Today preclinical toxicological studies are performed on animals. Since drugs interact with proteins, and since proteins differ between species, a drug will not necessarily have the same effects in humans as in animals.

The consequence of this is that results of toxicological studies in animals can lead to wrongful termination of drug candidates potentially beneficial to humans and also to continued development of drug candidates later shown to be toxic to humans. Furthermore, even individual animals are genetically different and will thus, respond differently. This makes it difficult to standardize animal studies.

Our toxicological studies (e.g. for hits, leads and drug candidates) are performed on fully differentiated human hepatic ProtoTissue grown in our proprietary Bioreactor. Such ProtoTissue can be maintained fully differentiated for up to a year under in vivo-like conditions thereby mimicking the human liver function. The use of genetically identical hepatocytes as basis for our ProtoTissue provides long term high reproducibility without genetic drift.

Drug candidates added to the human hepatic ProtoTissue are metabolized; in this way the hepatic ProtoTissue is exposed to both the drug candidate and its metabolites (transient and stable). Drugs can be tested for hours (acute toxicity) or weeks/months (chronic toxicity).

We analyze the toxicological effects using various assays including, cell survival, HPLC and/or our highly sensitive and comprehensive proteomics (looking especially for early toxicological markers) providing a uniquely sensitive test system.

We can use our hepatic ProtoTissue for high-validity human acute and chronic toxicological evaluation of compounds or combinations of compounds.

Our toxicological tests can be used very early in drug development even before animal studies are initiated. The very early identification of compounds, which are toxic to our hepatic ProtoTissue, increases the success rate of a drug development program while significantly reducing costs and time to market.

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