Validation of Bioreactor and Human-on-a-Chip Devices for Chemical Safety Assessment.
Equipment and device qualification and test assay validation in the field of tissue engineered human organs for substance assessment remain formidable tasks with only a few successful examples so far. The hurdles seem to increase with the growing complexity of the biological systems, emulated by the respective models. Controlled single tissue or organ culture in bioreactors improves the organ-specific functions and maintains their phenotypic stability for longer periods of time. The reproducibility attained with bioreactor operations is, per se, an advantage for the validation of safety assessment. Regulatory agencies have gradually altered the validation concept from exhaustive "product" to rigorous and detailed process characterization, valuing reproducibility as a standard for validation. "Human-on-a-chip" technologies applying micro-physiological systems to the in vitro combination of miniaturized human organ equivalents into functional human micro-organisms are nowadays thought to be the most elaborate solution created to date. They target the replacement of the current most complex models-laboratory animals. Therefore, we provide here a road map towards the validation of such "human-on-a-chip" models and qualification of their respective bioreactor and microchip equipment along a path currently used for the respective animal models.
iBET, Instituto de Biologia Experimental e Tecnológica, Oeiras, 2780-901, Portugal.|Instituto de Tecnologia Química e Biológica, Universidade Nova de Lisboa, Oeiras, 2780-157, Portugal.
Sofia P
SP
Rebelo
Department of Medical Biotechnology, Technische Universität Berlin, Institute of Biotechnology, Gustav-Meyer-Allee 25, Berlin, 13355, Germany. eva.dehne@tissuse.com.
Eva-Maria
EM
Dehne
iBET, Instituto de Biologia Experimental e Tecnológica, Oeiras, 2780-901, Portugal.|Instituto de Tecnologia Química e Biológica, Universidade Nova de Lisboa, Oeiras, 2780-157, Portugal.
Catarina
C
Brito
Department of Medical Biotechnology, Technische Universität Berlin, Institute of Biotechnology, Gustav-Meyer-Allee 25, Berlin, 13355, Germany.
Reyk
R
Horland
iBET, Instituto de Biologia Experimental e Tecnológica, Oeiras, 2780-901, Portugal. marques@itqb.unl.pt.|Instituto de Tecnologia Química e Biológica, Universidade Nova de Lisboa, Oeiras, 2780-157, Portugal. marques@itqb.unl.pt.
Paula M
PM
Alves
Department of Medical Biotechnology, Technische Universität Berlin, Institute of Biotechnology, Gustav-Meyer-Allee 25, Berlin, 13355, Germany.
Uwe
U
Marx
D019149:Bioreactors; D062067:Chemical Safety; D006801:Humans; D056656:Lab-On-A-Chip Devices; D054928:Validation Studies as Topic
Bioreactor; Hollow fibre bioreactor; Human-on-a-chip (validation); Microbioreactor; Stirred-tank bioreactors