Human Hepatocytes, Cryopreserved, Plateable and Interaction Qualified
Human Hepatocytes, Cryopreserved, Plateable and Interaction Qualified
Cryopreserved Human Hepatocytes, Plateable and Interaction Qualified are characterized for 3 major mechanisms of Drug-Drug interactions: transporter activity, enzyme activity, and induction potential, providing you with one product to meet more of your hepatocyte DDI study needs Each ampule contains >5 million cells.
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Product Overview
Clinically relevant drug-drug interactions (DDI) are a serious concern for any new drug development project.
To better support capturing the multiple mechanisms of DDI potential using cryopreserved primary human hepatocytes, we now offer Interaction Qualified Cryopreserved Human Hepatocytes (Catalog HUCPI) which are characterized for 3 major mechanisms of DDI:
- Transporter activity
- Enzyme activity
- Enzyme gene induction potential.
Interaction Qualified Cryopreserved Human Hepatocytes have the following features and benefits:
Benefits
- Use the same donor for basal clearance, transport, and induction studies
- Actual rates of transport reported rather than relative rates for less ambiguity
- Large lots mean fewer rounds of testing so you can focus on results
- Prequalified in Lonza media for better reproducibility
Features*:
- Confluent monolayer with cobblestone morphology, distinct nuclei, and tight junctions for 5 days or more
- Inducibility of enzyme activity for CYP3A4, CYP2B6, and CYP1A2
- Inducibility of mRNA for CYP3A4, CYP2B6, CYP1A2, and CYP2C8 genes
- Actual rate of uptake or efflux for OATP1B1/3, OCT1/2, NTCP, and BSEP** transporters
- Differences in passive vs. active uptake for OATP1B1/3, OCT1/2, and NTCP transporters.
- Basal metabolism for 8 CYPs, SULT, UGT, and aldehyde oxidase
- Plated low-turnover clearance for CYP2C9, CYP2D6, and CYP3A4
- Complementary thawing, plating, and maintenance medium available
- > 5 million viable cells/vial
- Characterized for long-term culture potential (> 7 days)
- Characterized for spheroid formation potential
Our qualification methods for cryopreserved human hepatocytes are modelled after recommendations from the FDA publication In Vitro Metabolism and Transporter Mediated Drug-Drug Interaction Studies Guidance for Industry (2017, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm) .
*Currently, older batches may not have a complete data set of characteristics listed
***BSEP efflux activity is measured using method described in Jie Zhang, et al., Chemico-Biological Interactions, Volume 255, 2016, Pages 45-54,
Benefits
- Use the same donor for basal clearance, transport, and induction studies
- Actual rates of transport reported rather than relative rates for less ambiguity
- Large lots mean fewer rounds of testing so you can focus on results
- Prequalified in Lonza media for better reproducibility
- Pre-tested for long-term culture, spheroid formation, and 96-well compatibility
Applications
- Drug-Drug interaction studies
- Low clearance metabolism studies
- Drug uptake and efflux
- Disease modeling
- Xenotransplantation
- Short term cellular toxicity studies
- 3D cell culture
Storage and Content
Cryopreserved ampule of HUCPI containing >5 million viable cells
SDS, CoA, and Instructions
Safety Data Sheets (SDS)
Choose a language to view the SDS.
Certificate of Analysis (CoA)
Please enter Lot Number, including all zeros, located on the product label and please take into account that it is case sensitive.
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Induction of Cytochrome P450 subtypes 1A2, 2B6, and 3A4 using Primary Human Interaction Qualified Hepatocytes
Technical information & instructions for enzyme activity assessment -
Instructions & Technical Info - Cryopreserved Hepatocyte Cell Systems
Technical information and instructions for culturing cryopreserved primary hepatocytes in suspension or plated formats -
Hepatocytes and Non-parenchymal Cells - Development and Optimization of a Comprehensive Co-Culture
Tech Note detailing the development of a co-culture protocol for Heps and NPCs -
Long-Term Culture of Primary Human Hepatocyte 3D Spheroids and Cytotoxicity Assay
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Hepatocytes KC Cell Co-Culture Protocol
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Measuring Hepatotoxicity in Primary Human Hepatocyte 3D Spheroid Using ViaLight Plus Cytotoxicity BioAssay
Protocol for using ViaLight Plus to measure cytotoxicity in hepatocyte 3D spheroids -
3D Spheroid Primary Human Hepatocyte and Non-Parenchymal Cell (NPC) Co-Culture - Instructions for use
Educational Material
Brochures, White Papers etc.
Videos
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A Novel in vitro Liver Cell Culture Flow System Allowing Long-term Metabolism and Hepatotoxicity Studies
Lonza Scientific poster. Here we present an alternative in vitro model that is based on the long-term culture of PHH in the Quasi Vivo® QV900 flow system. -
Primary Human Hepatocyte Spheroid Generation and Performance in Culture Systems
This poster presents a study in which our scientists analyzed and optimized the formation, culture and performance of PHH in different spheroid culture systems and under various culture conditions. -
Webinar - Hepatocytes in the Drug Development Pipeline
Overview of how primary hepatocytes are used in drug development -
Supporting In Vitro ADMETox with an Advanced Portfolio of Primary Cells and Media
Reference to Help Get Started on Primary Cell Culture for ADMETox Applications -
Development of a Long-term Primary Hepatocyte 3D Spheroid Model
For Use in DILI Applications using ViaLight Plus Cytotoxicity BioAssay Kit -
Primary Human Hepatocyte 3D Spheroids Co-cultured with Non-Parenchymal Cells
High Throughput Meets Physiological Relevence -
Primary hepatocytes in RAFT™ 3D Cell Culture System - A model for hepatocyte toxicity studies
A whitepaper reporting a 3D hepatocyte model constructed using the RAFT™ 3D Cell Culture System and characterization.
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Designed for Purpose – Complex Liver Cell Cultures for Improving In Vitro Hepatotoxicity Testing
Recording of SOT 2018 Symposium presented by Drs. Jessica Hartman and Martin Phillips. -
Hepatocyte Spheroid formation – Cytotoxicity Control
Continuous monitoring of spheroid health in vehicle control sample using Incucyte® Cytotox Green Dye. Primary human hepatocyte spheroids were treated with vehicle (cell culture media along with Incucyte® Cytotox green dye at 25 nM final concentration) and imaged in green fluorescence over 21 days with no drug exposure. Spheroids were generated using 1,500 cells/well in Corning® ultra-low attachment 96-well plates in spheroid formation media (Lonza HBMTM basal media supplemented with HCM SingleQuots® Kit, 20% FBS and 25 mM HEPES). After spheroid formation by day 7, 50% serum-free media change (HBMTM basal media supplemented with HCMTM SingleQuots® Kit and 25 nM Cytotox green dye) was performed every 2-3 days until final culture day (28 days). -
3D Cultures of HepaRG™ Cells Model Physiologically Relevant Drug Metabolism, Drug-Induced Liver Injury, and Hepatic Signaling Pathways
Recording of SOT 2018 Symposium presented by Dr. Stephen Ferguson. -
Hepatocytes in the Drug Development Pipeline
Webinar describing how hepatocytes are used in drug development delivered by Dr. Salman Khetani, Professor at University of Illinois, Chicago.
