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Corning® Enzyme Induction Studies

Corning® Enzyme Induction Studies
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Corning® Enzyme Induction Studies Cytochrome P450 and UGT Induction The most rapid path to more sound decision making Induction of cytochrome P450 and UGT enzyme catalytic activity is a leading mechanism of metabolism-based drugdrug interactions. In vitro induction studies are valuable predictors of in vivo drug-drug interactions and the magnitude of that interaction. SM Corning Gentest Contract Research Services utilizes high quality, highly characterized Corning Gentest™ human and animal hepatocytes, as well as Corning chemicals and cultureware to deliver robust, reproducible results. The combination of proprietary products, advanced technology and expert guidance from renowned study directors provides clients with reliable, submission-ready results. Features w Testing for enzyme activity, mRNA or western blotting for a comprehensive portfolio of inducible enzymes, including CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, UGTs and transporters w Fully validated LC/MS/MS analytical methods for the major inducible CYPs in enzyme activity assays w Flexibility to adapt to clients’ needs to customize testing conditions for comparison with in-house data w Use of highly characterized Corning Gentest Inducible- qualified cryopreserved hepatocyte cells for predictable results w Use of customer-reserved lots of cryopreserved hepatocytes for consistent comparisons over extended periods w High quality submission-ready data analysis w Expert Study Directors who deliver assays aligned with FDA and EMA recommendations w Induction of Cytochrome P450 and UGT in animal livers ex vivo w Strict tissue traceability and sourcing from US-based Organ Procurement Organizations that meet high ethical standards Extensive Suite of Assays For more than ten years, Corning has been providing regulatory agency submission-quality enzyme induction services in human hepatocytes. Corning induction assays go beyond the standard CYP1A2, 2B6 and 3A4 tests. Additional enzymes that may be requested by regulatory agencies are available with enzyme activity, mRNA or western blot endpoints, including CYP2C8, CYP2C9, CYP2C19, UGTs and transporters. Assay Flexibility and Customization Corning provides induction assays using both cryopreserved and fresh hepatocytes to meet EMA and FDA draft guidance recommendations for regulatory filings. Using pre-qualified Corning Gentest inducible hepatocytes ensures a predictable response and accelerated data availability. Corning has expertise in adapting clients’ protocols to facilitate comparison with in-house databases. Customizations can include the choice of extracellular matrix, treatment media, seeding density, positive control-inducing chemical concentration and delivery solvent, as well as many other clientspecified adaptations. High Quality Reagents, Extensive Selection and Supply Corning has an extensive portfolio of high viability hepatocytes that are pre-qualified to meet any researcher’s hepatocyte criteria, including CYP3A4, CYP2B6 and CYP1A2 fold induction, and basal and induced activity. The large lot sizes provide researchers the benefit of using the same lot for long-term, multi-site projects including the client’s in-house studies, where reproducible and comparative data is desirable.

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Robust Dynamic Range to Assess Induction Response Assay Method Enzyme activity in situ or with hepatocyte microsomes, mRNA by real-time RT-PCR, and protein by western blot Recommended CYP1A2, CYP2B6, Profile CYP3A4 Other available enzymes: CYP2C8, CYP2C9, CYP2C19, UGTs, and transporters Data Endpoints Fold induction, percent positive control, EC50 and EMAX (where applicable) Report Regulatory agency submission-ready CYP Assays and Substrates P450 Enzyme Positive Control Inducer CYP1A2 Omeprazole, ß-naphthoflavone CYP2B6 Phenobarbital CYP2C8 Rifampin CYP2C9 Rifampin CYP2C19 Rifampin CYP3A4...

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