Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology

Monica Piergiovanni; Milena Mennecozzi; Erio Barale-Thomas; Davide Danovi; Sebastian Dunst; David Egan; Aurora Fassi; Matthew Hartley; Philipp Kainz; Katharina Koch; Sylvia E. Le Dévédec; Iris Mangas; Elena Miranda; Jo Nyffeler; Enrico Pesenti; Fernanda Ricci; Christopher Schmied; Alexander Schreiner; Nadine Stokar-Regenscheit; Jason R. Swedlow; Virginie Uhlmann; Fredrik C. Wieland; Amy Wilson; Maurice Whelan

doi:10.1007/s00204-024-03922-z

Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology

Monica Piergiovanni (Lead / Corresponding author), Milena Mennecozzi, Erio Barale-Thomas, Davide Danovi, Sebastian Dunst, David Egan, Aurora Fassi, Matthew Hartley, Philipp Kainz, Katharina Koch, Sylvia E. Le Dévédec, Iris Mangas, Elena Miranda, Jo Nyffeler, Enrico Pesenti, Fernanda Ricci, Christopher Schmied, Alexander Schreiner, Nadine Stokar-Regenscheit, Jason R. SwedlowVirginie Uhlmann, Fredrik C. Wieland, Amy Wilson, Maurice Whelan

Molecular Cell and Developmental Biology

Research output: Contribution to journal › Review article › peer-review

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Abstract

Imaging technologies are being increasingly used in biomedical research and experimental toxicology to gather morphological and functional information from cellular models. There is a concrete opportunity of incorporating imaging-based in vitro methods in international guidelines to respond to regulatory requirements with human relevant data. To translate these methods from R&D to international regulatory acceptance, the community needs to implement test methods under quality management systems, assess inter-laboratory transferability, and demonstrate data reliability and robustness. This article summarises current challenges associated with image acquisition, image analysis, including artificial intelligence, and data management of imaging-based methods, with examples from the developmental neurotoxicity in vitro battery and phenotypic profiling assays. The article includes considerations on specific needs and potential solutions to design and implement future validation and transferability studies.

Original language	English
Pages (from-to)	1271-1285
Number of pages	15
Journal	Archives of Toxicology
Volume	99
Issue number	4
Early online date	13 Feb 2025
DOIs	https://doi.org/10.1007/s00204-024-03922-z
Publication status	Published - Apr 2025

Keywords

3Rs
Artificial intelligence
High content imaging
Imaging-based in vitro methods
Regulatory toxicology
Validation

ASJC Scopus subject areas

Toxicology
Health, Toxicology and Mutagenesis

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Piergiovanni, M., Mennecozzi, M., Barale-Thomas, E., Danovi, D., Dunst, S., Egan, D., Fassi, A., Hartley, M., Kainz, P., Koch, K., Le Dévédec, S. E., Mangas, I., Miranda, E., Nyffeler, J., Pesenti, E., Ricci, F., Schmied, C., Schreiner, A., Stokar-Regenscheit, N., ... Whelan, M. (2025). Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology. Archives of Toxicology, 99(4), 1271-1285. https://doi.org/10.1007/s00204-024-03922-z

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abstract = "Imaging technologies are being increasingly used in biomedical research and experimental toxicology to gather morphological and functional information from cellular models. There is a concrete opportunity of incorporating imaging-based in vitro methods in international guidelines to respond to regulatory requirements with human relevant data. To translate these methods from R\&D to international regulatory acceptance, the community needs to implement test methods under quality management systems, assess inter-laboratory transferability, and demonstrate data reliability and robustness. This article summarises current challenges associated with image acquisition, image analysis, including artificial intelligence, and data management of imaging-based methods, with examples from the developmental neurotoxicity in vitro battery and phenotypic profiling assays. The article includes considerations on specific needs and potential solutions to design and implement future validation and transferability studies.",

keywords = "3Rs, Artificial intelligence, High content imaging, Imaging-based in vitro methods, Regulatory toxicology, Validation",

author = "Monica Piergiovanni and Milena Mennecozzi and Erio Barale-Thomas and Davide Danovi and Sebastian Dunst and David Egan and Aurora Fassi and Matthew Hartley and Philipp Kainz and Katharina Koch and \{Le D{\'e}v{\'e}dec\}, \{Sylvia E.\} and Iris Mangas and Elena Miranda and Jo Nyffeler and Enrico Pesenti and Fernanda Ricci and Christopher Schmied and Alexander Schreiner and Nadine Stokar-Regenscheit and Swedlow, \{Jason R.\} and Virginie Uhlmann and Wieland, \{Fredrik C.\} and Amy Wilson and Maurice Whelan",

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year = "2025",

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doi = "10.1007/s00204-024-03922-z",

language = "English",

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Piergiovanni, M, Mennecozzi, M, Barale-Thomas, E, Danovi, D, Dunst, S, Egan, D, Fassi, A, Hartley, M, Kainz, P, Koch, K, Le Dévédec, SE, Mangas, I, Miranda, E, Nyffeler, J, Pesenti, E, Ricci, F, Schmied, C, Schreiner, A, Stokar-Regenscheit, N, Swedlow, JR, Uhlmann, V, Wieland, FC, Wilson, A & Whelan, M 2025, 'Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology', Archives of Toxicology, vol. 99, no. 4, pp. 1271-1285. https://doi.org/10.1007/s00204-024-03922-z

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T1 - Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology

AU - Piergiovanni, Monica

AU - Mennecozzi, Milena

AU - Barale-Thomas, Erio

AU - Danovi, Davide

AU - Dunst, Sebastian

AU - Egan, David

AU - Fassi, Aurora

AU - Hartley, Matthew

AU - Kainz, Philipp

AU - Koch, Katharina

AU - Le Dévédec, Sylvia E.

AU - Mangas, Iris

AU - Miranda, Elena

AU - Nyffeler, Jo

AU - Pesenti, Enrico

AU - Ricci, Fernanda

AU - Schmied, Christopher

AU - Schreiner, Alexander

AU - Stokar-Regenscheit, Nadine

AU - Swedlow, Jason R.

AU - Uhlmann, Virginie

AU - Wieland, Fredrik C.

AU - Wilson, Amy

AU - Whelan, Maurice

PY - 2025/4

Y1 - 2025/4

N2 - Imaging technologies are being increasingly used in biomedical research and experimental toxicology to gather morphological and functional information from cellular models. There is a concrete opportunity of incorporating imaging-based in vitro methods in international guidelines to respond to regulatory requirements with human relevant data. To translate these methods from R&D to international regulatory acceptance, the community needs to implement test methods under quality management systems, assess inter-laboratory transferability, and demonstrate data reliability and robustness. This article summarises current challenges associated with image acquisition, image analysis, including artificial intelligence, and data management of imaging-based methods, with examples from the developmental neurotoxicity in vitro battery and phenotypic profiling assays. The article includes considerations on specific needs and potential solutions to design and implement future validation and transferability studies.

AB - Imaging technologies are being increasingly used in biomedical research and experimental toxicology to gather morphological and functional information from cellular models. There is a concrete opportunity of incorporating imaging-based in vitro methods in international guidelines to respond to regulatory requirements with human relevant data. To translate these methods from R&D to international regulatory acceptance, the community needs to implement test methods under quality management systems, assess inter-laboratory transferability, and demonstrate data reliability and robustness. This article summarises current challenges associated with image acquisition, image analysis, including artificial intelligence, and data management of imaging-based methods, with examples from the developmental neurotoxicity in vitro battery and phenotypic profiling assays. The article includes considerations on specific needs and potential solutions to design and implement future validation and transferability studies.

KW - 3Rs

KW - Artificial intelligence

KW - High content imaging

KW - Imaging-based in vitro methods

KW - Regulatory toxicology

KW - Validation

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DO - 10.1007/s00204-024-03922-z

M3 - Review article

C2 - 39945818

AN - SCOPUS:85217821730

SN - 0340-5761

VL - 99

SP - 1271

EP - 1285

JO - Archives of Toxicology

JF - Archives of Toxicology

IS - 4

ER -

Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology

Abstract

Keywords

ASJC Scopus subject areas

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