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dc.contributor.authorVervaeke, P.
dc.contributor.authorBorgos, Sven Even F.
dc.contributor.authorSanders, N.N.
dc.contributor.authorCombes, Francis
dc.date.accessioned2022-08-08T09:05:28Z
dc.date.available2022-08-08T09:05:28Z
dc.date.created2022-05-24T09:42:48Z
dc.date.issued2022
dc.identifier.citationAdvanced Drug Delivery Reviews. 2022, 184 1-17.en_US
dc.identifier.issn0169-409X
dc.identifier.urihttps://hdl.handle.net/11250/3010571
dc.description.abstractThe success of the messenger RNA-based COVID-19 vaccines of Moderna and Pfizer/BioNTech marks the beginning of a new chapter in modern medicine. However, the rapid rise of mRNA therapeutics has resulted in a regulatory framework that is somewhat lagging. The current guidelines either do not apply, do not mention RNA therapeutics, or do not have widely accepted definitions. This review describes the guidelines for preclinical biodistribution studies of mRNA/siRNA therapeutics and highlights the relevant differences for mRNA vaccines. We also discuss the role of in vivo RNA imaging techniques and other assays to fulfill and/or complement the regulatory requirements. Specifically, quantitative whole-body autoradiography, microautoradiography, mass spectrometry-based assays, hybridization techniques (FISH, bDNA), PCR-based methods, in vivo fluorescence imaging, and in vivo bioluminescence imaging, are discussed. We conclude that this new and rapidly evolving class of medicines demands a multi-layered approach to fully understand its biodistribution and in vivo characteristics.en_US
dc.language.isoengen_US
dc.publisherElsevieren_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/deed.no*
dc.subjectModernaen_US
dc.subjectSpikevaxen_US
dc.subjectPfizer/BioNTechen_US
dc.subjectComirnatmyen_US
dc.subjectLumasiranen_US
dc.subjectOxlumoen_US
dc.subjectInclisiranen_US
dc.subjectLeqvioen_US
dc.subjectGivosiranen_US
dc.subjectGivlaarien_US
dc.subjectPatisiranen_US
dc.subjectOnpattroen_US
dc.subjectRegulatoryen_US
dc.subjectMass spectrometryen_US
dc.subjectbDNAen_US
dc.subjectFISHen_US
dc.subjectRT-qPCRen_US
dc.subjectQWBAen_US
dc.subjectBLIen_US
dc.subjectFLIen_US
dc.subjectImagingen_US
dc.subjectLNPen_US
dc.subjectLipid nanoparticleen_US
dc.subjectVaccineen_US
dc.subjectmRNAen_US
dc.subjectsiRNAen_US
dc.subjectRNA therapeuticen_US
dc.subjectDistributionen_US
dc.subjectBiodistributionen_US
dc.subjectGuidelinesen_US
dc.titleRegulatory guidelines and preclinical tools to study the biodistribution of RNA therapeuticsen_US
dc.title.alternativeRegulatory guidelines and preclinical tools to study the biodistribution of RNA therapeuticsen_US
dc.typePeer revieweden_US
dc.typeJournal articleen_US
dc.description.versionpublishedVersionen_US
dc.rights.holderCopyright: 2022 The Authors. Published by Elsevier B.Ven_US
dc.source.pagenumber1-17en_US
dc.source.volume184en_US
dc.source.journalAdvanced Drug Delivery Reviewsen_US
dc.identifier.doi10.1016/j.addr.2022.114236
dc.identifier.cristin2026803
dc.source.articlenumber114236en_US
cristin.ispublishedtrue
cristin.fulltextoriginal
cristin.qualitycode1


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