标签：Cryopreserved

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.

冷冻保存的人类肝细胞、可铺板和相互作用认证具有药物-药物相互作用的 3 种主要机制的特征：转运蛋白活性、酶活性和诱导潜力，为您提供一种产品来满足您更多的肝细胞 DDI 研究需求每个安瓿含有 >500 万 细胞。

Product Overview

临床相关的药物-药物相互作用 (DDI) 是任何新药开发项目的一个严重问题。

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,