Corning® Gentest? Plateable Human CryoHepatocytes
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Corning® Gentest™ Plateable Human CryoHepatocytes Corning Gentest plateable cryopreserved hepatocytes are prescreened, application-specific products designed to save researchers time evaluating multiple lots. Each lot is characterized for transporter-mediated uptake and biliary efflux activity, high metabolic activity for low clearance drugs, and enzyme induction. These characterizations provide researchers with the data necessary to select lots which are well-suited to their research needs. Features w Supports ADME assays such as drug metabolism, induction, transporter, and toxicity studies w Promotes high viability, high recovery, and high plating efficiency when using a combination of Corning Gentest plateable hepatocytes and Corning Gentest high viability recovery and plating medium w Supports long-term, multi-site studies with typical lots >500 vials w Transporter-Qualified Hepatocytes: - emonstrate extensive bile canaliculi formation for assessing D drug efflux transport when using a combination of Corning Collagen I as the surface and a Corning Matrigel® overlay - upport expanding FDA-recommended studies for efflux (P-gp, S BCRP) and uptake (OATP1B1, OATP1B3) transporters w Metabolism-Qualified Hepatocytes: - xtend time course of metabolic activity when using plateable E human cryopreserved hepatocytes compared to cells in suspension; ideal for evaluating the metabolic stability of slowly metabolized test compounds - emonstrate high Midazolam clearance, consistently D >0.2 mL/hr/million cells, and metabolite formation activity for P450 and UGT enzymes w Inducible-Qualified Hepatocytes: - atisfy FDA recommended fold induction for important P450s S - emonstrate physiologically relevant basal activity and fold D induction when using a combination of Corning Gentest hepatocytes, Corning Matrigel thin-coat surface, and Corning Matrigel overlay compared to conventional Collagen I surfaces Pre-qualification for plateable hepatocyte applications helps researchers select hepatocytes well-suited to their needs Lots are qualified for transporter, metabolism, and induction assays, and data is reported for relevant assays. This data provides researchers convenience and flexibility to select the best lot(s) for their application(s). Note: Some lots may be suitable for more than one assay type. Characterization data provides insights into key applications High viability, high quality lots are characterized for their cell morphology, bile canaliculi formation for studying hepatic uptake and efflux transporters, metabolic activity for intrinsic clearance measurement and metabolite formation, and drug metabolizing enzyme induction. On average Corning Gentest plateable cryopreserved hepatocyte lots demonstrate cell viabilities of ≥85%, with most lots having cell viabilities of ≥90%, and confluency of ≥80%. High viability and superior morphological attributes provide confidence that the cells have retained hepatic functions. Extensive supply of large lots provides consistent data for multi-year studies and multiple sites Corning provides researchers with an extensive selection of plateable hepatocyte lots typically with >500 vials. These large lots are ideal for long-term, multi-site projects, where reproducible data is desirable.

Substrate (Positive control inducer) Transporter Metabolism Induction Metabolite Formation 5 µM CDFDA (hydrolysis product CDF, 5-(and-6)-carboxy-2’,7’-dichlorofluorescein) Intrinsic Clearance Uptake Transport Efflux Transport Figure 1. Probe substrates and positive control inducers used for testing drug transport, metabolism, and induction applications. Characterization uses industry-accepted transporter and metabolism probe substrates, and positive control inducers allow researchers to easily compare the data provided with literature values. Confluent cryopreserved hepatocyte monolayer in...

NTCP Activity in Sandwich Cultured Corning Gentest Human Cryopreserved Hepatocytes OATP Activity in Sandwich Cultured Corning Gentest Human Cryopreserved Hepatocytes Rosuvastatin Uptake (pmol/mg) Figure 3. Uptake transporters (NTCP and OATP) in Corning® Gentest™ cryopreserved hepatocytes are evaluated using 1 μM Taurocholic acid (TCA) and 2 μM Rosuvastatin respectively. The Uptake rate of TCA and Rosuvastatin in Lot 262 and Lot 295 is summarized in the table. Uptake Activity (pmol/mg/min) TCA (NTCP) Rosuvastatin (OATP) Sandwich culture of Corning Matrigel® thin-coat surface and Corning...

Important Ordering Information HepatoLink® is the Corning immediate response system providing researchers with instant notification when Corning® Gentest™ hepatocyte products are available. For your convenience, select a preferred contact method—e-mail, phone, and/or SMS text alerts. Upon registration, you will be sent donor characterization data when a new lot becomes available. Register online at www.corning.com/lifesciences/hepatolink. Place your order directly through Corning’s online system. If you have any questions regarding Corning’s program or your participation, please contact us...