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Expert Revision of Key Elements for Clinical-Grade Production and Qualification of Perinatal Derivatives
LAFARGE, Xavier
Composantes innées de la réponse immunitaire et différenciation [CIRID]
Biothérapies des maladies génétiques et cancers
Laboratoire Maladies Rares: Génétique et Métabolisme (Bordeaux) [U1211 INSERM/MRGM]
Etablissement Français du Sang Nouvelle Aquitaine [Bordeaux] [EFS Bordeaux Nouvelle Aquitaine]
< Réduire
Composantes innées de la réponse immunitaire et différenciation [CIRID]
Biothérapies des maladies génétiques et cancers
Laboratoire Maladies Rares: Génétique et Métabolisme (Bordeaux) [U1211 INSERM/MRGM]
Etablissement Français du Sang Nouvelle Aquitaine [Bordeaux] [EFS Bordeaux Nouvelle Aquitaine]
Langue
EN
Article de revue
Ce document a été publié dans
Stem Cells Translational Medicine. 2024-01-12, vol. 13, n° 1, p. 14-29
Résumé en anglais
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 ...Lire la suite >
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.< Réduire
Mots clés en anglais
Advanced Medical Device
Atmp
Cell Therapy
European Regulation
Perinatal Derivatives
Placenta
Unités de recherche