Analysis of reproducibility and robustness of OrganoPlate® 2-lane 96, a liver microphysiological system for studies of pharmacokinetics and toxicological assessment of drugs
Tài liệu tham khảo
Ang, 2018, A roadmap for human liver differentiation from pluripotent stem cells, Cell Rep., 22, 2190, 10.1016/j.celrep.2018.01.087
Baudy, 2020, Liver microphysiological systems development guidelines for safety risk assessment in the pharmaceutical industry, Lab Chip, 20, 215, 10.1039/C9LC00768G
Beggs, 2014, Molecular mechanisms of hepatocellular apoptosis induced by trovafloxacin-tumor necrosis factor-alpha interaction, Toxicol. Sci., 137, 91, 10.1093/toxsci/kft226
Bell, 2018, Comparison of hepatic 2D Sandwich cultures and 3D spheroids for Long-term toxicity applications: a multicenter study, Toxicol. Sci., 162, 655, 10.1093/toxsci/kfx289
Bircsak, 2021, A 3D microfluidic liver model for high throughput compound toxicity screening in the OrganoPlate(R), Toxicology, 450, 10.1016/j.tox.2020.152667
Bulutoglu, 2020, A comparison of hepato-cellular in vitro platforms to study CYP3A4 induction, PLoS One, 15, 10.1371/journal.pone.0229106
Burnett, 2019, Population-based toxicity screening in human induced pluripotent stem cell-derived cardiomyocytes, Toxicol. Appl. Pharmacol., 381, 10.1016/j.taap.2019.114711
Collins, 2019, In vitro models of the liver: disease modeling, drug discovery and clinical applications
Corbett, 2019, iPSC-derived hepatocytes as a platform for disease modeling and drug discovery, Front. Med., 6, 265, 10.3389/fmed.2019.00265
Dickmann, 2011, Effects of interleukin-6 (IL-6) and an anti-IL-6 monoclonal antibody on drug-metabolizing enzymes in human hepatocyte culture, Drug Metab. Dispos., 39, 1415, 10.1124/dmd.111.038679
Dorne, 2003, Human variability in CYP3A4 metabolism and CYP3A4-related uncertainty factors for risk assessment, Food Chem. Toxicol., 41, 201, 10.1016/S0278-6915(02)00209-0
Ewart, 2021, Opportunities and challenges with microphysiological systems: a pharma end-user perspective, Nat. Rev. Drug Discov., 20, 327, 10.1038/d41573-020-00030-2
Ewart, 2017, Navigating tissue chips from development to dissemination: a pharmaceutical industry perspective, Exp. Biol. Med., 242, 1579, 10.1177/1535370217715441
Godoy, 2013, Recent advances in 2D and 3D in vitro systems using primary hepatocytes, alternative hepatocyte sources and non-parenchymal liver cells and their use in investigating mechanisms of hepatotoxicity, cell signaling and ADME, Arch. Toxicol., 87, 1315, 10.1007/s00204-013-1078-5
Hewitt, 2007, Primary hepatocytes: current understanding of the regulation of metabolic enzymes and transporter proteins, and pharmaceutical practice for the use of hepatocytes in metabolism, enzyme induction, transporter, clearance, and hepatotoxicity studies, Drug Metab. Rev., 39, 159, 10.1080/03602530601093489
Jang, 2019, Reproducing human and cross-species drug toxicities using a liver-Chip, Sci. Transl. Med., 11, eaax5516, 10.1126/scitranslmed.aax5516
Kang, 2020, Development and application of a transcriptomic signature of bioactivation in an advanced in vitro liver model to reduce drug-induced liver injury risk early in the pharmaceutical pipeline, Toxicol. Sci., 177, 121, 10.1093/toxsci/kfaa094
Keemink, 2015, Primary hepatocytes in Sandwich culture, Methods Mol. Biol., 1250, 175, 10.1007/978-1-4939-2074-7_12
Kmiec, 2001, Cooperation of liver cells in health and disease, Adv. Anat. Embryol. Cell Biol., 161, 10.1007/978-3-642-56553-3_7
Kullak-Ublick, 2017, Drug-induced liver injury: recent advances in diagnosis and risk assessment, Gut, 66, 1154, 10.1136/gutjnl-2016-313369
LeCluyse, 2012, Organotypic liver culture models: meeting current challenges in toxicity testing, Crit. Rev. Toxicol., 42, 501, 10.3109/10408444.2012.682115
Lee-Montiel, 2017, Control of oxygen tension recapitulates zone-specific functions in human liver microphysiology systems, Exp. Biol. Med., 242, 1617, 10.1177/1535370217703978
Livingston, 2016, Facilitating the commercialization and use of organ platforms generated by the microphysiological systems (tissue chip) program through public-private partnerships, Comput. Struct. Biotechnol. J., 14, 207, 10.1016/j.csbj.2016.04.003
Low, 2021, Organs-on-chips: into the next decade, Nat. Rev. Drug Discov., 20, 345, 10.1038/s41573-020-0079-3
Lu, 2015, Morphological and functional characterization and assessment of iPSC-derived hepatocytes for in vitro toxicity testing, Toxicol. Sci., 147, 39, 10.1093/toxsci/kfv117
Machin, 2011
Monticello, 2017, Current nonclinical testing paradigm enables safe entry to first-in-human clinical trials: the IQ consortium nonclinical to clinical translational database, Toxicol. Appl. Pharmacol., 334, 100, 10.1016/j.taap.2017.09.006
Ramaiahgari, 2017, Three-dimensional (3D) HepaRG spheroid model with physiologically relevant xenobiotic metabolism competence and hepatocyte functionality for liver toxicity screening, Toxicol. Sci., 159, 124, 10.1093/toxsci/kfx122
Roberts, 2007, Role of the Kupffer cell in mediating hepatic toxicity and carcinogenesis, Toxicol. Sci., 96, 2, 10.1093/toxsci/kfl173
Rubiano, 2021, Characterizing the reproducibility in using a liver microphysiological system for assaying drug toxicity, metabolism, and accumulation, Clin. Transl. Sci., 14, 1049, 10.1111/cts.12969
Rusyn, 2021, Key characteristics of human hepatotoxicants as a basis for identification and characterization of the causes of liver toxicity, Hepatology, 74, 3486, 10.1002/hep.31999
Rusyn, 2022, Microphysiological systems evaluation: experience of TEX-VAL tissue chip testing consortium, Toxicol. Sci., 188, 143, 10.1093/toxsci/kfac061
Sakolish, 2021, Prediction of hepatic drug clearance with a human microfluidic four-cell liver acinus microphysiology system, Toxicology, 463, 10.1016/j.tox.2021.152954
Sakolish, 2021, Analysis of reproducibility and robustness of a human microfluidic four-cell liver acinus microphysiology system (LAMPS), Toxicology, 448, 10.1016/j.tox.2020.152651
Sasserath, 2020, Differential monocyte actuation in a three-organ functional innate immune system-on-a-chip, Adv. Sci., 7, 2000323, 10.1002/advs.202000323
Shaw, 2007, Lipopolysaccharide and trovafloxacin coexposure in mice causes idiosyncrasy-like liver injury dependent on tumor necrosis factor-alpha, Toxicol. Sci., 100, 259, 10.1093/toxsci/kfm218
Sirenko, 2014, High-content assays for hepatotoxicity using induced pluripotent stem cell-derived cells, Assay Drug Dev. Technol., 12, 43, 10.1089/adt.2013.520
Sistare, 2016, The promise of new technologies to reduce, refine, or replace animal use while reducing risks of drug induced liver injury in pharmaceutical development, ILAR J., 57, 186, 10.1093/ilar/ilw025
Smith, 2003, Mechanisms of troglitazone hepatotoxicity, Chem. Res. Toxicol., 16, 679, 10.1021/tx034033e
Soldatow, 2013, In vitro models for liver toxicity testing, Toxicol. Res., 2, 23, 10.1039/C2TX20051A
Taylor, 2019, Harnessing human microphysiology systems as key experimental models for quantitative systems pharmacology, Handb. Exp. Pharmacol., 260, 327, 10.1007/164_2019_239
Tsamandouras, 2017, Quantitative assessment of population variability in hepatic drug metabolism using a perfused three-dimensional human liver microphysiological system, J. Pharmacol. Exp. Ther., 360, 95, 10.1124/jpet.116.237495
Ulrich, 2007, Idiosyncratic toxicity: a convergence of risk factors, Annu. Rev. Med., 58, 17, 10.1146/annurev.med.58.072905.160823
Underhill, 2018, Bioengineered liver models for drug testing and cell differentiation studies, Cell. Mol. Gastroenterol. Hepatol., 5, 10.1016/j.jcmgh.2017.11.012
Utkarsh, 2016, In vitro evaluation of hepatotoxic drugs in human hepatocytes from multiple donors: identification of P450 activity as a potential risk factor for drug-induced liver injuries, Chem. Biol. Interact., 255, 12, 10.1016/j.cbi.2015.12.013
Vernetti, 2016, A human liver microphysiology platform for investigating physiology, drug safety, and disease models, Exp. Biol. Med., 241, 101, 10.1177/1535370215592121
Vulto, 2011, Phaseguides: a paradigm shift in microfluidic priming and emptying, Lab Chip, 11, 1596, 10.1039/c0lc00643b
Ware, 2017, Exploring chronic drug effects on microengineered human liver cultures using global gene expression profiling, Toxicol. Sci., 157, 387, 10.1093/toxsci/kfx059
Waring, 2006, Microarray analysis of lipopolysaccharide potentiation of trovafloxacin-induced liver injury in rats suggests a role for proinflammatory chemokines and neutrophils, J. Pharmacol. Exp. Ther., 316, 1080, 10.1124/jpet.105.096347
Yamaguchi, 2019, Generation of functional human hepatocytes in vitro: current status and future prospects, Inflamm. Regen., 39, 13, 10.1186/s41232-019-0102-4
Yokoyama, 2018, Comparison of drug metabolism and its related hepatotoxic effects in HepaRG, cryopreserved human hepatocytes, and HepG2 cell cultures, Biol. Pharm. Bull., 41, 722, 10.1248/bpb.b17-00913
Zar, 1984