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 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 (guaranteed 4-fold or greater activity change)
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
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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) .
*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,
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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
Applications
DMPK studies
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
