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

Details

Ressource 1Request a copy Under indefinite embargo.
UNIL restricted access
State: Public
Version: author
License: CC BY 4.0
Serval ID
serval:BIB_272C3A91FB7F
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Current Status of PRP Manufacturing Requirements & European Regulatory Frameworks: Practical Tools for the Appropriate Implementation of PRP Therapies in Musculoskeletal Regenerative Medicine.
Journal
Bioengineering
Author(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
Publication state
Published
Issued date
24/02/2023
Peer-reviewed
Oui
Volume
10
Number
3
Pages
292
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
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.
Keywords
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
Yes
Create date
03/04/2023 11:34
Last modification date
19/07/2023 6:57
Usage data