Compliance in Non-Clinical Development of Cell-, Gene-, and Tissue-Based Medicines: Good Practice for Better Therapies
Por:
Lopez-Navas, L, Torrents, S, Sanchez-Pernaute, R, Vives, J
Publicada:
23 ago 2022
Ahead of Print:
1 jul 2022
Resumen:
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.
Filiaciones:
Lopez-Navas, L:
Andalusian Hlth Minist, Andalusian Network Design & Translat Adv Therapie, Americo Vespucio 15 S-2, Seville 41092, Spain
Torrents, S:
Banc Sang & Teixits, Edifici Dr Frederic Duran & Jorda, Barcelona 08005, Spain
Sanchez-Pernaute, R:
Andalusian Hlth Minist, Andalusian Network Design & Translat Adv Therapie, Americo Vespucio 15 S-2, Seville 41092, Spain
Vives, J:
Banc Sang & Teixits, Edifici Dr Frederic Duran & Jorda, Barcelona 08005, Spain
Univ Autonoma Barcelona, Vall dHebron Res Inst VHIR, Musculoskeletal Tissue Engn Grp, Barcelona, Spain
Univ Autonoma Barcelona, Dept Med, Barcelona, Spain
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