dc.contributor.author | Stawarska, Agnieszka | |
dc.contributor.author | Bamburowicz-Klimkows, Magdalena | |
dc.contributor.author | Rundén-Pran, Elise | |
dc.contributor.author | Dusinska, Maria | |
dc.contributor.author | Cimpan, Mihaela Roxana | |
dc.contributor.author | Rios-Mondragon, Ivan | |
dc.contributor.author | Grudzinski, Ireneusz P. | |
dc.date.accessioned | 2024-06-27T08:10:33Z | |
dc.date.available | 2024-06-27T08:10:33Z | |
dc.date.created | 2024-06-13T15:40:28Z | |
dc.date.issued | 2024 | |
dc.identifier.citation | International Journal of Molecular Sciences. 2024, 25, 6533. | en_US |
dc.identifier.issn | 1661-6596 | |
dc.identifier.uri | https://hdl.handle.net/11250/3136118 | |
dc.description.abstract | Extracellular vesicles (EVs) hold great promise for clinical application as new diagnostic and therapeutic modalities. This paper describes major GMP-based upstream and downstream manufacturing processes for EV large-scale production, also focusing on post-processing technologies such as surface bioengineering and uploading studies to yield novel EV-based diagnostics and advanced therapy medicinal products. This paper also focuses on the quality, safety, and efficacy issues of the bioengineered EV drug candidates before first-in-human studies. Because clinical trials involving extracellular vesicles are on the global rise, this paper encompasses different clinical studies registered on clinical-trial register platforms, with varying levels of advancement, highlighting the growing interest in EV-related clinical programs. Navigating the regulatory affairs of EVs poses real challenges, and obtaining marketing authorization for EV-based medicines remains complex due to the lack of specific regulatory guidelines for such novel products. This paper discusses the state-of-the-art regulatory knowledge to date on EV-based diagnostics and medicinal products, highlighting further research and global regulatory needs for the safe and reliable implementation of bioengineered EVs as diagnostic and therapeutic tools in clinical settings. Post-marketing pharmacovigilance for EV-based medicinal products is also presented, mainly addressing such topics as risk assessment and risk management. | en_US |
dc.language.iso | eng | en_US |
dc.rights | Navngivelse 4.0 Internasjonal | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/deed.no | * |
dc.title | Extracellular Vesicles as Next-Generation Diagnostics and Advanced Therapy Medicinal Products | en_US |
dc.title.alternative | Extracellular Vesicles as Next-Generation Diagnostics and Advanced Therapy Medicinal Products | en_US |
dc.type | Peer reviewed | en_US |
dc.type | Journal article | en_US |
dc.description.version | publishedVersion | en_US |
dc.rights.holder | © 2024 by the authors. Licensee MDPI, Basel, Switzerland. | en_US |
dc.source.pagenumber | 29 | en_US |
dc.source.volume | 25 | en_US |
dc.source.journal | International Journal of Molecular Sciences | en_US |
dc.identifier.doi | 10.3390/ijms25126533 | |
dc.identifier.cristin | 2276048 | |
dc.relation.project | Norges forskningsråd: NOR/POLNOR/TEPCAN/0057/2019-00 | en_US |
dc.source.articlenumber | 6533 | en_US |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 1 | |