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Pharma & Biotech

Human Hepatocytes, Cryopreserved, Plateable and Interaction Qualified

Catalog #: HUCPI

Cryopreserved Human Hepatocytes, Plateable and Interaction Qualified are characterized for 3 major mechanisms of DDI: 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 primary hepatocytes, we now offer Interaction Qualified Human Hepatocytes (Catalog HUCPI) which are characterized for 3 major mechanisms of DDI: transporter activity, enzyme activity, and induction potential, providing you with one product to meet more of your hepatocyte DDI study needs.

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*:

  • 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

 

Our qualification methods 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

Content & Storage

Content

Cryopreserved ampule of HUCPI containing >5 million viable cells

Instructions

Safety Data Sheets (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.

Webinar -Hepatocytes in the Drug Development Pipeline

Overview of how primary hepatocytes are used in drug development

Human Hepatocyte Inventory

Human

Inventory

View donor information and select characteristics of currently available human hepatocyte lots. Table includes single donor and pooled donor lots in either suspension or plateable formats

5 Reasons your Hepatocyte Culture May Have Failed

Tips and Tricks

See the 5 main reasons that can cause suboptimal hepatocyte culture outcomes and how to overcome these pitfalls.

Guide to spheroid formation using Verified for SpheroidsTM Human Hepatocytes

Tech Note

Use this protocol for spheroid formation with our Verified for SpheroidsTM Human Hepatocytes to support your next steps towards more physiologically relevant liver cell culture systems.

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