Stem Cell-Derived Systems in Toxicology Assessment

The Good In Vitro Method Principles (GIVIMP) guidance will help to ensure that in vitro methods destined for regulatory use will prove to be robust, reliable and ultimately useful for supporting regulatory decisions. The paper on "Stem cell derived systems in toxicology assessment" gives a contribution to topic 4 of the envisaged GIVIMP guidance that will focus on the key importance of applying Good Cell Culture Practice, essential in the authentication and characterisation of the in vitro biological model (e.g. test systems such as cell lines, primary cells and tissues) used in in vitro methods. This book chapter contributes to the sufficient understanding of stem cells and of the relevant factors which could affect differentiation to wild type-like fully differentiated cells. Stem cell derived test-systems ultimately aim to provide physiological cell culture systems that are easily accessible and amenable to a variety of assays, including genetic manipulation. They also present the opportunity to maximise the utility of the vast repository of existing non-clinical data for a robust understanding of in vitro to in vivo translation. tem cell derived test-systems from target organs such as the liver, heart and kidney, as well as keratinocytes and neurons have been generated in several laboratories. However, characterisation of the in vitro biological stem cell models is an essential pre-requisite to use the for routine toxicological testing purposes.JRC.F.3-Chemicals Safety and Alternative Method