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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorLópez Navas, Luis
dc.contributor.authorSílvia Torrents
dc.contributor.authorSanchez-Pernaute, Rosario
dc.contributor.authorVives Armengol, Joaquim
dc.date.accessioned2022-09-15T07:04:41Z
dc.date.available2022-09-15T07:04:41Z
dc.date.issued2022-08
dc.identifier.citationLopez-Navas L, Torrents S, Sánchez-Pernaute R, Vives J. Compliance in Non-Clinical Development of Cell-, Gene-, and Tissue-Based Medicines: Good Practice for Better Therapies. Stem Cells Transl Med. 2022 Aug;11(8):805–13.
dc.identifier.issn2157-6580
dc.identifier.urihttp://hdl.handle.net/11351/8195
dc.descriptionNon-clinical safety; Product development; Quality compliance
dc.description.abstractThe development of cell-, gene- and tissue engineering (CGT)-based therapies must adhere to strict pharmaceutical quality management standards, as for any other biological or small-molecule drug. However, early developments often failed to fully comply with good laboratory practices (GLP) in non-clinical safety studies. Despite an upward trend of positive opinions in marketing authorization applications, evidence of adherence to the principles of GLP is not openly reported; therefore, their relative impact on the overall quality of the product development program is unknown. Herein we investigated the actual degree of GLP implementation and the underlying factors impeding full compliance in non-clinical developments of CGT-based marketed medicines in the EU and USA, including (i) the co-existence of diverse quality management systems of more strategic value for small organizations, particularly current Good Manufacturing Practices n(GMP); (ii) lack of regulatory pressure to pursue GLP certification; and (iii) the involvement of public institutions lacking a pharmaceutical mindset and resources. As a final reflection, we propose conformity to good research practice criteria not as a doctrinaire impediment to scientific work, but as a facilitator of efficient clinical translation of more effective and safer innovative therapies.
dc.language.isoeng
dc.publisherOxford University Press
dc.relation.ispartofseriesStem Cells Translational Medicine;11(8)
dc.rightsAttribution-NonCommercial 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.sourceScientia
dc.subjectTeràpia cel·lular
dc.subjectFarmàcia - Investigació
dc.subjectControl de qualitat - Normes
dc.subject.meshTherapies, Investigational
dc.subject.meshQuality Control
dc.subject.meshCell- and Tissue-Based Therapy
dc.titleCompliance in Non-Clinical Development of Cell-, Gene-, and Tissue-Based Medicines: Good Practice for Better Therapies
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1093/stcltm/szac046
dc.subject.decstratamientos en investigación
dc.subject.decscontrol de calidad
dc.subject.decstratamientos basados en células y tejidos
dc.relation.publishversionhttps://doi.org/10.1093/stcltm/szac046
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Lopez-Navas L, Sánchez-Pernaute R] Andalusian Network for the Design and Translation of Advanced Therapies, Andalusian Health Ministry, Sevilla, Spain. [Torrents S] Banc de Sang i Teixits, Barcelona, Spain. [Vives J] Banc de Sang i Teixits, Barcelona, Spain. Grup de Recerca en Enginyeria Tissular Musculoesquelètica, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain
dc.identifier.pmid35830540
dc.identifier.wos000826160100001
dc.relation.projectidinfo:eu-repo/grantAgreement/ES/PE2017-2020/RD21%2F0017%2F0022
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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