{"id":116643,"date":"2026-09-11T15:11:43","date_gmt":"2026-09-11T13:11:43","guid":{"rendered":"https:\/\/nilu.gnist.dev\/publikasjoner\/extracellular-vesicles-as-next-generation-diagnostics-and-advanced-therapy-medicinal-products\/"},"modified":"2026-09-11T15:11:43","modified_gmt":"2026-09-11T13:11:43","slug":"extracellular-vesicles-as-next-generation-diagnostics-and-advanced-therapy-medicinal-products","status":"publish","type":"nva_publication","link":"https:\/\/nilu.gnist.dev\/en\/publications\/extracellular-vesicles-as-next-generation-diagnostics-and-advanced-therapy-medicinal-products\/","title":{"rendered":"Extracellular Vesicles as Next-Generation Diagnostics and \r\nAdvanced Therapy Medicinal Products"},"content":{"rendered":"<p class=\"wp-block-paragraph\">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.<\/p>\n","protected":false},"template":"","meta":{"_acf_changed":false,"_searchwp_excluded":"","_id":"","_status":"PUBLISHED","_sync_date":"2026-09-11 14:13:26","footnotes":""},"nva_tax_category":[1099],"class_list":["post-116643","nva_publication","type-nva_publication","status-publish","hentry","nva_tax_category-scientific-journal-publication"],"acf":[],"_links":{"self":[{"href":"https:\/\/nilu.gnist.dev\/en\/wp-json\/wp\/v2\/nva_publication\/116643","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nilu.gnist.dev\/en\/wp-json\/wp\/v2\/nva_publication"}],"about":[{"href":"https:\/\/nilu.gnist.dev\/en\/wp-json\/wp\/v2\/types\/nva_publication"}],"version-history":[{"count":0,"href":"https:\/\/nilu.gnist.dev\/en\/wp-json\/wp\/v2\/nva_publication\/116643\/revisions"}],"wp:attachment":[{"href":"https:\/\/nilu.gnist.dev\/en\/wp-json\/wp\/v2\/media?parent=116643"}],"wp:term":[{"taxonomy":"nva_tax_category","embeddable":true,"href":"https:\/\/nilu.gnist.dev\/en\/wp-json\/wp\/v2\/nva_tax_category?post=116643"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}