Compliance in Non-Clinical Development of Cell-, Gene-, and Tissue-Based Medicines : Good Practice for Better Therapies
Lopez-Navas, Luís (Andalusian Network for the Design and Translation of Advanced Therapies. Andalusian Health Ministry)
Torrents, Sílvia (Banc de Sang i Teixits. Edifici Dr. Frederic Duran i Jordà)
Sánchez-Pernaute, Rosario (Andalusian Network for the Design and Translation of Advanced Therapies. Andalusian Health Ministry)
Vives, Joaquin (Universitat Autònoma de Barcelona. Departament de Medicina)

Data:	2022
Resum:	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.
Ajuts:	Instituto de Salud Carlos III RD21/0017/0015 Instituto de Salud Carlos III RD21/0017/0022
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	Stem Cells Translational Medicine, Vol. 11 Núm. 8 (august 2022) , p. 805-813, ISSN 2157-6580

DOI: 10.1093/stcltm/szac046
PMID: 35830540

10 p, 3.5 MB

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