CiToxLAB and KaLy-Cell join to address drug development threat, hepatotoxicity
Contract research organisation (CRO) CiToxLAB said the collaboration, which focuses on hepatotoxicity development in clinical and preclinical phases, will allow the firms to meet a growing client demand.
“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 authorisation for a drug or for restrictions on its use,” said CiToxLAB CEO Jean François le Bigot
“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,” he said.
Employing in vitro and ex vivo testing (utilising hepatocytes and liver microsomes), the partnership will identify the development of liver damage, identify drug-drug interactions (DDI), and evaluate possible effects related to hepatic metabolism disorders.
Scientific director Lysiane Richert said KaLy-Cell is supplying human hepatocytes to the project.
“KaLy-Cell’s large library of human hepatocytes will allow integration of the notion of genetic polymorphism in the evaluation of a compound’s toxicological risk,” she said.
Le Bigot told Outsourcing-Pharma.com CiToxLAB had invested in the project.
“CiToxLAB has invested during the last 12 months to support this new service, in particular in mass spectrometry technology for metabolite identification (orbitrap). A panel of validation studies has also been performed,” he said.
The in vitro / ex vivo metabolism and Drug-Drug Interactions (DDI) studies will be performed at CiToxLAB’s Evreux, France-based facility, and a team of 32 staff members, made up of CiToxLAB and KaLy-Cell employees, will work on the project.
