Using Human Tissues, GMO and Stem Cells

Tissue samples of human origin are utilised by Orion in various in vitro studies in the drug discovery and development work. The human material is sourced from high standard, reliable and ethically solid suppliers which use controlled and traceable sources and provide documentation for the material. 

Human material enables prediction of metabolism routes, for example, or drug-drug interactions without exposure of human subjects to new chemical substances. Human material is also a basis for the selection of relevant animal species for toxicologic evaluation thus reducing animal studies. With these studies some of the clinical studies may even be replaced. Studies based on tissues obtained from humans and animal species are well established and are very widely used within the scientific community. Therefore, the pros and cons are well understood, thus increasing the prediction value of these systems.

Genetically modified organisms (GMO), genetically engineered whole cell systems or transgenic animals, are increasingly used for research purposes in the pharmaceutical industry. Such models are used in strictly controlled laboratory environment for efficacy and safety evaluations of drug molecules as well as for mechanistic studies to understand human disease, thereby increasing the prediction value of nonclinical research. Predictive cell models are key methods in reducing laboratory animal use. Gene technologies also represent sustainable chemistry. We believe that integration of bio-processes with conventional chemistry is a key towards sustainable production of complex molecules.

Stem cell technologies are an emerging part in the toolbox for nonclinical studies. Earlier these approaches have been based on human embryonic stem cells. However, the recent development towards human induced pluripotent stem (iPS) cells have shown potential to be a future source of stem cells for research purposes avoiding the ethical issues associated with the use of the stem cells of embryonic origin.

The techniques described above are mechanistic models mainly helping to understand complex biological processes and disease as well as to study the effects of drug molecules in relevant human models. Orion’s highly educated experts keep on following the latest developments in these fields. Understanding the mechanisms of diseases and the behavior of new chemical entities in biological systems, the most effective and safe candidates can be selected to be forwarded to clinical trials without unnecessary exposure of laboratory animals and, eventually, human subjects to the compound.

 

The next pages of the Policy:

Ethics in Clinical Research Phases >>

Ethics in the Marketing Phase >>