dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | López Navas, Luis |
dc.contributor.author | Sílvia Torrents |
dc.contributor.author | Sanchez-Pernaute, Rosario |
dc.contributor.author | Vives Armengol, Joaquim |
dc.date.accessioned | 2022-09-15T07:04:41Z |
dc.date.available | 2022-09-15T07:04:41Z |
dc.date.issued | 2022-08 |
dc.identifier.citation | Lopez-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.issn | 2157-6580 |
dc.identifier.uri | https://hdl.handle.net/11351/8195 |
dc.description | Non-clinical safety; Product development; Quality compliance |
dc.description.abstract | The 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.iso | eng |
dc.publisher | Oxford University Press |
dc.relation.ispartofseries | Stem Cells Translational Medicine;11(8) |
dc.rights | Attribution-NonCommercial 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ |
dc.source | Scientia |
dc.subject | Teràpia cel·lular |
dc.subject | Farmàcia - Investigació |
dc.subject | Control de qualitat - Normes |
dc.subject.mesh | Therapies, Investigational |
dc.subject.mesh | Quality Control |
dc.subject.mesh | Cell- and Tissue-Based Therapy |
dc.title | Compliance in Non-Clinical Development of Cell-, Gene-, and Tissue-Based Medicines: Good Practice for Better Therapies |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1093/stcltm/szac046 |
dc.subject.decs | tratamientos en investigación |
dc.subject.decs | control de calidad |
dc.subject.decs | tratamientos basados en células y tejidos |
dc.relation.publishversion | https://doi.org/10.1093/stcltm/szac046 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut 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.pmid | 35830540 |
dc.identifier.wos | 000826160100001 |
dc.relation.projectid | info:eu-repo/grantAgreement/ES/PE2017-2020/RD21%2F0017%2F0022 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |