagne-Ardenne (URCA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-SFR CAP Santé (Champagne-Ardenne Picardie Santé); Université de Reims Champagne-Ardenne (URCA)-Université de Reims Champagne-Ardenne (URCA); Life Sciences Center Vilnius, Lithuania; Laboratoire Réactions et Génie des Procédés (LRGP); Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS); Oslo University Hospital Oslo; Institute of Molecular Biology and Genetics of NAS of Ukraine; National Academy of Sciences of Ukraine = Національна академія наук України = Académie nationale des sciences d'Ukraine (NASU / НАН України); Etablissement Français du Sang Nouvelle Aquitaine Bordeaux (EFS Bordeaux Nouvelle Aquitaine); Laboratoire Maladies Rares: Génétique et Métabolisme (Bordeaux) (U1211 INSERM/MRGM); Université de Bordeaux (UB)-Groupe hospitalier Pellegrin-Institut National de la Santé et de la Recherche Médicale (INSERM); Instituto Murciano de Investigación Biosanitaria Pascual Parrilla (IMIB); Service de Chirurgie Orthopédique Traumatologique et Plastique Besançon; Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC); Université Bourgogne Franche-Comté COMUE (UBFC)-Université Bourgogne Franche-Comté COMUE (UBFC); Université Bourgogne Franche-Comté COMUE (UBFC); Nanomédecine, imagerie, thérapeutique - UFC (UR 4662) (NIT / NANOMEDECINE); Université de Franche-Comté (UFC)
    • Publication Information:
      CCSD
      Wiley
    • Publication Date:
      2024
    • Collection:
      Université de Reims Champagne-Ardenne: Archives Ouvertes (HAL)
    • Abstract:
      International audience ; Abstract Perinatal derivatives have been proposed as adjunct therapeutic strategies or innovative treatments. Undoubtedly, perinatal derivatives can offer the opportunity and source material to isolate multipotent stem cells, but both maternal- and fetal-derived tissues can be processed and transformed into engineered tissues or advanced biomedical devices, whose potential remains to be fully elucidated. Promising preclinical and clinical results collected so far clearly foresee an escalation of such novel treatments. Market forecasts predict exponential growth in such advanced medicinal products during the next decade, with a pragmatic innovation for medicine into a more advanced biomedical version, enlarging the portfolio for treating a wide range of congenital and acute conditions. However, all these promising and fascinating therapeutic possibilities cannot gain a solid and recognized role in established medical practice without rigid and harmonized manufacturing strategies. The implementation of strategies according to guidelines and directives compiled by Regulatory Agencies, in conformity to (European) Pharmacopoeia and for Good Manufacturing Practice -conforming production of such products, represent critical steps required to translate perinatal technologies into effective therapeutic approaches. During the past 5 years, a panel of European experts and developers, gathered under the umbrella of the COST Sprint Action, supported by the European Cooperation in Science and Technology action, had the opportunity to revise and summarize experience and recommendations for a fruitful and proficient generation of perinatal biomedical products. In order to facilitate the creation and potential commercialization of perinatal bioengineered and advanced pharmaceutical products and technologies, such a collection of data and recommendations is described and discussed here.
    • Accession Number:
      10.1093/stcltm/szad068
    • Online Access:
      https://hal.science/hal-04761176
      https://hal.science/hal-04761176v1/document
      https://hal.science/hal-04761176v1/file/Gramonili%202024.pdf
      https://doi.org/10.1093/stcltm/szad068
    • Rights:
      http://creativecommons.org/licenses/by/ ; info:eu-repo/semantics/OpenAccess
    • Accession Number:
      edsbas.33FE6B14