KaLy-Cell is a true partner in the field of hepatocytes for both drug development and cell therapy. The company offers a variety of in vitro contract studies for drug candidate safety evaluation, but also provides an extensive selection of high-quality products for drug metabolism and safety assessment.
KaLy-Cell provides contract research with the aim to optimize hepatocyte use for in vitro-based ADME-Tox prediction in humans as well as to assess the efficacy of liver cell therapy for the treatment of acute and chronic liver failure.
Drug metabolism and drug transport are major determinants of drug clearance, interindividual pharmacokinetic differences, clinical efficacy, and toxicity of drugs. Inappropriate pharmacokinetics can result in inadequate pharmacodynamic action and/or extremely wide variations in clinical response leading to failure of new chemical entities in drug development in man. Hepatic metabolism of drugs as well as their interactions with hepatic transporters may cause toxicity and contribute to the variability between individuals in susceptibility to such adverse drug reactions. Therefore, key issues in the early phase of drug discovery and development include not only an exhaustive characterization of pharmacological activity, but also investigation of metabolic stability, metabolite profiles, major metabolic routes involved in metabolite formation, the enzymes involved, and the potential for enzyme inhibition or induction.
KaLy-Cell and CiToxLab have joined forces to provide researchers ex vivo and in vitro preclinical metabolism studies with xenobiotics in various species
KaLy-Cell scientists have extensive experience in hepatocyte isolation, cryopreservation and culturing as well as in vitro and ex vivo ADME-Tox assays.
CiToxLab scientists have extensive experience in analytics an in vitro and ex vivo ADME-Tox assays.
By combining our expertise in cell and molecular biology, mechanistic toxicology and analytics, we provide incomparable evaluation of drug candidates for mechanisms of toxicity, drug-drug interactions and safety assessments as recommended by the FDA.
Drug toxicity, often manifested as liver toxicity, is a key reason for drug attrition. Identifying potential toxicity at an early stage in drug discovery can save both time and developmental costs, and most importantly reduce the likelihood of late stage failure.
KaLy-Cell is the ideal partner to assist you in understanding the toxic liability of your compounds using a panel of different techniques. Our focus on state of the art technique allow for high quality data to be generated rapidly and cost-effectively. To that end, KaLy-Cell is actively involved in several R&D projects to improve the prediction of toxicological events and allows for a better understanding of the mechanisms of drug toxicity.
KaLy-Cell offers innovative ex vivo and in vitro read outs of toxicity including drug-induced oxidative stress, steatosis, cholestasis, toxicological gene regulation and a range of drug-drug interaction screens (available via KaLy-Cell in vitro and ex vivo Metabolism services).
KaLy-Cell offers in vitro-based Drug Induced Cholestasis (DICI) as well as a Drug Induced Liver Injury (DILI) prediction services. In order to reach the highest level of prediction from the earliest stage of drug development process, KaLy-Cell has optimized those endpoints for the most relevant cell models by using human and rat primary hepatocyte cell cultures.
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