About this Research Topic
There is an increasing acceptance of the role in vitro assays can play in assuring the safety and health of the population, particularly as part of Next Generation Risk Assessment (NGRA). NGRA is an exposure-led, hypothesis-driven approach integrating New Approach Methodologies (NAMs) to ensure chemical safety without the use of animal testing. In addition to any ethical considerations, there is also a growing desire to remove animal products from these in vitro assays to make them more scientifically robust and human-relevant . For example, the use of foetal bovine serum (FBS) and animal-derived antibodies can introduce batch-to-batch variability potentially resulting in experimental quality (e.g. contamination of FBS; specificity of antibodies) and reproducibility issues.
In 2008, the ECVAM Scientific Advisory Committee (ESAC) advocated for the use of non-animal derived supplements for in vitro studies wherever possible and stated that “for methods forwarded to ECVAM for validation/pre-validation where [the use of non-animal alternatives to serum] is not fulfilled a justification for future use must be provided, including measures taken to seek non-animal alternatives to [FBS]”. The recent EURL ECVAM paper on animal derived antibodies (Viegas Barosso et al, 2020) also sets out a clear position: "EURL ECVAM recommends that animals should no longer be used for the development and production of antibodies for research, regulatory, diagnostic and therapeutic applications. In the EU, the provisions of Directive 2010/63/EU should be respected, and EU countries should no longer authorise the development and production of antibodies through animal immunisation, where robust, legitimate scientific justification is lacking.” This collection will look at how these recommendations can and have been practically applied. At present each approach is very bespoke. Therefore, for wide-spread uptake there is a need for a concerted, collaborative effort.
Additionally, it is more frequently becoming recognised that knowledge of all the constituents of the cell culture medium used and their influence on cellular processes are important for improved reproducibility . Therefore, ideally chemically-defined media would be used to culture human cells for in vitro assays to eliminate any remaining scientific quality issues resulting from use of animal- or human-derived components , especially as there are also potential ethical issues regarding the supply of human-derived products which also need to be taken into consideration.
In summary, the aim of this collection would be to describe the benefits, challenges and current options for replacing animal-derived products in in vitro systems for use in regulatory safety testing, and to initiate a discussion on the impact these changes might have in this context.
We particularly welcome and encourage Original Research, Reviews and Perspectives articles to this topic.
Topic Editor Andrew Scott is an employee of Unilever and holds shares in Unilever plc which is co-funding (with the NC3Rs) a collaborative research project aiming to test the feasibility of adapting two OECD guideline assays to animal-free in vitro conditions. The other Topic Editors declare no competing interests with regard to the Research Topic subject.
In 2008, the ECVAM Scientific Advisory Committee (ESAC) advocated for the use of non-animal derived supplements for in vitro studies wherever possible and stated that “for methods forwarded to ECVAM for validation/pre-validation where [the use of non-animal alternatives to serum] is not fulfilled a justification for future use must be provided, including measures taken to seek non-animal alternatives to [FBS]”. The recent EURL ECVAM paper on animal derived antibodies (Viegas Barosso et al, 2020) also sets out a clear position: "EURL ECVAM recommends that animals should no longer be used for the development and production of antibodies for research, regulatory, diagnostic and therapeutic applications. In the EU, the provisions of Directive 2010/63/EU should be respected, and EU countries should no longer authorise the development and production of antibodies through animal immunisation, where robust, legitimate scientific justification is lacking.” This collection will look at how these recommendations can and have been practically applied. At present each approach is very bespoke. Therefore, for wide-spread uptake there is a need for a concerted, collaborative effort.
Additionally, it is more frequently becoming recognised that knowledge of all the constituents of the cell culture medium used and their influence on cellular processes are important for improved reproducibility . Therefore, ideally chemically-defined media would be used to culture human cells for in vitro assays to eliminate any remaining scientific quality issues resulting from use of animal- or human-derived components , especially as there are also potential ethical issues regarding the supply of human-derived products which also need to be taken into consideration.
In summary, the aim of this collection would be to describe the benefits, challenges and current options for replacing animal-derived products in in vitro systems for use in regulatory safety testing, and to initiate a discussion on the impact these changes might have in this context.
We particularly welcome and encourage Original Research, Reviews and Perspectives articles to this topic.
Topic Editor Andrew Scott is an employee of Unilever and holds shares in Unilever plc which is co-funding (with the NC3Rs) a collaborative research project aiming to test the feasibility of adapting two OECD guideline assays to animal-free in vitro conditions. The other Topic Editors declare no competing interests with regard to the Research Topic subject.
Keywords: Regulatory Toxicology, In vitro, Animal free, NAMs
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