Drug Metabolism and Safety Toxicity Testing Services
CN Bio supports R&D efforts via fast-track Drug Metabolism and Safety Toxicity Testing Services that deliver human translatable insights from lead candidates in a few weeks and at lower cost than animal studies. By accessing the Company’s expertise and advanced in vitro liver-on-chip models, these Services enable researchers to step beyond standard in-house laboratory workflows for better informed pre-clinical decisions.
In vitro Drug Metabolism and Safety Toxicity Testing Service
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Why does CN Bio offer Drug Metabolism and Safety Toxicity Testing Services?
Standard in vitro DMPK studies face many challenges including incompatibility with new therapeutic modalities, inaccurate predictions of human in vivo clearance rates (particularly for low-clearance compounds) and missing rare, or human specific metabolites.
Additionally, with safety concerns being the principal cause for failures in phases 1 and 2 of clinical trials, it is clear that more predictive models are required within drug discovery and development to improve translatability.
Whilst advanced human in vitro 3D liver-on-chip models address these workflow challenges, it takes time and resources to recruit the relevant expertise, develop and validate these assays in-house. Alternatively, CN Bio’s fast-track Services enable scientists to submit lead candidates for immediate test using models developed over years of research, backed by peer-reviewed publications, and collaborative work with the FDA.
Drug Metabolism Testing Services Overview
Study the human metabolism of lead candidates, identify metabolites and correlate with cell health - even for low-clearance compounds.
- Individual human donors, or pools from varying genetic backgrounds, ethnicities, age and gender
- Full range expression of CYP enzymes (cytochrome p450s)
- High metabolic activity maintained for at least four weeks
- Generate temporal human metabolite profiles capturing phase I & II metabolism
- Correlate drug metabolite production with cell health measurements
- Quantify clearance rates, even for slowly metabolized drugs (5 ml/min/kg)
- Compatible with small molecules, antibodies, viral vectors, ASOs and other new modalities
- Induction, inhibition and drug-drug interaction studies
- Adaptable to model the effects of disease/inflammation on metabolism
- Cultures maintained under flow perfusion using the PhysioMimix™ OOC Microphysiological System
Toxicity Testing Services Overview:
In-depth analysis of acute or chronic drug-induced liver injury (DILI) using a wide range of endpoints to determine causality and mechanism of toxicity.
What are the benefits?
- Highly functional hepatocyte and NPC co-cultures for up to four weeks
- Compatible with small molecules, antibodies and many new modalities (e.g. viral vectors, ASOs)
- Report an almost exponential number of functional liver-specific endpoints (including LDH, Albumin, Urea, ATP, WST-1)
- Quantify clinical markers (AST/ALT, miR122)
- Produce distinct hepatotoxin signatures
- Explore inter-organ crosstalk
- Inflammatory-mediated toxicity
- Stratification of patient populations
- Cultures maintained under flow perfusion using the PhysioMimix™ OOC Microphysiological System
CN Bio’s Drug Metabolism and Safety Toxicity testing Services provide:
- Immediate access to advanced human 3D liver-on-chip models and expertise
- Rapid, low-cost data generation versus animal studies
- A solution to the shortfalls of standard workflows
- Human relevant data that better translates into clinical studies
- Improved odds of clinical success
