Current Status of PRP Manufacturing Requirements & European Regulatory Frameworks: Practical Tools for the Appropriate Implementation of PRP Therapies in Musculoskeletal Regenerative Medicine.

Détails

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Etat: Public
Version: de l'auteur⸱e
Licence: CC BY 4.0
ID Serval
serval:BIB_272C3A91FB7F
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Current Status of PRP Manufacturing Requirements & European Regulatory Frameworks: Practical Tools for the Appropriate Implementation of PRP Therapies in Musculoskeletal Regenerative Medicine.
Périodique
Bioengineering
Auteur⸱e⸱s
Sebbagh P., Cannone A., Gremion G., Gremeaux V., Raffoul W., Hirt-Burri N., Michetti M., Abdel-Sayed P., Laurent A., Wardé N., Applegate L.A.
ISSN
2306-5354 (Print)
ISSN-L
2306-5354
Statut éditorial
Publié
Date de publication
24/02/2023
Peer-reviewed
Oui
Volume
10
Numéro
3
Pages
292
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: epublish
Résumé
Providing accurate and up-to-date practical tools enabling oversight of platelet-rich plasma (PRP) legislation and of the appropriate standards to be implemented for its manufacture and use in Europe is a demanding task. This is due to rapid medico-technological advancements, slowness and disparity in legislation updates and enforcement between member states, and many reported gray-zone practices, notably for autologous PRP use. The levels of risk associated with blood manipulation processes generally dictate the manufacturing requirements for PRP preparations, which have gradually shifted toward good manufacturing practices (GMP) for standardization and overall quality enhancement. This work firstly outlines Western European and Swiss legislation for PRP products/preparations, providing key simplified information and recommendations for medical doctors seeking to implement this biological-based therapy for safe use in hospital settings, clinics, or private offices. This work secondly shows the importance of PRP-based product manufacturing standardization, which subsequently enables sound clinical evaluation of therapeutic interventions. Although the applicable legal bases provide guidelines for GMP manufacturing infrastructure and basic process design, paramount importance is set on the definition of workflows, technical specifications, and key parameters for PRP preparation and delivery. Overall, the development of simple and robust technologies and processes for PRP preparation is critical for guaranteeing the high therapeutic quality of the intervention, in collaboration with qualified GMP manufacturing platforms. Importantly, this work aims to serve as a practical tool for clinicians based in Western Europe who are willing to appropriately (i.e., administratively and technically) implement autologous PRP treatments in musculoskeletal regenerative medicine workflows, to ensure they make informed and optimal regulatory or process-based decisions.
Mots-clé
biologicals, clinical cytotherapies, good manufacturing practices, musculoskeletal affections, orthobiologics, platelet-rich plasma, process standardization, regenerative medicine, regulatory frameworks, therapeutic products
Pubmed
Web of science
Open Access
Oui
Création de la notice
03/04/2023 10:34
Dernière modification de la notice
19/07/2023 5:57
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