CiToxLAB, a leading CRO in the field of non-clinical research, announces today its partnership with KaLy-Cell, a company specialized in the evaluation of hepatic toxicity and in vitro and ex vivo metabolism tests. This partnership will allow both companies to meet the growing demand from clients in the pharmaceutical, biotech and chemical industries for predictive tests to evaluate hepatotoxicity and to perform metabolism studies during product development.

KaLy-Cell was founded in 2003 by Professor Lysiane Richert. It offers in vitro and ex vivostudies to evaluate hepatotoxicity and detect potential drug-drug interactions. This unique expertise is documented in numerous scientific publications and is acknowledged by international pharmaceutical companies. KaLy-Cell is a partner in a number of European projects (such as EuroTransBio and IMI), bringing together hospitals, pharmaceutical companies and renowned university laboratories. It also contributes to the validation of regulatory tests in collaboration with EURL-ECVAM, the European reference laboratory for alternatives to animal testing.

With this partnership, in vitro and ex vivo testing (using hepatocytes and liver microsomes) will allow companies to evaluate hepatotoxicity and the potential effects linked to hepatic metabolism disorders; at early stages and during preclinical and clinical phases of development. The use of cultured multi-species hepatocytes will allow companies – to evaluate in vitro hepatic clearance (metabolite stability), – to identify the structure of resulting metabolites (Qtrap Orbitrap – Q exactive™), – to identify potential drug-drug interactions (cytochrome P450 and transporters), – to determine endocrine disrupting potential (i.e. thyroid and steroidal hormones), – to investigate the mechanisms using transcriptomics (AffymetrixTM technology or RT-PCR).

Dr. Jean-François Le Bigot, Chairman of CiToxLAB Group said: “We identified KaLy-Cell as a strategic partner, given that hepatotoxicity is still one of the most common causes for terminating a candidate drug’s development process and a significant factor in the refusal of marketing authorization for a drug or for restrictions on its use. Predicting potential toxicity during drug development is therefore a major issue for our clients. Early knowledge of drug metabolism through cellular models of animal and human hepatocytes is essential and contributes to rational choices, particularly the choice of the non-rodent species used during preclinical development.”

Pr. Lysiane Richert, Scientific Director of KaLy-Cell added: “We are particularly proud of this exciting partnership with the CiToxLAB Group. CiToxLAB offers testing capabilities in many preclinical models and state-of-the-art platforms in bioanalysis and metabolites characterization, along with a transcriptomic approach. This partnership will enable us to offer clients a full range of in vitro and ex vivo hepatotoxicity and metabolism tests in a comprehensive and integrated manner. KaLy-Cell’s large library of human hepatocytes will also allow integration of the notion of genetic polymorphism in the evaluation of a compound’s toxicological risk.“

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