Caco-2 Cell Line Standardization with Pharmaceutical Requirements and In Vitro Model Suitability for Permeability Assays

The Caco-2 cell line derived from human colon carcinoma is commonly used to assess the permeability of compounds in in vitro conditions. Due to the significant increase in permeability studies using the Caco-2 cell line in recent years, the need to standardize this biological model seems necessary....

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Main Authors: Marta Kus, Izabela Ibragimow, Hanna Piotrowska-Kempisty
Format: Article
Language:English
Published: MDPI AG 2023-10-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/15/11/2523
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author Marta Kus
Izabela Ibragimow
Hanna Piotrowska-Kempisty
author_facet Marta Kus
Izabela Ibragimow
Hanna Piotrowska-Kempisty
author_sort Marta Kus
collection DOAJ
description The Caco-2 cell line derived from human colon carcinoma is commonly used to assess the permeability of compounds in in vitro conditions. Due to the significant increase in permeability studies using the Caco-2 cell line in recent years, the need to standardize this biological model seems necessary. The pharmaceutical requirements define only the acceptance criteria for the validation of the Caco-2 cell line and do not specify the protocol for its implementation. Therefore, the aim of this study is to review the conditions for permeability studies across the Caco-2 monolayer reported in the available literature concerning validation guidelines. We summarized the main aspects affecting the validation process of the Caco-2 cell line, including the culture conditions, cytotoxicity, cell differentiation process, and monolayer transport conditions, and the main conclusions may be useful in developing individual methods for preparing the cell line for validation purposes and further permeability research.
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spelling doaj.art-19cc1185abf14af9ae3ed530048d6a4f2023-11-24T15:00:42ZengMDPI AGPharmaceutics1999-49232023-10-011511252310.3390/pharmaceutics15112523Caco-2 Cell Line Standardization with Pharmaceutical Requirements and In Vitro Model Suitability for Permeability AssaysMarta Kus0Izabela Ibragimow1Hanna Piotrowska-Kempisty2Department of Toxicology, Poznan University of Medical Sciences, 30 Dojazd St., 60-631 Poznan, PolandResearch and Development Department of Ethifarm, Ethifarm Manufacturing Plant, 9 Stefana Zeromskiego St., 60-544 Poznan, PolandDepartment of Toxicology, Poznan University of Medical Sciences, 30 Dojazd St., 60-631 Poznan, PolandThe Caco-2 cell line derived from human colon carcinoma is commonly used to assess the permeability of compounds in in vitro conditions. Due to the significant increase in permeability studies using the Caco-2 cell line in recent years, the need to standardize this biological model seems necessary. The pharmaceutical requirements define only the acceptance criteria for the validation of the Caco-2 cell line and do not specify the protocol for its implementation. Therefore, the aim of this study is to review the conditions for permeability studies across the Caco-2 monolayer reported in the available literature concerning validation guidelines. We summarized the main aspects affecting the validation process of the Caco-2 cell line, including the culture conditions, cytotoxicity, cell differentiation process, and monolayer transport conditions, and the main conclusions may be useful in developing individual methods for preparing the cell line for validation purposes and further permeability research.https://www.mdpi.com/1999-4923/15/11/2523Caco-2 cell linevalidationdrug permeabilitypharmaceutical requirementsbiowaiver
spellingShingle Marta Kus
Izabela Ibragimow
Hanna Piotrowska-Kempisty
Caco-2 Cell Line Standardization with Pharmaceutical Requirements and In Vitro Model Suitability for Permeability Assays
Pharmaceutics
Caco-2 cell line
validation
drug permeability
pharmaceutical requirements
biowaiver
title Caco-2 Cell Line Standardization with Pharmaceutical Requirements and In Vitro Model Suitability for Permeability Assays
title_full Caco-2 Cell Line Standardization with Pharmaceutical Requirements and In Vitro Model Suitability for Permeability Assays
title_fullStr Caco-2 Cell Line Standardization with Pharmaceutical Requirements and In Vitro Model Suitability for Permeability Assays
title_full_unstemmed Caco-2 Cell Line Standardization with Pharmaceutical Requirements and In Vitro Model Suitability for Permeability Assays
title_short Caco-2 Cell Line Standardization with Pharmaceutical Requirements and In Vitro Model Suitability for Permeability Assays
title_sort caco 2 cell line standardization with pharmaceutical requirements and in vitro model suitability for permeability assays
topic Caco-2 cell line
validation
drug permeability
pharmaceutical requirements
biowaiver
url https://www.mdpi.com/1999-4923/15/11/2523
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AT hannapiotrowskakempisty caco2celllinestandardizationwithpharmaceuticalrequirementsandinvitromodelsuitabilityforpermeabilityassays