The Research Group for Life Sciences & Chemistry has obtained SIA RAAK-PRO funding for the development and implementation of two innovative intestinal in vitro models. These models, that are derived from fundamental research can play an important role in the safety and efficacy evaluation of food ingredients. The study aims to further develop, optimize and implement the culture models to increase the biological relevance and coincidentally increase applicability of the models, contributing to the adoption of the systems by industry. With the development and especially the implantation of these in vitro models the researchers hope to be able to contribute to the reduction of the use of animals in the safety evaluation of food additives and ingredients The project is designated with the acronym ‘2REAL-GUTS’ and is receiving approximately EUR 700,000 funding from the SIA RAAK-PRO programme. The aim is that the work will take 4 years to complete.
- This project is an example of how the increased understanding of human biology can contribute to the development of relevant and mechanism-based safety tests. Many safety tests used today were developed a long time ago, when our understanding of (human) biology was limited. These tests were often based on coincidental observations and their relevance and underlying mechanisms are mostly unknown. Focusing on the biological effects of pertussis toxin in the human body, human cell types involved in these in vivo effects were selected for study to ensure the biological relevance of the biomarkers that we discovered in this project.
- Assessing the safety and efficacy of natural products and their chemical content remains a challenge. This has resulted in European legislation to ensure scientific validation of health claims (The EFSA Journal 2008, 644, 1-44). In these validation processes, knowledge regarding the working mechanism of a product in relation to the safety and efficacy is of crucial importance. In addition, there is an urgent need to reduce and replace animal testing.
- Dopharma B.V. develops, produces and markets generic animal medicines. The medicines produced are mostly used for farm animals and therefore comprise mainly antibiotics and painkillers. In 2015, a 50% decrease in the usage of antibiotics must be achieved as compared to 2009, and in the new plans of the cabinet, this will even be increased to a 70% reduction. Obviously, Dopharma endorses a reasonable use of antibiotics, however, the reduction has a high impact on sales. For this reason, Dopharma decided to develop a new range of products, under the brand name Eviban. This is an acronym of ‘evidence-based nutrition’, and the company strategy demands that the new products have proven efficacy. Moreover, the new products should be based upon natural products, such as feed supplements or
- The SLIM project team focuses on developing and optimizing new test strategies for assessing the safety of a product that could accelerate product development and at the same time reduce the number of animal experiments. Currently we are working on four cases studies within different research areas; carcinogenicity, allergenicity, reproductive/developmental toxicity and barrier functions (pharmacokinetics). Two case studies focus on retrospective analysis of animal experiments and aiming to identify whether less animals could be used, without lowering the safety of new products. Another case study focuses on developing in vitro models to screen and identify compounds that could induce embryotoxicity or allergic reactions. The fourth uses different in vitro models to study intestinal absorption.
- This project has yielded several interesting end-products: We published the data of the first phase of the project in Teunis et al. 2013, and another manuscript has been submitted. The results of the project lead to another publication in the open source journal International Innovation in April 2013. Furthermore, the results have been submitted to ECVAM for review. They will consider whether formal validation is feasible on the basis of these and other results on the tested methods.